MASH / Nonalcoholic Steatohepatitis trial readouts
registry pull 2026-08-19Primary-completion dates that listed drug and biotech companies filed with ClinicalTrials.gov for studies in MASH / Nonalcoholic Steatohepatitis. They are the sponsor's own estimated windows, revised as a study runs — not announcement dates. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Upcoming readout windows
next 180 days · by month4 studies across 2 companies, in the next 180 days.
August 2026 1
| Ticker | Name | Study | Phase | Status | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|
| CORT | Corcept Therapeutics | Evaluation of Miricorilant on Liver Fat in Patients With MASLDNCT06947304Change in fasting hepatic lipogenesis after 6 weeks of treatment | Phase 1 | Active, not recruiting | Aug 2026 | ≤ 11 d | 2026-07-30 |
September 2026 1
| Ticker | Name | Study | Phase | Status | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|
| CORT | Corcept Therapeutics | A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)NCT06108219Percent relative change from Baseline in liver-fat content assessed by MRI-PDFF (Cohort A and Cohort B) | Phase 2 | Active, not recruiting | Sep 2026 | ≤ 41 d | 2026-05-08 |
October 2026 1
| Ticker | Name | Study | Phase | Status | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|
| CORT | Corcept Therapeutics | Evaluating the Pharmacokinetics and Safety of MiricorilantNCT07553663Assessment of miricorilant PK parameters | Phase 1 | Recruiting | 2026-10-30 | in 71 d | 2026-05-26 |
December 2026 1
| Ticker | Name | Study | Phase | Status | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|
| MDGL | Madrigal Pharmaceuticals, Inc. | A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)NCT05500222Incidence Of adjudicated Composite Clinical Outcome event | Phase 3 | Active, not recruiting | Dec 2026 | ≤ 133 d | 2026-07-08 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Every registered study in MASH / Nonalcoholic Steatohepatitis
most recently updated first112 studies match. Showing the first 100 of 112 studies — page through, or narrow the filters.
| Ticker | Name | Market cap | Study | Phase | Status | Interventions | Conditions | Enrollment | Start | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MDGL | Madrigal Pharmaceuticals, Inc. | $12.1B | Study of Resmetirom in Children and Adolescents With MASHNCT07763015Safety and tolerability of multiple ascending doses of resmetirom | Phase 2 | Not yet recruiting | Drug: Resmetirom | MASH, MASH - Metabolic Dysfunction-Associated Steatohepatitis | 61 | Aug 2026 | Jul 2029 | ≤ 1,076 d | 2026-08-13 |
| NVO | Novo Nordisk A/S | — | Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)NCT04822181Part 1: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No) | Phase 3 | Active, not recruiting | Drug: Semaglutide, Placebo | Non-alcoholic Steatohepatitis | 1,205 | 2021-04-01 | 2029-04-25 | in 979 d | 2026-08-04 |
| MDGL | Madrigal Pharmaceuticals, Inc. | $12.1B | Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASHNCT07335601Percent change from baseline in liver fat content (LFC) as assessed by MRI-PDFF at Week 28 | Phase 2 | Recruiting | Drug: Resmetirom, Placebo | MASH - Metabolic Dysfunction-Associated Steatohepatitis | 120 | 2025-12-29 | Aug 2028 | ≤ 742 d | 2026-07-31 |
| OPK | OPKO Health, Inc. | $1.0B | Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH ParticipantsNCT07512427SAD - OPK-88006 maximum plasma concentration (Cmax) | Phase 1/2 | Recruiting | Drug: OPK-88006, Placebo | MASH | 30 | 2026-07-24 | Dec 2027 | ≤ 498 d | 2026-07-31 |
| CORT | Corcept Therapeutics | $12.8B | Evaluation of Miricorilant on Liver Fat in Patients With MASLDNCT06947304Change in fasting hepatic lipogenesis after 6 weeks of treatment | Phase 1 | Active, not recruiting | Drug: Miricorilant | Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH), Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Non-alcoholic Fatty Liver Disease (NAFLD) | 9 | 2025-08-22 | Aug 2026 | ≤ 11 d | 2026-07-30 |
| AZN | AstraZeneca | — | Non-alcoholic Steatohepatitis Registry Platform StudyNCT06123858observational1.Patient demography | — | Terminatedsponsor's stated reason: Following a reassessment of the company's pipeline priorities, the sponsor has elected to discontinue this project prior to its planned completion | — | NASH With Fibrosis | 1,122 | 2023-11-22 | 2025-10-17actual | — | 2026-07-29 |
| MDGL | Madrigal Pharmaceuticals, Inc. | $12.1B | A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)NCT05500222Incidence Of adjudicated Composite Clinical Outcome event | Phase 3 | Active, not recruiting | Drug: Resmetirom, Placebo | NASH, Cirrhosis, Liver | 845 | 2022-08-26 | Dec 2026 | ≤ 133 d | 2026-07-08 |
| REGN | Regeneron Pharmaceuticals | $76.1B | A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This ConditionNCT05519475Change in quantitative liver Fibrosis (qFibrosis) | Phase 2 | Recruiting | Drug: ALN-HSD, Placebo | Metabolic Dysfunction-Associated SteatoHepatitis (MASH) | 120 | 2023-02-09 | 2028-04-27 | in 616 d | 2026-07-08 |
| REGN | Regeneron Pharmaceuticals | $76.1B | A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)NCT06836609Incidence of Treatment-Emergent Adverse Events (TEAEs) | Phase 1/2 | Recruiting | Drug: ALN-CIDEB, Placebo | Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis | 132 | 2025-04-28 | 2027-05-15 | in 268 d | 2026-07-08 |
