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Clinical trials
catalyst calendar across sponsors →Studies where ARWR is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
48 interventional · 1 expanded access · 20 with posted results
Held by 16 tracked-famous managers (Holocene Advisors, LP, SUSQUEHANNA INTERNATIONAL GROUP, LLP, TWO SIGMA INVESTMENTS, LP, Balyasny Asset Management L.P., RENAISSANCE TECHNOLOGIES LLC, +11 more) · FINRA short interest 3.9 days to cover (settled 2026-07-31) · government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute PancreatitisNCT06880770Time to First Occurrence of Positively Adjudicated AP Event (Event Occurring More Than 10 Days After First Dose of Study Drug)Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Plozasiran, Placebo | Severe Hypertriglyceridemia | 288 | Mar 2029 | ≤ 955 d | 2026-07-23 |
| Long-Term Safety and Efficacy of Plozasiran in Adults With HypertriglyceridemiaNCT06822790Number of Participants with Treatment-Emergent Adverse Events (TEAEs)Open-label · Treatment | Phase 3 | Recruiting | Drug: Plozasiran Injection | Hypertriglyceridemia | 869 | Jul 2028 | ≤ 712 d | 2026-08-12 |
| Study of Zodasiran in Adolescent Participants With Homozygous Familial HypercholesterolemiaNCT07473843Percent Change from Baseline to Month 12 in Fasting LDL-COpen-label · Treatment | Phase 3 | Not yet recruiting | Drug: Zodasiran | Homozygous Familial Hypercholesterolemia | 12 | Jul 2028 | ≤ 712 d | 2026-05-29 |
| Study of Inhaled ARO-RAGE in Allergen-induced Mild AsthmaNCT07241546Change from Baseline Over Time in Maximum Area of ReactanceRandomized · Triple-masked · Treatment | Phase 2 | Recruiting | Drug: ARO-RAGE, Placebo | Asthma | 36 | Dec 2027 | ≤ 499 d | 2026-06-23 |
| A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes MellitusNCT06700538Number of Participants with Treatment-Emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · Treatment | Phase 1/2 | Recruiting | Drug: ARO-INHBE, Placebo, Tirzepatide | Obesity | 180 | 2027-09-17 | in 394 d | 2026-08-18 |
| A Phase 3 Study of Zodasiran in Adolescent and Adult Subjects With Homozygous Familial Hypercholesterolemia (YOSEMITE)NCT07037771Percent Change from Baseline to Month 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) (Randomized period)Randomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: zodasiran Injection, Placebo | Homozygous Familial Hypercholesterolemia | 70 | 2027-08-20 | in 366 d | 2026-08-12 |
| A First-In-Human Study of ARO-033 in Adult ParticipantsNCT07662096Number of Participants With Treatment-emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Recruiting | Drug: ARO-033, Placebo | Healthy Participants | 42 | 2027-07-18 | in 333 d | 2026-07-22 |
| Study of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's DiseaseNCT07221344Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Over TimeRandomized · Quadruple-masked · Treatment | Phase 1/2 | Recruiting | Drug: ARO-MAPT-SC, Placebo | Alzheimer Disease, Alzheimer Disease, Early Onset | 112 | Jun 2027 | ≤ 315 d | 2026-06-23 |
| A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes MellitusNCT06937203Number of Participants with Treatment-Emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · Treatment | Phase 1/2 | Recruiting | Drug: ARO-ALK7, Placebo | Obesity, Diabetes Mellitus, Type 2 | 150 | Feb 2027 | ≤ 193 d | 2026-07-08 |
| Study of ARO-ATXN2 Injection in Adults With Spinocerebellar Ataxia Type 2NCT06672445Number of Participants with Treatment -Emergent Adverse Events (TEAEs) Over TimeRandomized · Quadruple-masked · Treatment | Phase 1 | Active, not recruiting | Drug: ARO-ATXN2 Injection, Placebo | Spinocerebellar Ataxia Type 2 | 39 | Dec 2026 | ≤ 134 d | 2026-06-29 |
| Study of ARO-DIMERPA in Adult Participants With Mixed HyperlipidemiaNCT07223658Number of Participants with Treatment-Emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · Treatment | Phase 1/2 | Recruiting | Drug: ARO-DIMERPA, Placebo | Hyperlipidemia; Mixed | 78 | 2026-09-30 | in 42 d | 2026-08-18 |
| Study of Plozasiran in Adults With Severe HypertriglyceridemiaNCT06347016Percent change in fasting serum TG levels from baseline to Month 12 compared to placeboRandomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Plozasiran Injection, Placebo | Severe Hypertriglyceridemia | 311 | 2026-06-17actual | — | 2026-08-06 |
