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Clinical trials
catalyst calendar across sponsors →Studies where RYTM 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.
25 interventional · 3 observational · 1 expanded access · 14 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)NCT07156578Safety and tolerability of bivamelagon as assessed by the number and frequency of AEsOpen-label · Treatment | Phase 2 | Enrolling by invitation | Drug: Bivamelagon | Hypothalamic Obesity | 25 | 2028-04-15 | in 605 d | 2026-02-10 |
| A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway ImpairmentNCT06239116Parts A, B, C, D: Safety and Tolerability Assessed by Number of Study Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Randomized · Triple-masked · Treatment | Phase 1/2 | Recruiting | Drug: Part A: RM-718 or placebo (matched to specific RM-718 dose cohort), Part B: RM-718 or placebo (matched to specific RM-718 dose cohort), Part C: RM-718, Part D: RM-718 | Hypothalamic Obesity, Prader-Willi Syndrome, PWS | 150 | 2027-11-01 | in 439 d | 2025-12-22 |
| A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)NCT06760546Mean % change in BMIRandomized · Triple-masked · Treatment | Phase 3 | Recruiting | Drug: Setmelanotide, Placebo | Hypothalamic Obesity, Multiple Pituitary Hormone Deficiency Genetic Form, Septo-Optic Dysplasia, Optic Nerve Hypoplasia, Childhood-onset Combined Pituitary Hormone Deficiency, Pituitary Stalk Interruption Syndrome | 39 | 2027-03-13 | in 206 d | 2026-02-12 |
| A Study of Setmelanotide in Patients With Prader-Willi SyndromeNCT06772597Frequency and severity of adverse events (AEs)Open-label · Treatment | Phase 2 | Active, not recruiting | Drug: Setmelanotide | Prader-Willi Syndrome, Obesity, Hyperphagia | 18 | 2026-10-31 | in 73 d | 2026-02-12 |
| A Trial of Setmelanotide in Acquired Hypothalamic ObesityNCT05774756results2026-05-29Pivotal Cohort: Mean Percent Change From Baseline in Body Mass Index (BMI) After 52 Weeks on a Therapeutic RegimenRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Active, not recruiting | Drug: Setmelanotide, Placebo | Hypothalamic Obesity | 143 | 2025-03-18actual | — | 2026-08-10 |
| Open-Label Extension Study of SetmelanotideNCT06596135Safety and tolerability of setmelanotide assessed by frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)Open-label · Treatment | Phase 3 | Completed | Drug: Setmelanotide | Obesity Associated With Defects in Leptin-melanocortin Pathway | 28 | 2026-06-24actual | — | 2026-07-15 |
| A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic ObesityNCT06046443Mean percentage change in BMIRandomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: LB54640, Placebo | Hypothalamic Obesity | 28 | 2026-02-09actual | — | 2026-02-12 |
| EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R PathwayNCT05093634Difference in mean change in body weight in patients treated with setmelanotide compared to placebo, assessed as percent change in BMIRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Setmelanotide, Placebo | Obesity, Genetic Obesity | 296 | 2025-12-22actual | — | 2026-08-06 |
| Long Term Extension Trial of SetmelanotideNCT03651765results2025-05-31Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Completed | Drug: Setmelanotide | Obesity Associated With Defects in Leptin-melanocortin Pathway | 205 | 2025-01-09actual | — | 2025-05-31 |
| Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R PathwayNCT05194124results2024-11-26Maximum Drug Concentration (Cmax) of Setmelanotide After QD Administration in the Run-in PeriodRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Setmelanotide 2 mg, Setmelanotide 2.5 mg, Setmelanotide 3 mg, Setmelanotide 20 mg, Setmelanotide 25 mg, Setmelanotide 30 mg | Bardet-Biedl Syndrome, POMC Deficiency | 19 | 2023-10-19actual | — | 2024-11-26 |
| Setmelanotide in Pediatric Participants With Rare Genetic Diseases of ObesityNCT04966741results2024-07-10Percentage of Participants With Greater Than or Equal to (≥) 0.2 Reduction of BMI Z-Score From Baseline to Week 52Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Setmelanotide | Bardet-Biedl Syndrome, POMC Deficiency Obesity, PCSK1 Deficiency Obesity, LEPR Deficiency Obesity | 12 | 2023-09-18actual | — | 2024-11-27 |
| DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) PathwayNCT04963231results2024-10-24Stage 1: Number of Participants by Genotype Who Demonstrated a Significant Clinically Meaningful Response to Setmelanotide at the End of Stage 1Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Setmelanotide, Placebo | Genetic Obesity | 164 | 2023-08-04actual | — | 2025-07-02 |
| Open-Label Study of Setmelanotide in Hypothalamic ObesityNCT04725240results2023-09-21Percentage of Participants With ≥ 5% Reduction in BMI From Baseline After 16 Weeks of Setmelanotide TreatmentOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Setmelanotide | Hypothalamic Obesity | 18 | 2022-06-28actual | — | 2025-02-07 |
| Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy ParticipantsNCT05046132results2024-05-03Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Setmelanotide, Moxifloxacin, Oral Placebo, SC Placebo | Healthy | 77 | 2022-04-07actual | — | 2024-05-03 |
| Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of ObesityNCT03013543results2023-08-18Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide TreatmentNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Setmelanotide | Genetic Obesity, Obesity, Obesity Due to Melanocortin 4 Receptor Deficiency | 213 | 2022-03-01actual | — | 2023-08-18 |
| A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal ImpairmentNCT04348175Pharmacokinetic Parameter - Peak Plasma Concentration (Cmax)Non-randomized · Open-label · Other | Phase 1 | Completed | Drug: Setmelanotide | Renal Insufficiency | 32 | 2021-04-17actual | — | 2021-06-30 |
| An Observational,Prospective Natural History Study of Early-Onset Extreme Obesity Due to Bi-Allelic Loss-of-Function Mutations in the POMC, PCSK1 or LEPR GenesNCT03621007observationalDemographics | — | Completed | — | POMC Deficiency Obesity, PCSK1 Deficiency Obesity, LEPR Deficiency Obesity | 8 | 2021-01-22actual | — | 2021-06-30 |
| The TEMPO (Tracing the Effect of the MC4 Pathway in Obesity) RegistryNCT03479437observationalAssessment of Quality of Life | — | Completed | — | Genetic Forms of Extreme Obesity | 303 | 2020-12-01actual | — | 2021-05-04 |
| Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe ObesityNCT03746522results2023-12-01Percentage of Participants (≥12 Years of Age at Baseline) Who Reached ≥10% Weight Loss Threshold After 1 Year (Period 2): Pivotal CohortRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Setmelanotide, Placebo | Bardet Biedl Syndrome (BBS), Alström Syndrome (AS) | 52 | 2020-11-16actual | — | 2023-12-01 |
| Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency ObesityNCT03287960results2023-05-23Percentage of Participants Who Reached ≥10% Weight Loss Threshold After 1 Year (Pivotal Cohort)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Setmelanotide, Placebo | Leptin Receptor Deficiency Obesity | 15 | 2020-09-25actual | — | 2023-05-23 |
| Genetic Testing and Phenotypic Characterization of Severely Obese Pediatric and Adult VolunteersNCT02849977observationalIdentification of individuals with POMC, LepR or PCSK1 genetic mutations | — | Completed | — | Pro-opiomelanocortin (POMC), Proprotein Convertase Subtilisin/Kexin Type 1 (PCSK1) and Leptin Receptor (LepR) Gene Mutations | 5,966 | 2020-06-09actual | — | 2022-11-15 |
| Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency ObesityNCT02896192results2023-09-21Percentage of Participants Who Reached ≥10% Weight Loss Threshold After 1 Year (Pivotal Cohort)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Setmelanotide, Placebo | Pro-opiomelanocortin (POMC) Deficiency Obesity | 15 | 2020-05-25actual | — | 2023-09-21 |
| Setmelanotide in a Single Patient With Partial LipodystrophyNCT03262610Fasting Triglycerides (TG) levelsOpen-label · Treatment | Phase 2 | Completed | Drug: Setmelanotide | Hypertriglyceridemia, Obesity | 1 | 2018-01-31actual | — | 2022-01-04 |
| Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi SyndromeNCT02311673results2023-07-27Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) - Period 2Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Setmelanotide, Placebo | Prader-Willi Syndrome | 40 | 2016-10-26actual | — | 2023-07-27 |
| Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese PatientsNCT02041195results2023-08-07Body Weight - Stage ARandomized · Double-masked · Treatment | Phase 1/2 | Completed | Drug: Setmelanotide, Placebo | Overweight and Obesity | 99 | Aug 2014actual | — | 2023-08-07 |
| Effects of RM-493 on Energy Expenditure in Obese IndividualsNCT01867437Resting energy expenditure measured in a room calorimeter during continuous subcutaneous infusion of RM-493 or placebo in obese healthy subjectsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Placebo, RM-493 | Obesity, Morbid Obesity | 15 | Mar 2014actual | — | 2017-04-20 |
| Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RM-493 Administered to Healthy, Obese, Non-diabetic VolunteersNCT02431442Number of adverse events.Randomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: RM-493, Placebo | Overweight, Obese | 57 | Jan 2014actual | — | 2015-05-01 |
| Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese ParticipantsNCT01749137results2023-08-14Percent Change From Baseline in Body WeightRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Setmelanotide, Placebo | Overweight | 74 | 2013-09-28actual | — | 2023-08-14 |
| An Expanded Access Protocol for Setmelanotide for Treatment of Bardet-Biedl Syndrome (BBS)NCT05183802expanded access | — | Approved for marketing | Drug: Setmelanotide, administered subcutaneously [SC], once daily. | Bardet-Biedl Syndrome (BBS), Obesity | — | — | — | 2022-08-10 |
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