| GALT | Galectin Therapeutics Inc. | $355M | Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH CirrhosisNCT04365868results2026-06-30Proportion of Patients in the Belapectin Treatment Groups Who Develop New Esophageal Varices at 78 Weeks [18 Months] of Treatment Compared to Placebo | Phase 2/3 | Terminatedsponsor's stated reason: Based on FDA feedback, Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was not prematurely terminated for safety reasons. | Drug: belapectin, Placebo | Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis, Cirrhosis | 357 | 2020-06-25 | 2025-03-11actual | — | 2026-06-30 |
| LLY | Eli Lilly and Company | $1.15T | A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)NCT05395481Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration | Phase 1 | Completed | Drug: LY3849891, Placebo | Metabolic Dysfunction-Associated Steatohepatitis (MASH), Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) | 115 | 2022-06-08 | 2026-05-12actual | — | 2026-06-24 |
| REGN | Regeneron Pharmaceuticals | $76.1B | Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)NCT07631637Percent change from baseline in liver fat by Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF) | Phase 2 | Not yet recruiting | Drug: ALN-CIDEB, Placebo | Metabolic Dysfunction-Associated Steatohepatitis (MASH) | 150 | 2026-07-15 | 2029-02-06 | in 901 d | 2026-06-08 |
| MDGL | Madrigal Pharmaceuticals, Inc. | $12.1B | A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and FibrosisNCT03900429Week 52 Dual Primary Objectives: To determine the effect of 80 or 100 mg MGL-3196 vs matching placebo on liver biopsy (NASH CRN score) at Week 52 compared with Baseline | Phase 3 | Active, not recruiting | Drug: MGL-3196, Placebo · Procedure: Liver Biopsy | NASH - Nonalcoholic Steatohepatitis | 1,759 | 2019-03-28 | Jan 2028 | ≤ 529 d | 2026-06-01 |
| CORT | Corcept Therapeutics | $12.8B | Evaluating the Pharmacokinetics and Safety of MiricorilantNCT07553663Assessment of miricorilant PK parameters | Phase 1 | Recruiting | Drug: Miricorilant | Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis, Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Non-alcoholic Fatty Liver Disease (NAFLD) | 15 | 2026-04-30 | 2026-10-30 | in 71 d | 2026-05-26 |
| ALT | Altimmune, Inc. | $578M | IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)NCT05989711Proportion of subjects achieving NASH resolution (NAFLD activity score [NAS], ballooning = 0; lobular inflammation = 0, 1) with at least a 2-point reduction in NAS without worsening of fibrosis | Phase 2 | Completed | Drug: Pemvidutide, Placebo | Non-Alcoholic Steatohepatitis (NASH) | 212 | 2023-07-27 | 2025-11-25actual | — | 2026-05-18 |
| CORT | Corcept Therapeutics | $12.8B | A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)NCT06108219Percent relative change from Baseline in liver-fat content assessed by MRI-PDFF (Cohort A and Cohort B) | Phase 2 | Active, not recruiting | Drug: Miricorilant (Cohort A), Placebo (Cohort A), Miricorilant (Cohort B), Placebo (Cohort B) | Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-associated Steatohepatitis (MASH) | 175 | 2023-10-25 | Sep 2026 | ≤ 41 d | 2026-05-08 |
| MDGL | Madrigal Pharmaceuticals, Inc. | $12.1B | Rezdiffra Pregnancy and Lactation RegistryNCT07541469observationalPregnancy and Infant Outcomes Among Women Exposed to Rezdiffra During Pregnancy and/or Lactation | — | Recruiting | Drug: Rezdiffra | MASH - Metabolic Dysfunction-Associated Steatohepatitis | 10 | 2026-03-04 | 2030-04-08 | in 1,327 d | 2026-04-21 |
| NVO | Novo Nordisk A/S | — | A Multi-country, Cross-sectional Quantitative Study Exploring Awareness, Understanding, and Perceptions of the Relation Between Cardiorenal Metabolic Conditions and MASLD/MASH Among Healthcare Providers, People With MASLD/MASH, and At-risk PopulationNCT07201831observationalDescription of awareness, understanding, and perception of MASLD/MASH, comorbidities, and risk factors | — | Completed | Other: No treatment given | Metabolic Dysfunction-associated Steatohepatitis (MASH) | 1,330 | 2025-10-02 | 2026-01-17actual | — | 2026-03-12 |
| MDGL | Madrigal Pharmaceuticals, Inc. | $12.1B | Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)NCT02912260results2025-12-23Percent Change From Baseline To Week 12 In Hepatic Fat Fraction Assessed By Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) | Phase 2 | Completed | Drug: MGL-3196, Placebo | Non-alcoholic Steatohepatitis | 125 | 2016-10-18 | 2017-10-25actual | — | 2025-12-23 |
| GILD | Gilead Sciences | $177.9B | Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)NCT04971785results2025-11-26Percentage of Participants Who Achieved ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 72 in Semaglutide (SEMA) + Cilofexor/Firsocostat (CILO/FIR) Fixed Dose Combination (FDC) Versus Placebo Groups | Phase 2 | Completed | Drug: Semaglutide (SEMA), Cilofexor (CILO)/Firsocostat (FIR), PTM SEMA, PTM CILO/FIR | Nonalcoholic Steatohepatitis | 457 | 2021-08-09 | 2024-11-12actual | — | 2025-11-26 |
| AZN | AstraZeneca | — | A Study to Assess the Safety and Tolerability of Single Doses of AZD4076 in Healthy Male SubjectsNCT02612662The safety and tolerability of AZD4076 by assessment of blood pressure | Phase 1 | Completed | Drug: AZD4076, Placebo | Non-alcoholic Steatohepatitis (NASH) | 40 | 2015-11-24 | 2017-11-04actual | — | 2025-11-19 |