| Study of Plozasiran (ARO-APOC3) in Adults With Severe HypertriglyceridemiaNCT06347003Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to PlaceboRandomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Plozasiran Injection, Placebo | Severe Hypertriglyceridemia | 446 | 2026-06-12actual | — | 2026-07-15 |
| Phase 3 Study of Plozasiran in Adults With HypertriglyceridemiaNCT06347133Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to PlaceboRandomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Plozasiran Injection, Placebo | Hypertriglyceridemia | 1,456 | 2026-06-01actual | — | 2026-06-26 |
| Study of ARO-APOC3 in Adults With DyslipidemiaNCT05413135Number of Participants with Treatment-Emergent Adverse Events (TEAEs)Open-label · Treatment | Phase 2 | Completed | Drug: ARO-APOC3 | Dyslipidemias | 418 | 2025-09-22actual | — | 2026-05-12 |
| Study of ARO-C3 in Adult Healthy Volunteers and Patients With Complement Mediated Renal DiseaseNCT05083364Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) at Day 169Randomized · Quadruple-masked · Treatment | Phase 1/2 | Completed | Drug: ARO-C3, Placebo | C3 Glomerulopathy, IgA Nephropathy | 62 | 2025-09-10actual | — | 2026-05-22 |
| Study of ARO-MMP7 Inhalation Solution in Healthy Participants and Participants With Idiopathic Pulmonary FibrosisNCT05537025results2026-08-05Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: ARO-MMP7 Inhalation Solution, Placebo | Idiopathic Pulmonary Fibrosis | 105 | 2025-09-05actual | — | 2026-08-05 |
| Study of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung DiseaseNCT05276570Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Randomized · Triple-masked · Treatment | Phase 1/2 | Completed | Drug: ARO-RAGE, Placebo | Asthma | 127 | 2025-04-16actual | — | 2026-04-09 |
| Study of AROSOD-1 in Adult Participants With Amyotrophic Lateral Sclerosis (ALS)NCT05949294Number of Participants with Treatment-Emergent Adverse Events (TEAEs)Open-label · Treatment | Phase 1 | Withdrawnsponsor's stated reason: Company business decision | Drug: ARO-SOD1 Injection | Amyotrophic Lateral Sclerosis | 0 | Mar 2025 | — | 2024-04-17 |
| Study of ARO-CFB in Adult Healthy VolunteersNCT06209177Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: ARO-CFB, Placebo | IgA Nephropathy | 49 | 2025-03-31actual | — | 2026-05-20 |
| Study of ARO-MUC5AC in Healthy Subjects and Patients With Muco-Obstructive Lung DiseaseNCT05292950Number of Participants with Treatment-Emergent Adverse Events (TEAEs)Randomized · Triple-masked · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: Sponsor business decision | Drug: ARO-MUC5AC, Placebo | Asthma, Chronic Obstructive Pulmonary Disease | 78 | 2024-11-12actual | — | 2025-11-05 |
| Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)NCT05089084results2026-02-04Percent Change From Baseline at Month 10 in Fasting Triglycerides (TG)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Plozasiran, Placebo | Familial Chylomicronemia | 75 | 2024-04-29actual | — | 2026-06-05 |
| Study of ARO-RAGE in Healthy SubjectsNCT05533294Number of Participants with Treatment-Emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: ARO-RAGE Injection, Placebo | Asthma | 43 | 2024-02-08actual | — | 2024-03-29 |
| Study of ARO-ANG3 in Participants With Homozygous Familial Hypercholesterolemia (HOFH)NCT05217667results2026-05-22Percent Change From Baseline in Fasting LDL-C at Week 24Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Business decision, unrelated to safety concerns. | Drug: ARO-ANG 3 Injection | Homozygous Familial Hypercholesterolemia | 18 | 2023-05-02actual | — | 2026-06-12 |
| Study to Evaluate ARO-APOC3 in Adults With Severe HypertriglyceridemiaNCT04720534results2026-03-24Percent Change From Baseline at Week 24 in Fasting Triglycerides (TG)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ARO-APOC3, Placebo | Severe Hypertriglyceridemia | 229 | 2023-03-09actual | — | 2026-03-24 |
| Study of Plozasiran (ARO-APOC3) in Adults With Mixed DyslipidemiaNCT04998201results2026-02-24Percent Change From Baseline at Week 24 in Fasting TGRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ARO-APOC3, Placebo | Mixed Dyslipidemia | 353 | 2023-02-10actual | — | 2026-04-14 |
