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Showing 1–21 of 21 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Setmelanotide Clear all
Active, not recruiting Phase 2 Interventional

A Study of Setmelanotide in Patients With Prader-Willi Syndrome

NCT06772597
View directory record Official record
Conditions
Prader-Willi Syndrome, Obesity, Hyperphagia
Interventions
Setmelanotide
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
6 Years to 65 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
1
States / cities
Gainesville, Florida
Source: ClinicalTrials.gov public record
Updated Feb 11, 2026 · Synced Sep 5, 2026, 9:07 AM EDT
Completed Phase 3 Interventional Results available

Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity

NCT02896192
View directory record Official record
Conditions
Pro-opiomelanocortin (POMC) Deficiency Obesity
Interventions
Setmelanotide, Placebo
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
6 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
1
States / cities
Scottsdale, Arizona
Source: ClinicalTrials.gov public record
Updated Sep 20, 2023 · Synced Sep 5, 2026, 9:07 AM EDT
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 5, 2026, 9:07 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 5, 2026, 9:07 AM EDT
Active, not recruiting Phase 3 Interventional Results available

A Trial of Setmelanotide in Acquired Hypothalamic Obesity

NCT05774756
View directory record Official record
Conditions
Hypothalamic Obesity
Interventions
Setmelanotide, Placebo
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
4 Years and older
Enrollment
143 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
16
States / cities
Birmingham, Alabama • San Diego, California • Aurora, Colorado + 11 more
Source: ClinicalTrials.gov public record
Updated Aug 9, 2026 · Synced Sep 5, 2026, 9:07 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment

NCT04348175
View directory record Official record
Conditions
Renal Insufficiency
Interventions
Setmelanotide
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 83 Years
Enrollment
32 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2021
U.S. locations
4
States / cities
Miami, Florida • Orlando, Florida • Knoxville, Tennessee + 1 more
Source: ClinicalTrials.gov public record
Updated Jun 29, 2021 · Synced Sep 5, 2026, 9:07 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 5, 2026, 9:07 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 5, 2026, 9:07 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 5, 2026, 9:07 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Long Term Extension Trial of Setmelanotide

NCT03651765
View directory record Official record
Conditions
Obesity Associated With Defects in Leptin-melanocortin Pathway
Interventions
Setmelanotide
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
2 Years and older
Enrollment
205 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2025
U.S. locations
15
States / cities
Chandler, Arizona • Scottsdale, Arizona • San Diego, California + 12 more
Source: ClinicalTrials.gov public record
Updated May 30, 2025 · Synced Sep 5, 2026, 9:07 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients

NCT02041195
View directory record Official record
Conditions
Overweight and Obesity
Interventions
Setmelanotide, Placebo
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
99 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014
U.S. locations
2
States / cities
Dallas, Texas • Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Aug 6, 2023 · Synced Sep 5, 2026, 9:07 AM EDT
Completed Phase 2 Interventional

Setmelanotide in a Single Patient With Partial Lipodystrophy

NCT03262610
View directory record Official record
Conditions
Hypertriglyceridemia, Obesity
Interventions
Setmelanotide
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
15 Years to 15 Years · Female only
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
1
States / cities
Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Jan 3, 2022 · Synced Sep 5, 2026, 9:07 AM EDT
Completed Phase 3 Interventional

Open-Label Extension Study of Setmelanotide

NCT06596135
View directory record Official record
Conditions
Obesity Associated With Defects in Leptin-melanocortin Pathway
Interventions
Setmelanotide
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
2 Years and older
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
13
States / cities
Scottsdale, Arizona • San Diego, California • Gainesville, Florida + 10 more
Source: ClinicalTrials.gov public record
Updated Jul 14, 2026 · Synced Sep 5, 2026, 9:07 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 5, 2026, 9:07 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 5, 2026, 9:07 AM EDT
Completed Phase 3 Interventional

EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway

NCT05093634
View directory record Official record
Conditions
Obesity, Genetic Obesity
Interventions
Setmelanotide, Placebo
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
6 Years to 65 Years
Enrollment
296 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
32
States / cities
Phoenix, Arizona • Scottsdale, Arizona • Los Angeles, California + 26 more
Source: ClinicalTrials.gov public record
Updated Aug 5, 2026 · Synced Sep 5, 2026, 9:07 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 5, 2026, 9:07 AM EDT
Recruiting Phase 3 Interventional

A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)

NCT06760546
View directory record Official record
Conditions
Hypothalamic Obesity, Multiple Pituitary Hormone Deficiency Genetic Form, Septo-Optic Dysplasia, Optic Nerve Hypoplasia, Childhood-onset Combined Pituitary Hormone Deficiency, Pituitary Stalk Interruption Syndrome
Interventions
Setmelanotide, Placebo
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
4 Years and older
Enrollment
39 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
8
States / cities
Birmingham, Alabama • Aurora, Colorado • Chicago, Illinois + 5 more
Source: ClinicalTrials.gov public record
Updated Feb 11, 2026 · Synced Sep 5, 2026, 9:07 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 5, 2026, 9:07 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 5, 2026, 9:07 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 5, 2026, 9:07 AM EDT