| NVO | Novo Nordisk A/S | — | Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH)NCT05016882Improvement in liver fibrosis and no worsening of NASH (Yes/No) | Phase 2 | Completed | Drug: NNC0194 0499 50 mg/mL, Placebo (NNC0194-0499), Semaglutide 3 mg/mL, Semaglutide placebo, NNC0174 0833 10 mg/mL, NNC0174 0833 placebo | Non-alcoholic Steatohepatitis | 698 | 2021-08-31 | 2024-12-17actual | — | 2025-11-19 |
| AZN | AstraZeneca | — | A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With FibrosisNCT05809934Proportion of participants achieving NASH resolution without worsening of fibrosis based on histology after 52 weeks treatment | Phase 2 | Completed | Drug: AZD2693 · Other: Placebo | Nonalcoholic Steatohepatitis | 220 | 2023-03-15 | 2025-07-14actual | — | 2025-10-28 |
| ARWR | Arrowhead Pharmaceuticals | $12.4B | Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASHNCT04202354results2025-10-03Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment | Phase 1/2 | Completed | Drug: ARO-HSD Injection, sterile normal saline (0.9% NaCl) | Non-alcoholic Steatohepatitis | 50 | 2020-03-03 | 2021-09-03actual | — | 2025-10-03 |
| PII | Polaris Group | $3.8B | Study of ADI-PEG 20 Versus Placebo in Subjects With NASHNCT05842512Determine Efficacy of ADI-PEG 20 vs Placebo in the treatment of fatty liver as assessed by change in hepatic fat fraction | Phase 2 | Recruiting | Drug: ADI-PEG20 · Other: Placebo | Nonalcoholic Steatohepatitis (NASH) | 60 | 2023-09-13 | 2027-12-31 | in 498 d | 2025-09-23 |
| REGN | Regeneron Pharmaceuticals | $76.1B | A Trial to Learn if Receiving ALN-PNP siRNA is Safe and Well Tolerated, and How it Works in Adult Participants With Nonalcoholic Fatty Liver Disease (NAFLD) and a Genetic Risk FactorNCT06024408Incidence of treatment-emergent adverse events (TEAEs) | Phase 1 | Completed | Drug: ALN-PNP, Placebo | Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH), Genetic Risk Factor | 9 | 2024-05-21 | 2025-07-07actual | — | 2025-07-31 |
| AZN | AstraZeneca | — | A Randomised, Open-Label Study to Evaluate the Relative and Absolute Bioavailability of Cotadutide in Healthy SubjectsNCT05294458Absolute bioavailability of the high and the low concentration cotadutide SC formulations | Phase 1 | Completed | Drug: cotadutide solution for injection | Non-alcoholic Steatohepatitis, Type 2 Diabetes Mellitus (T2DM), Chronic Kidney Disease | 10 | 2022-03-28 | 2022-09-12actual | — | 2025-07-20 |
| AZN | AstraZeneca | — | Knockdown of HSD17B13 mRNA, Pharmacokinetics, Safety, and Tolerability, of AZD7503 in Non-Alcoholic Fatty Liver DiseaseNCT05560607Number of participants with Adverse Events (AEs). | Phase 1 | Completed | Drug: AZD7503 Intervention | Non-alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic, NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, NASH | 19 | 2022-08-12 | 2023-11-20actual | — | 2025-07-20 |
| ALT | Altimmune, Inc. | $578M | ALT-801 (Pemvidutide) in Healthy Overweight and Obese Volunteers to Study Safety and TolerabilityNCT04561245The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) | Phase 1 | Completed | Drug: ALT-801 · Other: Placebo | Obesity, Nonalcoholic Steatohepatitis | 100 | 2020-11-10 | 2021-10-29actual | — | 2025-06-24 |
| ALT | Altimmune, Inc. | $578M | Pemvidutide (ALT-801) DDI Study in Healthy VolunteersNCT04972396Area Under the Plasma Concentration Versus Time Curve (AUC) of metformin and atorvastatin/warfarin and digoxin in presence of steady state ALT-801 | Phase 1 | Completed | Drug: Pemvidutide, Metformin, Atorvastatin, Warfarin, Digoxin, Ethinylestradiol and Levonorgestrel | NASH - Nonalcoholic Steatohepatitis | 40 | 2021-09-15 | 2022-05-15actual | — | 2025-06-24 |
| SGMT | Sagimet Biosciences Inc. | $325M | A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 FibrosisNCT06594523Dual Primary Efficacy Endpoint 1: Interim Analysis: MASH Resolution (denifanstat 50 mg compared to placebo) | Phase 3 | Withdrawnsponsor's stated reason: Business decision | Drug: Denifanstat, Placebo | MASH, NASH, Metabolic Dysfunction-associated Steatohepatitis, Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis, Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver | 0 | Mar 2025 | Dec 2030 | ≤ 1,594 d | 2025-05-15 |
| SGMT | Sagimet Biosciences Inc. | $325M | A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASHNCT06692283Primary Safety Outcome Measure: TEAEs | Phase 3 | Withdrawnsponsor's stated reason: Business decision | Drug: denifanstat, Placebo | MASLD, MASH, NASH, Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis, Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver | 0 | Mar 2025 | Jun 2026 | — | 2025-05-15 |
| CORT | Corcept Therapeutics | $12.8B | Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of MiricorilantNCT05553470Area under the Concentration-Time Curve (AUC) from Time Zero to the Last Non-Zero Concentration (AUC 0-t) | Phase 1 | Completed | Drug: Miricorilant | Non-alcoholic Steatohepatitis (NASH) | 19 | 2022-03-03 | 2024-09-13actual | — | 2025-03-30 |
| VKTX | Viking Therapeutics, Inc. | $3.9B | Phase 1 Study to Evaluate the Safety and Tolerability of VK2735NCT05203237Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious AEs (TESAEs) | Phase 1 | Completed | Biological: VK2735, Placebo · Drug: VK2735 Placebo, VK2735 Drug | Weight Loss, NASH | 92 | 2021-12-14 | 2024-11-04actual | — | 2025-02-17 |
