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Showing 1–11 of 11 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Setmelanotide 2 mg Clear all
Completed Phase 2 Interventional Results available

Open-Label Study of Setmelanotide in Hypothalamic Obesity

NCT04725240
View directory record Official record
Conditions
Hypothalamic Obesity
Interventions
Setmelanotide
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
6 Years to 40 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
5
States / cities
San Diego, California • Gainesville, Florida • Saint Paul, Minnesota + 2 more
Source: ClinicalTrials.gov public record
Updated Feb 6, 2025 · Synced Sep 6, 2026, 5:23 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Effects of RM-493 on Energy Expenditure in Obese Individuals

NCT01867437
View directory record Official record
Conditions
Obesity, Morbid Obesity
Interventions
Placebo, RM-493
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
15 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2014
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Apr 19, 2017 · Synced Sep 6, 2026, 5:23 AM EDT
Completed Phase 2 Interventional Results available

DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway

NCT04963231
View directory record Official record
Conditions
Genetic Obesity
Interventions
Setmelanotide, Placebo
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
6 Years to 65 Years
Enrollment
164 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
21
States / cities
Scottsdale, Arizona • Suwanee, Georgia • Worcester, Massachusetts + 16 more
Source: ClinicalTrials.gov public record
Updated Jul 1, 2025 · Synced Sep 6, 2026, 5:23 AM EDT
Completed Phase 3 Interventional Results available

Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe Obesity

NCT03746522
View directory record Official record
Conditions
Bardet Biedl Syndrome (BBS), Alström Syndrome (AS)
Interventions
Setmelanotide, Placebo
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
6 Years and older
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
6
States / cities
San Diego, California • Springfield, Massachusetts • New York, New York + 3 more
Source: ClinicalTrials.gov public record
Updated Nov 30, 2023 · Synced Sep 6, 2026, 5:23 AM EDT
Completed Phase 2 Interventional Results available

Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome

NCT02311673
View directory record Official record
Conditions
Prader-Willi Syndrome
Interventions
Setmelanotide, Placebo
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
16 Years to 65 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
5
States / cities
Irvine, California • Gainesville, Florida • Kansas City, Kansas + 2 more
Source: ClinicalTrials.gov public record
Updated Jul 26, 2023 · Synced Sep 6, 2026, 5:23 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers Results available

Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants

NCT05046132
View directory record Official record
Conditions
Healthy
Interventions
Setmelanotide, Moxifloxacin, Oral Placebo, SC Placebo
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
77 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2022
U.S. locations
1
States / cities
Glendale, California
Source: ClinicalTrials.gov public record
Updated May 2, 2024 · Synced Sep 6, 2026, 5:23 AM EDT
Completed Phase 3 Interventional Results available

Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway

NCT05194124
View directory record Official record
Conditions
Bardet-Biedl Syndrome, POMC Deficiency
Interventions
Setmelanotide 2 mg, Setmelanotide 2.5 mg, Setmelanotide 3 mg, Setmelanotide 20 mg, Setmelanotide 25 mg, Setmelanotide 30 mg
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
6 Years and older
Enrollment
19 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
2
States / cities
Scottsdale, Arizona • Marshfield, Wisconsin
Source: ClinicalTrials.gov public record
Updated Nov 25, 2024 · Synced Sep 6, 2026, 5:23 AM EDT
Completed Phase 2 Interventional Results available

Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity

NCT03013543
View directory record Official record
Conditions
Genetic Obesity, Obesity, Obesity Due to Melanocortin 4 Receptor Deficiency
Interventions
Setmelanotide
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
6 Years and older
Enrollment
213 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
43
States / cities
Birmingham, Alabama • Chandler, Arizona • Mesa, Arizona + 37 more
Source: ClinicalTrials.gov public record
Updated Aug 17, 2023 · Synced Sep 6, 2026, 5:23 AM EDT
Completed Phase 3 Interventional Results available

Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity

NCT04966741
View directory record Official record
Conditions
Bardet-Biedl Syndrome, POMC Deficiency Obesity, PCSK1 Deficiency Obesity, LEPR Deficiency Obesity
Interventions
Setmelanotide
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
2 Years to 5 Years
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
3
States / cities
Aurora, Colorado • New York, New York • Marshfield, Wisconsin
Source: ClinicalTrials.gov public record
Updated Nov 26, 2024 · Synced Sep 6, 2026, 5:23 AM EDT
Completed Phase 2 Interventional Results available

Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants

NCT01749137
View directory record Official record
Conditions
Overweight
Interventions
Setmelanotide, Placebo
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
74 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013
U.S. locations
6
States / cities
Miami, Florida • Lexington, Kentucky • Rochester, New York + 3 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2023 · Synced Sep 6, 2026, 5:23 AM EDT
Enrolling by invitation Phase 2 Interventional

Setmelanotide to Treat Obesity in a Patient With Pseudohypoparathyroidism Type 1a (PHP1a)

NCT07496463
View directory record Official record
Conditions
Pseudohypoparathyroidism Type 1a, Obesity
Interventions
Setmelanotide
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
Not listed
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jul 22, 2026 · Synced Sep 6, 2026, 5:23 AM EDT