Clinical trials
Every registered trial of Setmelanotide
29 studies, 3 still enrolling.
Plain-Language Summary
Plain-language reading of the public trial registries.
In short
- Setmelanotide has a real but limited body of human research.
- 29 registered studies in total.
- 3 are still enrolling people, so this is active research, not just history.
What kind of research
- 28 studies actually gave the peptide to volunteers and measured what happened. This is the kind of study that can show whether something works.
- About 1,933 people took part in those.
How far along it is
- 13 trials have reached phase 3 or 4 — the large, late-stage trials regulators rely on to approve a drug.
- 11 have published results in the medical literature that anyone can read.
- The research spans 14 countries.
A registered trial is a plan, not a result. Registration means a study was declared in advance; it says nothing about whether the peptide worked, and a trial can be registered and then abandoned.
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Showing 29 of 29 trials for Setmelanotide.
Setmelanotide to Treat Obesity in a Patient With Pseudohypoparathyroidism Type 1a (PHP1a)
Massachusetts General Hospital
Pseudohypoparathyroidism Type 1a · Obesity
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
Rhythm Pharmaceuticals, Inc.
Hypothalamic Obesity · Multiple Pituitary Hormone Deficiency Genetic Form · Septo-Optic Dysplasia · Optic Nerve Hypoplasia
SETmelanotide to improve hypothalamic function in the ROHHAD-syndrome; a proof of concept study in a small mono-center cohort: the ROH-SET Study
Universitair Medisch Centrum Utrecht
ROHHAD syndrome
A Study of Setmelanotide in Patients With Prader-Willi Syndrome
Rhythm Pharmaceuticals, Inc.
Prader-Willi Syndrome · Obesity · Hyperphagia
Open-Label Extension Study of Setmelanotide
Rhythm Pharmaceuticals, Inc.
Obesity Associated With Defects in Leptin-melanocortin Pathway
Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Obesity
University of California, Los Angeles
Dyspnea · Quality of Life
Named in the study description rather than as the headline intervention — often a drug given alongside the one being tested.
A Trial of Setmelanotide in Acquired Hypothalamic Obesity
Rhythm Pharmaceuticals, Inc.
Hypothalamic Obesity
Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity
Tom Hühne
Bardet Biedl Syndrome (BBS) · Bardet Biedl Syndrome · Bardet-Biedl Syndrome (BBS) · Alstrom Syndrome
RM-493-035
Rhythm Pharmaceuticals Inc.
Improper function of certain messenger materials in the body that control body weight and hunger in people
Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity
Rhythm Pharmaceuticals, Inc.
Bardet-Biedl Syndrome · POMC Deficiency Obesity · PCSK1 Deficiency Obesity · LEPR Deficiency Obesity
Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway
Rhythm Pharmaceuticals, Inc.
Bardet-Biedl Syndrome · POMC Deficiency
EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway
Rhythm Pharmaceuticals, Inc.
Obesity · Genetic Obesity
DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway
Rhythm Pharmaceuticals, Inc.
Genetic Obesity
Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants
Rhythm Pharmaceuticals, Inc.
Healthy
Open-Label Study of Setmelanotide in Hypothalamic Obesity
Rhythm Pharmaceuticals, Inc.
Hypothalamic Obesity
A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment
Rhythm Pharmaceuticals, Inc.
Renal Insufficiency
Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe Obesity
Rhythm Pharmaceuticals, Inc.
Bardet Biedl Syndrome (BBS) · Alström Syndrome (AS)
Long Term Extension Trial of Setmelanotide
Rhythm Pharmaceuticals, Inc.
Obesity Associated With Defects in Leptin-melanocortin Pathway
Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity
Rhythm Pharmaceuticals, Inc.
Leptin Receptor Deficiency Obesity
Setmelanotide in a Single Patient With Partial Lipodystrophy
Rhythm Pharmaceuticals, Inc.
Hypertriglyceridemia · Obesity
Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity
Rhythm Pharmaceuticals, Inc.
Pro-opiomelanocortin (POMC) Deficiency Obesity
Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity
Rhythm Pharmaceuticals, Inc.
Genetic Obesity · Obesity · Obesity Due to Melanocortin 4 Receptor Deficiency
Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome
Rhythm Pharmaceuticals, Inc.
Prader-Willi Syndrome
RM-493 Treatment Trial in Proopiomelanocortin (POMC) Deficient Patients
Charite University, Berlin, Germany
Homozygous or Compound Heterozygous POMC, LEPR or PCSK1 Gene Mutation
Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients
Rhythm Pharmaceuticals, Inc.
Overweight and Obesity
Effects of RM-493 on Energy Expenditure in Obese Individuals
Rhythm Pharmaceuticals, Inc.
Obesity · Morbid Obesity
Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants
Rhythm Pharmaceuticals, Inc.
Overweight
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RM-493 Administered to Healthy, Obese, Non-diabetic Volunteers
Rhythm Pharmaceuticals, Inc.
Overweight · Obese
- NCT05183802Approved For Marketing
An Expanded Access Protocol for Setmelanotide for Treatment of Bardet-Biedl Syndrome (BBS)
Rhythm Pharmaceuticals, Inc.
Bardet-Biedl Syndrome (BBS) · Obesity
Sources: ClinicalTrials.gov, the EU Clinical Trials Information System and ISRCTN, deduplicated so a study registered in more than one registry is counted once. A study is listed when Setmelanotide is named as an intervention. A registered trial is a plan, not a result — registration says nothing about whether the peptide worked.