| ALGS | Aligos Therapeutics | $288M | ALG-055009 in Non-cirrhotic Adults With MASH (HERALD)NCT06342947Percent relative change from baseline in liver fat content | Phase 2 | Completed | Drug: ALG-055009, Placebo | NASH, MASH, Metabolic Dysfunction-Associated Steatohepatitis, Nonalcoholic Steatohepatitis | 102 | 2024-04-01 | 2024-08-19actual | — | 2025-02-17 |
| LLY | Eli Lilly and Company | $1.15T | A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)NCT04166773results2025-01-24Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology | Phase 2 | Completed | Drug: Tirzepatide, Placebo | Nonalcoholic Steatohepatitis | 190 | 2019-11-19 | 2023-12-11actual | — | 2025-01-24 |
| HEPA | Hepion Pharmaceuticals, Inc. | $6M | Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male SubjectsNCT05737433results2024-10-03To Determine the Mass Balance Recovery After a Single Oral Dose of [14C]-Rencofilstat | Early Phase 1 | Completed | Drug: [14C]-rencofilstat 225mg | NASH With Fibrosis | 6 | 2023-03-01 | 2023-05-01actual | — | 2024-10-03 |
| BMY | Bristol-Myers Squibb | $134.9B | Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)NCT04267393results2024-09-04Percentage of Participants Who Achieve ≥ 1 Stage Improvement in Liver Fibrosis (NASH CRN Fibrosis Score), as Determined by Liver Biopsy After 12 Weeks of Treatment. | Phase 2 | Terminatedsponsor's stated reason: Trial terminated because of lack of efficacy in the short term acute phase. | Drug: BMS-986263 · Other: Placebo | Nonalcoholic Steatohepatitis (NASH) | 124 | 2021-03-17 | 2023-08-16actual | — | 2024-09-04 |
| CORT | Corcept Therapeutics | $12.8B | A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)NCT05117489Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline. | Phase 1 | Completed | Drug: Miricorilant 150 mg, Miricorilant 100 mg, Miricorilant 50 mg, Miricorilant 10 mg | Nonalcoholic Steatohepatitis (NASH) | 70 | 2021-11-23 | 2024-01-29actual | — | 2024-08-19 |
| CORT | Corcept Therapeutics | $12.8B | A Sub Study of the Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)NCT05320146observationalChange in liver-fat content assessed by MRI-PDFF after the last dose of study drug. | — | Completed | Other: MRI-PDFF | Nonalcoholic Steatohepatitis (NASH) | 22 | 2022-03-04 | 2023-07-18actual | — | 2024-08-19 |
| CANF | Can-Fite BioPharma | — | Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)NCT04697810Non-Alcoholic Fatty Liver Disease (NAFLD) activity score (NAS) | Phase 2 | Unknown status | Drug: Namodenoson, Placebo | NASH - Nonalcoholic Steatohepatitis | 114 | 2021-12-10 | 2025-04-15 | — | 2024-07-31 |
| LPCN | Lipocine Inc. | $17M | A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 TrialNCT04685993results2024-07-17Safety and Tolerability of LPCN 1144 | Phase 2 | Completed | Drug: LPCN 1144 | NASH - Nonalcoholic Steatohepatitis | 25 | 2020-11-11 | 2022-03-01actual | — | 2024-07-17 |
| VKTX | Viking Therapeutics, Inc. | $3.9B | A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASHNCT04173065Liver Fat | Phase 2 | Completed | Drug: VK2809, Placebos | NASH - Nonalcoholic Steatohepatitis | 248 | 2019-11-15 | 2023-05-15actual | — | 2024-06-14 |
| HEPA | Hepion Pharmaceuticals, Inc. | $6M | A Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects With NASH F3NCT05461105Change from baseline in DSI score of subjects taking rencofilstat (75 mg, 150 mg, 225 mg), determined using HepQuant SHUNT Test, on Day 60, and Day 120. | Phase 2 | Completed | Drug: rencofilstat, 75 mg, rencofilstat, 150mg, rencofilstat, 225 mg | NASH With Fibrosis | 60 | 2022-03-15 | 2023-04-15actual | — | 2024-06-13 |
| NVO | Novo Nordisk A/S | — | A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver DamageNCT03987451results2024-05-29Percentage of Participants With At Least One Stage of Liver Fibrosis Improvement With No Worsening of Non-Alcoholic Steatohepatitis (NASH) After 48 Weeks | Phase 2 | Completed | Drug: Semaglutide, Placebo (semaglutide) | Non-alcoholic Steatohepatitis | 71 | 2019-06-18 | 2021-04-22actual | — | 2024-05-29 |
| ALNY | Alnylam Pharmaceuticals | $30.6B | A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)NCT04565717Parts A and B: Frequency of Adverse Events | Phase 1 | Terminatedsponsor's stated reason: Study ALN-HSD-001 was terminated due to business reasons and changes in the development strategy of the product. No safety issues were found. | Drug: ALN-HSD, Placebo | Nonalcoholic Steatohepatitis, NASH | 6 | 2020-10-09 | 2023-01-06actual | — | 2024-05-17 |
| HEPA | Hepion Pharmaceuticals, Inc. | $6M | A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver FibrosisNCT05402371Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) OR NASH resolution without worsening of fibrosis. | Phase 2 | Unknown status | Drug: Rencofilstat, Placebo | Nonalcoholic Steatohepatitis (NASH), Fibrosis, Liver, NAFLD | 120 | 2022-10-15 | May 2025 | — | 2024-05-03 |
| NVO | Novo Nordisk A/S | — | A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate FormulationsNCT05766709AUC 0-168 hour (h), 0499, steady state (SS): Area under the NNC0194-0499 concentration time curve during a dosing interval (0-168 hours) at steady state after dosing of NNC0194-0499 in combination with semaglutide | Phase 1 | Completed | Drug: NNC0194-0499, Semaglutide, NNC0194-0499/Semaglutide A (40/3.20 mg/mL), NNC0194-0499/Semaglutide A (40/0.33mg/mL) | Non-alcoholic Steatohepatitis | 53 | 2023-03-02 | 2024-01-05actual | — | 2024-02-29 |
