GLP-1 Market
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About this data Sourced primarily from ClinicalTrials.gov — a listing isn't proof of safety or FDA approval.

Pipeline and clinical trial information here comes primarily from ClinicalTrials.gov. A listing on ClinicalTrials.gov means a study has been registered — not that a treatment is proven safe, effective, or FDA-approved. Investigational treatments may never be approved. Who can join a trial is decided only by that trial's own study team.

Not yet reported

Setmelanotide

Company
Rhythm Pharmaceuticals, Inc.
Mechanism
Mechanism not yet reported
Route
Route not yet reported
Recruiting trials
2 recruiting

Efficacy results: Not yet reported

Find a Clinical Trial Near Me

2 recruiting studies currently listed on ClinicalTrials.gov.

Data source: ClinicalTrials.gov · trial data as of Nov 13, 2026

Find a Clinical Trial Near Me

See recruiting studies for Setmelanotide and check eligibility with the study team.

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Treatment type

"Added to GLP-1" means the investigational treatment is being studied on top of an existing GLP-1-based therapy.

Your ZIP code is only used to calculate distance to trial sites — it isn't stored.

Trial details
  • Recruiting NCT NCT06760546

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

    Not yet reported Rhythm Pharmaceuticals, Inc. 39 participants Est. completion 2028-03-13 11 sites Stand-alone
    Other 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
    View official trial listing →
  • Recruiting NCT NCT07674290

    Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity

    Not yet reported Tom Hühne 200 participants Est. completion 2030-12-31 1 site Stand-alone
    Other conditions: Bardet Biedl Syndrome (BBS), Bardet Biedl Syndrome, Bardet-Biedl Syndrome (BBS), Alstrom Syndrome
    View official trial listing →
  • Completed NCT NCT01749137

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

    Not yet reported Rhythm Pharmaceuticals, Inc. 74 participants Est. completion 2013-09-28 6 sites Stand-alone
    Other conditions: Overweight
    View official trial listing →
  • Completed NCT NCT01867437

    Effects of RM-493 on Energy Expenditure in Obese Individuals

    Not yet reported Rhythm Pharmaceuticals, Inc. 15 participants Est. completion 2014-03 1 site
    Other conditions: Obesity, Morbid Obesity
    View official trial listing →
  • Completed NCT NCT02041195

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

    Not yet reported, Not yet reported Rhythm Pharmaceuticals, Inc. 99 participants Est. completion 2014-12 2 sites
    Other conditions: Overweight and Obesity
    View official trial listing →
  • Completed NCT NCT02311673

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

    Not yet reported Rhythm Pharmaceuticals, Inc. 40 participants Est. completion 2016-10-26 5 sites Stand-alone
    Other conditions: Prader-Willi Syndrome
    View official trial listing →
  • Completed NCT NCT02431442

    Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RM-493 Administered to Healthy, Obese, Non-diabetic Volunteers

    Not yet reported Rhythm Pharmaceuticals, Inc. 57 participants Est. completion 2014-01
    Other conditions: Overweight, Obese
    View official trial listing →
  • Status unknown NCT NCT02507492

    RM-493 Treatment Trial in Proopiomelanocortin (POMC) Deficient Patients

    Not yet reported Charite University, Berlin, Germany 10 participants Est. completion 2018-07 1 site
    Other conditions: Homozygous or Compound Heterozygous POMC, LEPR or PCSK1 Gene Mutation
    View official trial listing →
  • Completed NCT NCT02896192

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

    Not yet reported Rhythm Pharmaceuticals, Inc. 15 participants Est. completion 2020-05-25 7 sites Stand-alone
    Other conditions: Pro-opiomelanocortin (POMC) Deficiency Obesity
    View official trial listing →
  • Completed NCT NCT03013543

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

    Not yet reported Rhythm Pharmaceuticals, Inc. 213 participants Est. completion 2022-03-01 58 sites Stand-alone
    Other conditions: Genetic Obesity, Obesity, Obesity Due to Melanocortin 4 Receptor Deficiency
    View official trial listing →
  • Completed NCT NCT03262610

    Setmelanotide in a Single Patient With Partial Lipodystrophy

    Not yet reported Rhythm Pharmaceuticals, Inc. 1 participants Est. completion 2018-01-31 1 site Stand-alone
    Other conditions: Hypertriglyceridemia, Obesity
    View official trial listing →
  • Completed NCT NCT03287960

    Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity

    Not yet reported Rhythm Pharmaceuticals, Inc. 15 participants Est. completion 2020-09-25 6 sites Stand-alone
    Other conditions: Leptin Receptor Deficiency Obesity
    View official trial listing →
  • Completed NCT NCT03651765