| Study of ARO-ANG3 in Adults With Mixed DyslipidemiaNCT04832971results2024-01-16Percent Change From Baseline in Fasting TG at Week 24Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ARO-ANG3, Placebo | Mixed Dyslipidemia | 204 | 2022-08-30actual | — | 2025-12-03 |
| Study of Fazirsiran (TAK-999, ARO-AAT) in Patients With Alpha-1 Antitrypsin Deficiency Associated Liver Disease (AATD)NCT03946449results2025-04-20Percent Change From Baseline in Total Liver Z-AAT, Insoluble Liver-ZAAT, and Soluble Liver Z-AAT at Week 24: Cohorts 1/1bNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ARO-AAT | Alpha 1-Antitrypsin Deficiency | 16 | 2022-04-28actual | — | 2025-10-15 |
| Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell CarcinomaNCT04169711Number of Participants with Adverse Events (AEs) Possibly or Probably Related to TreatmentOpen-label · Treatment | Phase 1 | Completed | Drug: ARO-HIF2 | Clear Cell Renal Cell Carcinoma | 26 | 2022-01-24actual | — | 2025-10-09 |
| Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT)NCT03945292results2024-12-30Percent Change From Baseline in Serum Z-Alpha-1 Antitrypsin (Z-AAT) at Week 16Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Fazisiran Injection · Other: Placebo | Alpha 1-Antitrypsin Deficiency | 40 | 2021-11-08actual | — | 2025-11-04 |
| 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 TreatmentRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: ARO-HSD Injection, sterile normal saline (0.9% NaCl) | Non-alcoholic Steatohepatitis | 50 | 2021-09-03actual | — | 2025-10-03 |
| Study of ARO-ANG3 in Healthy Volunteers and in Dyslipidemic PatientsNCT03747224Number of Participants with Adverse Events (AEs) Possibly or Probably Related to TreatmentRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: ARO-ANG3, sterile normal saline (0.9% NaCl) | Dyslipidemias, Familial Hypercholesterolemia, Hypertriglyceridemia | 93 | 2021-05-17actual | — | 2025-12-24 |
| Study of ARO-ENaC in Healthy Volunteers and in Patients With Cystic FibrosisNCT04375514results2025-12-17Number of Participants With Adverse Events (AEs)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Terminatedsponsor's stated reason: Business decision | Drug: ARO-ENaC, Placebo | Cystic Fibrosis, Pulmonary | 43 | 2021-05-09actual | — | 2025-12-17 |
| Study of ARO-APOC3 in Healthy Volunteers, Hypertriglyceridemic Patients and Patients With Familial Chylomicronemia Syndrome (FCS)NCT03783377Number of Participants with Adverse Events (AEs) Possibly or Probably Related to TreatmentRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: ARO-APOC3, sterile normal saline (0.9% NaCl) | Hypertriglyceridemia, Familial Chylomicronemia | 112 | 2021-02-11actual | — | 2025-12-24 |
| Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)NCT03365947results2024-06-04Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to TreatmentRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: ARO-HBV, JNJ-56136379 · Other: Sterile Normal Saline (0.9% NaCl) | Hepatitis B | 114 | 2020-04-23actual | — | 2025-10-22 |
| Study of ARO-AAT in Normal Adult VolunteersNCT03362242Number of Participants With Adverse Events (AEs) Possibly or Probably Related to TreatmentRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: ARO-AAT Injection · Other: Sterile Normal Saline (0.9% NaCl) | Alpha 1-Antitrypsin Deficiency | 45 | 2018-10-23actual | — | 2025-12-24 |
| A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) InfectionNCT02065336results2019-07-05Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)Randomized · Triple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Company decision to discontinue trial | Drug: ARC-520, Placebo, entecavir, chlorpheniramine | Hepatitis B, Chronic | 58 | Jan 2017actual | — | 2026-01-13 |
| A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) InfectionNCT02604199results2019-04-16Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113Randomized · Quadruple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Company decision to discontinue trial | Drug: ARC-520 Injection, entecavir, tenofovir, antihistamine · Other: placebo | Hepatitis B | 58 | Jan 2017actual | — | 2026-01-13 |
| Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B VirusNCT02452528results2017-11-01Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 85Randomized · Triple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Company decision to discontinue trial | Drug: ARC-520, Placebo, Entecavir, Tenofovir, diphenhydramine | Chronic Hepatitis B | 4 | Dec 2016actual | — | 2025-11-03 |
| Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)NCT02577029results2019-04-12Percentage of Participants Achieving a 1-log Reduction in Hepatitis B Surface Antigen (HBsAg) at Week 60 Compared to BaselineNon-randomized · Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Company decision to discontinue trial | Drug: ARC-520, entecavir, tenofovir disoproxil, antihistamine · Biological: pegylated interferon alpha 2a | Hepatitis B, Hepatitis D | 79 | Dec 2016actual | — | 2026-01-13 |
| A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus InfectionNCT02604212results2019-04-16Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113Randomized · Quadruple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Company decision to discontinue trial | Drug: ARC-520, entecavir, antihistamine, tenofovir · Other: Placebo | Hepatitis B | 32 | Dec 2016actual | — | 2026-01-13 |
| Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) InfectionNCT02738008results2019-04-16Percentage of Initial Responders to ARC-520 Therapy Achieving a 1-log Reduction in HBsAg at Week 36 Compared to BaselineOpen-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Company decision to discontinue trial | Drug: ARC-520 Injection, entecavir, tenofovir, antihistamine | Hepatitis B | 12 | Dec 2016actual | — | 2026-01-13 |
| A Study of ARC-AAT in Healthy Volunteer Subjects and Patients With Alpha-1 Antitrypsin Deficiency (AATD)NCT02363946results2018-08-03Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Discontinuations Due to TEAEsRandomized · Triple-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: Company decision to terminate the trial | Drug: ARC-AAT Injection, Diphenhydramine · Other: Placebo | Alpha-1 Antitrypsin Deficiency | 65 | Nov 2016actual | — | 2026-01-12 |
| A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)NCT02797522results2018-09-25Number of Participants With Treatment-Emergent Adverse Events (TEAEs): Healthy VolunteersRandomized · Quadruple-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: Company decision to discontinue trial | Drug: ARC-521 Injection, antihistamine, acetaminophen, entecavir, tenofovir · Other: Placebo | Hepatitis B | 47 | Nov 2016actual | — | 2026-01-12 |
| Safety, Tolerability and Effect of ARC-AAT Injection on Circulating and Intrahepatic Alpha-1 Antitrypsin LevelsNCT02900183Incidence and frequency of adverse events as a measure of safety and tolerability of multiple doses of ARC-AAT InjectionOpen-label · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Company decision to not initiate trial | Drug: ARC-AAT Injection | Alpha-1 Antitrypsin Deficiency | 0 | Nov 2016actual | — | 2025-12-18 |
| A Study of ARC-520 at Varying Infusion Rates in Healthy Adult VolunteersNCT02535416results2018-02-26Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: ARC-520, cetirizine, diphenhydramine | Healthy | 40 | Aug 2016actual | — | 2026-01-13 |
| Study of ARC-520 in Patient With Chronic Hepatitis B VirusNCT02349126Efficacy: To evaluate the depth and duration of HBsAg decline in response to a single dose of ARC 520 in combination with entecavir or tenofovir in patients with chronic HBV infectionOpen-label · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Company decision to pursue alternative clinical trial | Drug: ARC-520 Injection | Chronic Hepatitis B | 0 | Dec 2015 | — | 2025-12-26 |
| Safety and Tolerability Study of ARC-520 in Healthy VolunteersNCT01872065To determine the incidence and frequency of adverse events as a measure of safety and tolerability of ARC-520Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: ARC-520, Placebo | Healthy | 54 | Sep 2014actual | — | 2025-12-26 |
| Treatment Protocol of Plozasiran in Adults With High-Risk Severe Hypertriglyceridemia (SHTG) and in Adults and Adolescents With FCSNCT06796426expanded access | — | Available | Drug: Plozasiran | Familial Chylomicronemia, High Risk Severe Hypertriglyceridemia (SHTG) | — | — | — | 2026-03-03 |
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.
Source: ClinicalTrials.gov, retrieved 2026-08-19