| AZN | AstraZeneca | — | A Study to Assess Safety, Tolerability, PK and PD of AZD2693 in Non-alcoholic Steatohepatitis PatientsNCT04483947Number of participants with adverse events | Phase 1 | Completed | Drug: AZD2693 · Other: Placebo | Non-alcoholic Steatohepatitis (NASH) | 74 | 2020-11-06 | 2023-12-18actual | — | 2024-01-17 |
| SGMT | Sagimet Biosciences Inc. | $325M | A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic FunctionNCT05835180Total TVB-2640 plasma concentration-time (AUC) at steady state | Phase 1 | Completed | Drug: TVB-2640 - 50 mg | Non-alcoholic Steatohepatitis, Hepatic Impairment, Cirrhosis | 48 | 2023-05-01 | 2023-12-18actual | — | 2023-12-26 |
| LPCN | Lipocine Inc. | $17M | The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic SteatohepatitisNCT04134091results2023-12-14Absolute Change in Hepatic Fat Fraction Based on MRI-PDFF Measurements in LPCN 1144 Treated Subjects Compared to Placebo. | Phase 2 | Completed | Drug: LPCN 1144 Formulation A, LPCN 1144 Formulation B, Placebo | Nonalcoholic Steatohepatitis (NASH) | 56 | 2019-08-27 | 2021-06-24actual | — | 2023-12-14 |
| AZN | AstraZeneca | — | A Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy ParticipantsNCT05848440Adverse Events (AEs) and Serious Adverse Events (SAEs) | Phase 1 | Completed | Drug: AZD9550, AZD9550, Placebo | Non-alcoholic Steatohepatitis | 48 | 2023-05-02 | 2023-11-13actual | — | 2023-12-11 |
| NVO | Novo Nordisk A/S | — | A Research Study Looking Into Blood and Urine Levels of the Medicine NNC0194-0499 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney FunctionNCT05727644AUC0499,0-∞,SD: Area under the NNC0194-0499 serum concentration-time curve after a single dose | Phase 1 | Completed | Drug: NNC0194-0499 | Non-alcoholic Steatohepatitis (NASH) | 42 | 2023-02-15 | 2023-11-10actual | — | 2023-12-06 |
| MDGL | Madrigal Pharmaceuticals, Inc. | $12.1B | Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control SubjectsNCT04643795Plasma pharmacokinetics - Cmax | Phase 1 | Completed | Drug: MGL-3196 | Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver | 87 | 2018-10-25 | 2021-08-04actual | — | 2023-10-05 |
| ALGS | Aligos Therapeutics | $288M | A Study of ALG-055009 in Healthy Volunteers and Subjects With HyperlipidemiaNCT05090111Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Phase 1 | Completed | Drug: ALG-055009, Placebo | NASH - Nonalcoholic Steatohepatitis | 98 | 2021-12-01 | 2023-06-16actual | — | 2023-09-25 |
| POXEL.PA | Poxel SA | $11M | Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)NCT04321343results2023-08-29Relative Change From Baseline to Week 36 in the Percentage of Liver Fat Content (LFC) (Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction [MRI-PDFF]) | Phase 2 | Completed | Drug: PXL065, Placebo oral tablet | NASH - Nonalcoholic Steatohepatitis | 117 | 2020-09-01 | 2022-06-08actual | — | 2023-08-29 |
| ENTA | Enanta Pharmaceuticals, Inc | $387M | A Randomized, Double-blind Study to Assess the Safety and Efficacy of EDP-305 in Subjects With Liver-biopsy Proven NASHNCT04378010results2023-05-19Proportion of Participants Who Achieve ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis and/or Resolution of Steatohepatitis and no Worsening of Liver Fibrosis as Determined by Liver Biopsy | Phase 2 | Terminatedsponsor's stated reason: Enanta Pharmaceuticals, Inc. made the strategic decision to discontinue the ARGON-2 study to prioritize combination treatment approaches. This decision was not based on safety concerns. | Drug: EDP-305 1.5 mg, EDP-305 2 mg, Placebo | Non-Alcoholic Steatohepatitis | 98 | 2020-01-27 | 2021-10-04actual | — | 2023-05-19 |
| PFE | Pfizer | $155.3B | Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic SteatohepatitisNCT04399538results2023-04-13Percent Change From Baseline (CFB) in Percent (%) Liver Fat as Assessed Via Magnetic Resonance Imaging Using Proton Density Fat Fraction Acquisition (MRI-PDFF) at Week 6 | Phase 2 | Completed | Drug: PF-06865571, PF-05221304, Placebo | Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease | 75 | 2020-08-10 | 2022-03-31actual | — | 2023-04-13 |
| AZN | AstraZeneca | — | A Thorough QTC Study to Assess the Effect of Cotadutide on Cardiac Repolarization in Healthy ParticipantsNCT05668936Time-matched change-from-baseline Fridericia's correction of QT interval (QTcF) | Phase 1 | Terminatedsponsor's stated reason: Discontinuing the development of cotadutide, a daily injectable GLP-1/glucagon co-agonist, is based on strategic pipeline considerations. The premature closure is not due to any newly observed safety signals or a change in the risk/benefit profile. | Drug: Cotadutide, Cotadutide-placebo, Moxifloxacin, Moxifloxacin-placebo | Non-alcoholic Steatohepatitis | 31 | 2023-01-03 | 2023-03-10actual | — | 2023-04-05 |
| CORT | Corcept Therapeutics | $12.8B | Study to Evaluate the Effects of a Cytochrome P450 2C19 Inhibitor on the Pharmacokinetics of MiricorilantNCT05712265Maximum observed plasma concentration of miricorilant (Cmax) | Phase 1 | Completed | Drug: Miricorilant, Fluvoxamine | Antipsychotic Induced Weight Gain, Non-alcoholic Steatohepatitis (NASH) | 26 | 2023-01-24 | 2023-02-23actual | — | 2023-03-22 |
| REGN | Regeneron Pharmaceuticals | $76.1B | Genetic Data Collection in Adult Participants to Identify Genetic Variants of Known Importance in Non-alcoholic Steatohepatitis (NASH)NCT05423327Genotype frequencies of rs72613567 in Hydroxysteroid 17β dehydrogenase 13 (HSD17B13) | Not applicable | Terminatedsponsor's stated reason: Sponsor Decision | Procedure: No Intervention | Non-alcoholic Steatohepatitis (NASH) | 5,311 | 2021-12-09 | 2022-10-27actual | — | 2023-03-17 |