    Long Term Extension Trial of Setmelanotide

    Not yet reported, Not yet reported Rhythm Pharmaceuticals, Inc. 205 participants Est. completion 2025-01-09 27 sites Stand-alone
    Other conditions: Obesity Associated With Defects in Leptin-melanocortin Pathway
    View official trial listing →
  • Completed NCT NCT03746522

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

    Not yet reported Rhythm Pharmaceuticals, Inc. 52 participants Est. completion 2021-03-08 12 sites Stand-alone
    Other conditions: Bardet Biedl Syndrome (BBS), Alström Syndrome (AS)
    View official trial listing →
  • Completed NCT NCT04348175

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

    Not yet reported Rhythm Pharmaceuticals, Inc. 32 participants Est. completion 2021-04-17 4 sites Stand-alone
    Other conditions: Renal Insufficiency
    View official trial listing →
  • Completed NCT NCT04725240

    Open-Label Study of Setmelanotide in Hypothalamic Obesity

    Not yet reported Rhythm Pharmaceuticals, Inc. 18 participants Est. completion 2022-06-28 5 sites Stand-alone
    Other conditions: Hypothalamic Obesity
    View official trial listing →
  • Completed NCT NCT04963231

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

    Not yet reported Rhythm Pharmaceuticals, Inc. 164 participants Est. completion 2024-09-30 36 sites Stand-alone
    Other conditions: Genetic Obesity
    View official trial listing →
  • Completed NCT NCT04966741

    Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity

    Not yet reported Rhythm Pharmaceuticals, Inc. 12 participants Est. completion 2024-11-08 6 sites Stand-alone
    Other conditions: Bardet-Biedl Syndrome, POMC Deficiency Obesity, PCSK1 Deficiency Obesity, LEPR Deficiency Obesity
    View official trial listing →
  • Completed NCT NCT05046132

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

    Not yet reported Rhythm Pharmaceuticals, Inc. 77 participants Est. completion 2022-04-07 1 site Stand-alone
    Other conditions: Healthy
    View official trial listing →
  • Completed NCT NCT05093634

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

    Not yet reported Rhythm Pharmaceuticals, Inc. 296 participants Est. completion 2026-06-30 66 sites Stand-alone
    Other conditions: Obesity, Genetic Obesity
    View official trial listing →
  • Approved For Marketing NCT NCT05183802

    An Expanded Access Protocol for Setmelanotide for Treatment of Bardet-Biedl Syndrome (BBS)

    Rhythm Pharmaceuticals, Inc.
    Other conditions: Bardet-Biedl Syndrome (BBS), Obesity
    View official trial listing →
  • Completed NCT NCT05194124

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

    Not yet reported Rhythm Pharmaceuticals, Inc. 19 participants Est. completion 2023-10-19 7 sites Stand-alone
    Other conditions: Bardet-Biedl Syndrome, POMC Deficiency
    View official trial listing →
  • Active, not recruiting NCT NCT05774756

    A Trial of Setmelanotide in Acquired Hypothalamic Obesity

    Not yet reported Rhythm Pharmaceuticals, Inc. 143 participants Est. completion 2027-04-16 28 sites Stand-alone
    Other conditions: Hypothalamic Obesity
    View official trial listing →
  • Withdrawn NCT NCT05812183

    Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Obesity

    Not yet reported University of California, Los Angeles Est. completion 2025-02-12 Stand-alone
    Other conditions: Dyspnea, Quality of Life
    View official trial listing →
  • Completed NCT NCT06596135

    Open-Label Extension Study of Setmelanotide

    Not yet reported Rhythm Pharmaceuticals, Inc. 28 participants Est. completion 2026-06-24 13 sites Stand-alone
    Other conditions: Obesity Associated With Defects in Leptin-melanocortin Pathway
    View official trial listing →
  • Active, not recruiting NCT NCT06772597

    A Study of Setmelanotide in Patients With Prader-Willi Syndrome

    Not yet reported Rhythm Pharmaceuticals, Inc. 18 participants Est. completion 2027-10-31 1 site Stand-alone
    Other conditions: Prader-Willi Syndrome, Obesity, Hyperphagia
    View official trial listing →
  • Enrolling by invitation NCT NCT07496463

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

    Not yet reported Massachusetts General Hospital 1 participants Est. completion 2027-04-30 1 site
    Other conditions: Pseudohypoparathyroidism Type 1a, Obesity
    View official trial listing →
Efficacy history

Not yet reported.

Safety

Not yet reported.

Sources

Also known as: Setmelanotide, Imcivree

Related On The Pen coverage

No related coverage yet.

This drug may be investigational and not yet approved for any use. Whether someone can join a clinical trial is determined only by that trial's own study team — On The Pen does not determine eligibility. Information here can change; always confirm current details on the official ClinicalTrials.gov listing or with the sponsor.