| MNOV | MediciNova | $66M | Open-Label Study To Evaluate MN-001 on HDL & Triglyceride in NASH & NAFLD SubjectsNCT02681055results2023-03-15Mean Change From Baseline at 12 Weeks of MN-001 Treatment on Cholesterol Efflux Capacity | Phase 2 | Completed | Drug: MN-001 | Non-alcoholic Steatohepatitis, Hypertriglyceridemia, Non-alcoholic Fatty Liver Disease, Hypercholesterolemia | 19 | Mar 2016 | 2018-05-30actual | — | 2023-03-15 |
| CYDY | CytoDyn, Inc. | $269M | Leronlimab (PRO 140) in Patients With Nonalcoholic SteatohepatitisNCT04521114results2023-03-01MRI-PDFF Change From Baseline to Week 14 | Phase 2 | Completed | Drug: Placebo, leronlimab 700 mg, leronlimab 350 mg | Nonalcoholic Steatohepatitis (NASH) | 87 | 2020-12-01 | 2021-12-29actual | — | 2023-03-01 |
| GNFT.PA | Genfit | $805M | Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)NCT01694849results2022-11-03Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) | Phase 2 | Completed | Drug: GFT505 80mg, GFT505 120mg, Placebo | Non-Alcoholic Steatohepatitis (NASH) | 275 | Sep 2012 | Feb 2015actual | — | 2022-11-03 |
| BMY | Bristol-Myers Squibb | $134.9B | A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver CirrhosisNCT03486912results2022-10-13The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48 | Phase 2 | Completed | Drug: BMS-986036 · Other: Placebo | Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis | 155 | 2018-06-12 | 2020-10-08actual | — | 2022-10-13 |
| GILD | Gilead Sciences | $177.9B | A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)NCT03551522results2022-07-05Percentage Change From Baseline in Magnetic Resonance Imaging-proton Density Fat Fraction (MRI-PDFF) | Phase 2 | Terminatedsponsor's stated reason: unexpected histological findings | Drug: Seladelpar, Placebos | NASH - Nonalcoholic Steatohepatitis | 181 | 2018-04-30 | 2019-05-08actual | — | 2022-09-15 |
| BMY | Bristol-Myers Squibb | $134.9B | A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver FibrosisNCT03486899results2022-09-09The Percentage of Participants With Improvement in Fibrosis or Nonalcoholic Steatohepatitis (NASH) at Week 24 | Phase 2 | Completed | Drug: BMS-986036 · Other: Placebo | Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis | 197 | 2018-06-19 | 2020-09-14actual | — | 2022-09-09 |
| CORT | Corcept Therapeutics | $12.8B | Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)NCT03823703results2022-08-31Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction | Phase 2 | Terminatedsponsor's stated reason: Suspended by sponsor, pending investigation of abnormal laboratory values in patients with NASH | Drug: Miricorilant, Placebo | Nonalcoholic Steatohepatitis (NASH) | 12 | 2020-11-04 | 2021-04-05actual | — | 2022-08-31 |
| HEPA | Hepion Pharmaceuticals, Inc. | $6M | A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 SubjectsNCT04480710results2022-07-15Number of Safety and Tolerability Events of CRV431 Versus Placebo. | Phase 2 | Completed | Drug: CRV431 75mg, Placebo (1 softgel), CRV431 225mg, Placebo (3 softgels) | NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver, NAFLD - Nonalcoholic Fatty Liver Disease | 47 | 2020-06-23 | 2021-06-29actual | — | 2022-07-15 |
| POXEL.PA | Poxel SA | $11M | Study to Assess the Safety, Tolerability, and Pharmacokinetics of PXL770 in Healthy Subjects.NCT05441904Cmax | Phase 1 | Completed | Drug: PXL770 | NASH - Nonalcoholic Steatohepatitis | 16 | 2021-03-08 | 2021-03-29actual | — | 2022-07-01 |
| PFE | Pfizer | $155.3B | A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes MellitusNCT03969719results2022-05-11Percent Change From Baseline in Whole Liver Fat at Week 16 | Phase 2 | Completed | Drug: Placebo, PF-06835919, PF-06835919 | Non-alcoholic Steatohepatitis | 164 | 2019-07-18 | 2021-03-02actual | — | 2022-05-11 |
| SNY | Sanofi | — | Assessment of the Safety and Effect of SAR425899 Versus Placebo for the Treatment of Non-alcoholic Fatty Liver DiseaseNCT03437720Resolution of Non-alcoholic steatohepatitis (NASH) | Phase 2 | Withdrawnsponsor's stated reason: Sponsor decision to cancel TRIAL, not related to safety concern. | Drug: SAR425899, Placebo | Non-alcoholic Steatohepatitis, Type 2 Diabetes Mellitus | 0 | 2019-05-23 | 2021-08-25 | — | 2022-04-13 |
| NVO | Novo Nordisk A/S | — | A Research Study Looking at How the Medicine NNC0194-0499 Behaves in Japanese and Non-Asian MenNCT04722653Number of treatment emergent adverse events (TEAEs) | Phase 1 | Completed | Drug: NNC0194-0499, Placebo (NNC0194-0499 ) | Non-alcoholic Steatohepatitis | 42 | 2021-02-02 | 2021-04-27actual | — | 2022-04-05 |
| GILD | Gilead Sciences | $177.9B | Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)NCT02781584results2022-02-02Percentage of Participants Who Experienced Treatment-Emergent Adverse Events | Phase 2 | Completed | Drug: SEL, FIR, CILO, FENO, VAS | Nonalcoholic Steatohepatitis (NASH), Nonalcoholic Fatty Liver Disease (NAFLD) | 220 | 2016-06-13 | 2020-12-17actual | — | 2022-03-16 |
| AZN | AstraZeneca | — | A Study to Understand the Safety, Tolerability, and Activity of Drug in Body Over a Period of Time of AZD2693, in Subjects of Non-Childbearing Potential in Overweight But Otherwise Healthy Subjects, and Healthy Chinese and Japanese SubjectsNCT04142424Number of subjects experiencing adverse events and serious adverse events | Phase 1 | Completed | Drug: AZD2693, Placebo | Metabolic Disorders, Non-alcoholic Steatohepatitis | 73 | 2019-10-28 | 2021-11-12actual | — | 2021-11-26 |
| NVO | Novo Nordisk A/S | — | Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.NCT02970942results2021-04-21Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) | Phase 2 | Completed | Drug: Semaglutide, Placebo | Hepatobiliary Disorders, Non-alcoholic Steatohepatitis | 320 | 2016-11-30 | 2020-02-13actual | — | 2021-11-16 |
| ENTA | Enanta Pharmaceuticals, Inc | $387M | A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic SteatohepatitisNCT03421431results2021-09-16Mean Change From Baseline (Average) in Alanine Aminotransferase (ALT) at Week 12 | Phase 2 | Completed | Drug: EDP-305 Dose 1, EDP-305 Dose 2, Placebo | Non-Alcoholic Steatohepatitis | 134 | 2018-04-25 | 2019-06-14actual | — | 2021-09-16 |
| GILD | Gilead Sciences | $177.9B | Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)NCT03987074results2021-07-15Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | Phase 2 | Completed | Drug: Semaglutide, Firsocostat, Cilofexor | Nonalcoholic Steatohepatitis | 109 | 2019-07-29 | 2020-07-13actual | — | 2021-07-15 |
| BMY | Bristol-Myers Squibb | $134.9B | A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)NCT02413372results2020-01-28Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | Phase 2 | Completed | Drug: BMS-986036, BMS-986036, Placebo | Non-Alcoholic Steatohepatitis | 184 | 2015-05-08 | 2017-01-18actual | — | 2021-02-26 |
| BMY | Bristol-Myers Squibb | $134.9B | A Sub-study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)NCT03400163results2020-02-19Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | Phase 2 | Completed | Drug: BMS-986036, Placebo | Non-Alcoholic Steatohepatitis | 3 | 2015-05-08 | 2017-01-18actual | — | 2021-02-26 |
| GILD | Gilead Sciences | $177.9B | Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic FunctionNCT02808312results2020-09-30Pharmacokinetic (PK) Parameter: AUClast of Cilofexor | Phase 1 | Completed | Drug: Cilofexor | Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC) | 57 | 2016-07-13 | 2018-10-16actual | — | 2021-01-07 |
| GILD | Gilead Sciences | $177.9B | Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic FunctionNCT02891408results2020-12-17Pharmacokinetic (PK) Parameter: AUClast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate) | Phase 1 | Completed | Drug: Firsocostat, Fenofibrate | Nonalcoholic Steatohepatitis (NASH) | 74 | 2016-09-23 | 2019-05-05actual | — | 2020-12-17 |
| PFE | Pfizer | $155.3B | Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)NCT03248882results2020-03-10Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16 | Phase 2 | Completed | Drug: Placebo, PF-05221304 | Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis | 305 | 2017-08-22 | 2019-02-26actual | — | 2020-12-09 |
| GILD | Gilead Sciences | $177.9B | Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)NCT03449446results2020-12-03Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | Phase 2 | Completed | Drug: SEL, FIR, CILO, Placebo to match FIR, Placebo to match CILO, Placebo to match SEL | Nonalcoholic Steatohepatitis | 395 | 2018-03-21 | 2019-10-30actual | — | 2020-12-03 |
| GILD | Gilead Sciences | $177.9B | Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and PharmacodynamicsNCT02654002results2020-10-12Single-Dose Pharmacokinetic (PK) Parameter: AUClast of Cilofexor | Phase 1 | Completed | Drug: Cilofexor, Placebo | Nonalcoholic Steatohepatitis (NASH) | 120 | 2016-01-20 | 2016-07-14actual | — | 2020-10-12 |
| GALT | Galectin Therapeutics Inc. | $355M | Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced FibrosisNCT02421094results2020-09-28Mean Change in Liver Fibrosis of Corrected T1 (cT1) Mapping (LiverMultiScan -LMS) | Phase 2 | Completed | Drug: GR-MD-02, Placebo | Nonalcoholic Steatohepatitis | 30 | Sep 2015 | 2016-09-27actual | — | 2020-10-08 |
| GILD | Gilead Sciences | $177.9B | Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic SteatohepatitisNCT02856555results2020-07-24Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Phase 2 | Completed | Drug: Firsocostat, Placebo | Nonalcoholic Steatohepatitis (NASH) | 127 | 2016-08-08 | 2017-07-18actual | — | 2020-07-24 |
| GILD | Gilead Sciences | $177.9B | Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) FibrosisNCT03053050results2020-06-29Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH at Week 48 | Phase 3 | Terminatedsponsor's stated reason: This study was terminated early due to lack of efficacy based on the results of the Week 48 analysis as prespecified in the clinical study protocol. | Drug: SEL, Placebo to match SEL 6 mg, Placebo to match SEL 18 mg | Nonalcoholic Steatohepatitis | 808 | 2017-02-13 | 2019-06-19actual | — | 2020-06-29 |
| GILD | Gilead Sciences | $177.9B | Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)NCT03053063results2020-05-07Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH | Phase 3 | Terminatedsponsor's stated reason: This study was terminated early due to lack of efficacy based on the results of the Week 48 analysis as prespecified in the clinical study protocol. | Drug: SEL, Placebo to match SEL 6 mg, Placebo to match SEL 18 mg | Nonalcoholic Steatohepatitis | 883 | 2017-01-30 | 2019-05-06actual | — | 2020-05-07 |
| BMY | Bristol-Myers Squibb | $134.9B | A Study of Experimental Medication BMS-986036 Given to Healthy ParticipantsNCT03445208Maximum observed serum concentration (Cmax) | Phase 1 | Completed | Drug: BMS-986036 | Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis | 30 | 2018-02-14 | 2018-05-02actual | — | 2020-03-19 |
| CANF | Can-Fite BioPharma | — | A Study of the Efficacy and Safety of CF102 in the Treatment of Non-Alcoholic Fatty Liver DiseaseNCT02927314Efficacy of CF102 as determined by change in serum alanine aminotransferase (ALT) levels | Phase 2 | Completed | Drug: CF102, Placebo | Non-alcoholic Steatohepatitis (NASH) | 60 | 2017-11-27 | 2020-03-01actual | — | 2020-03-17 |
| PFE | Pfizer | $155.3B | 2-Week Study In People With Nonalcoholic Fatty Liver DiseaseNCT03513588results2020-03-13Relative Change From Baseline in Whole Liver Fat at Day 15 as Assessed by Magnetic Resonance Imaging (MRI) - Proton Density Fat Fraction (PDFF) | Phase 1 | Completed | Drug: Placebo, PF-06865571, PF-06865571 | Non-alcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease | 48 | 2018-06-21 | 2019-03-08actual | — | 2020-03-13 |
| IMRN | Immuron Ltd. | — | A Phase ll Study of IMM-124E for Patients With Non-alcoholic SteatohepatitisNCT02316717results2020-02-21Safety Outcome Measure | Phase 2 | Completed | Biological: IMM-124E · Other: Placebo | Non-alcoholic Steatohepatitis (NASH) | 133 | Dec 2014 | 2017-10-30actual | — | 2020-02-21 |
| MIRM | Mirum Pharmaceuticals, Inc. | $6.5B | Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH)NCT02787304results2019-11-25Number of Subjects Achieving Binary Response on Liver Histology Between Volixibat (SHP626) and Placebo at Week 48 | Phase 2 | Terminated | Drug: SHP626, Placebo | Non-Alcoholic Steatohepatitis | 197 | 2016-10-24 | 2018-07-27actual | — | 2019-11-25 |
| BMY | Bristol-Myers Squibb | $134.9B | A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious PsoriasisNCT03329885results2019-10-21Number of Participants That Experienced the Following: Serious Adverse Events (SAEs), Death or an Adverse Event (AE) Leading to Study Discontinuation | Phase 1/2 | Terminatedsponsor's stated reason: Adverse change in the risk/benefit | Drug: BMS-986251 · Other: Placebo | Rheumatoid Arthritis, Psoriasis, Ankylosing Spondylitis, Inflammatory Bowel Diseases, Nonalcoholic Steatohepatitis | 38 | 2017-11-02 | 2018-06-26actual | — | 2019-10-21 |
| BMY | Bristol-Myers Squibb | $134.9B | An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney FunctionNCT03674476Maximum observed serum concentration (Cmax) of C-terminal intact BMS-986036 | Phase 1 | Completed | Drug: BMS-986036 | NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis | 40 | 2018-09-11 | 2019-06-24actual | — | 2019-10-08 |
| ENTA | Enanta Pharmaceuticals, Inc | $387M | A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female SubjectsNCT03783897Area under the plasma concentration-time (AUC0-τ) curve for OC with and without coadministration with EDP-305 | Phase 1 | Completed | Drug: EDP-305, Oral Contraceptive | NASH - Nonalcoholic Steatohepatitis | 43 | 2018-11-27 | 2019-06-04actual | — | 2019-07-24 |
| GILD | Gilead Sciences | $177.9B | Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3NCT02466516results2019-06-26Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality | Phase 2 | Completed | Drug: SEL · Biological: SIM | Non-Alcoholic Steatohepatitis (NASH) | 72 | 2015-06-08 | 2016-10-11actual | — | 2019-06-26 |
| MIRM | Mirum Pharmaceuticals, Inc. | $6.5B | A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One DoseNCT02571192Pharmacokinetic parameters will be determined from the plasma and blood concentration time data of total radioactivity and from the plasma concentration-time data for SHP626 by non-compartmental analysis. | Phase 1 | Completed | Drug: SHP626 · Radiation: 5.95 μCi RAD | Non-Alcoholic Steatohepatitis | 8 | 2015-10-01 | 2015-10-01actual | — | 2019-05-01 |
| GILD | Gilead Sciences | $177.9B | Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)NCT01672866results2019-03-27Change From Baseline in MQC on Liver Biopsy | Phase 2 | Terminated | Biological: Placebo, SIM | Liver Fibrosis Due to NASH | 222 | 2012-12-05 | 2016-08-02actual | — | 2019-03-27 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
How MASH / Nonalcoholic Steatohepatitis is matched — 12 exact registry spellings
A study is on this page when its ClinicalTrials.gov record names one of these conditions exactly (letter case aside). Nothing is matched by substring or stem, so a longer condition that merely contains one of these words is a different page. The list was curated by hand and last measured 2026-08-19; a spelling filed by only one study was not curated, so the counts here are a floor rather than the registry's own total for the disease.
- Nonalcoholic Steatohepatitis
- Nonalcoholic Steatohepatitis (NASH)
- Non-alcoholic Steatohepatitis
- NASH - Nonalcoholic Steatohepatitis
- NASH
- Non-alcoholic Steatohepatitis (NASH)
- MASH
- MASH - Metabolic Dysfunction-Associated Steatohepatitis
- Metabolic Dysfunction-Associated Steatohepatitis
- Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- NASH With Fibrosis
- Liver Fibrosis Due to NASH
Permalink · All conditions · Catalyst calendar · Every registered study · Search the whole pipeline for “MASH / Nonalcoholic Steatohepatitis” (a text search, wider than this page)