Setmelanotide

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under the skin · once daily

DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) PathwayPHASE2 · NCT04963231

“Participants ≥12 years of age started on setmelanotide 2.0 milligrams (mg) once daily for approximately 2 weeks, then increased to 3.0 mg once daily.”

3 mg

under the skin · once daily · for 16 weeks

Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of ObesityPHASE2 · NCT03013543

“All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD.”

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under the skin · once daily

Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi SyndromePHASE2 · NCT02311673

“Setmelanotide 0.5 mg.”

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under the skin · continuous infusion · for 14 days

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RM-493 Administered to Healthy, Obese, Non-diabetic VolunteersPHASE1 · NCT02431442

“Double-blind RM-493 will be administered at a dose of 0.01 mg/kg/24 hours via subcutaneous continuous infusion for 14 days (1 panel, all male subjects).”

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under the skin · once daily · for 14 weeks

Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe ObesityPHASE3 · NCT03746522

“Participants ≥16 years of age started on setmelanotide 2.0 mg with dose escalation to 3.0 mg.”

2 mg

under the skin

A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal ImpairmentPHASE1 · NCT04348175

“Setmelanotide will be administered as a single SC dose of 2.0 mg on Day 1.”

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under the skin · every 2 weeks · for 52 weeks

Setmelanotide in Pediatric Participants With Rare Genetic Diseases of ObesityPHASE3 · NCT04966741

“The dose was escalated by increments of 0.5 mg every 2 weeks, if tolerated, at the dose escalation visits (Weeks 2, 4, and 6) to a maximum dose of 0.5 to 2.0 mg QD with the maximum dose based on body weight.”

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under the skin · once daily

Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy ParticipantsPHASE4 · NCT05046132

“Group 1: Setmelanotide 2-7 mg + Placebo for Moxifloxacin.”

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daily

Setmelanotide to Treat Obesity in a Patient With Pseudohypoparathyroidism Type 1a (PHP1a)PHASE2 · NCT07496463

“Setmelanotide will be prescribed at the standard initial dose of 2 mg SC daily.”

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under the skin · once daily · for 1 week

Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R PathwayPHASE3 · NCT05194124

“Setmelanotide 2 mg.”

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mice · daily

The MC4R agonist, setmelanotide, is associated with an improvement in hypercapnic chemosensitivity and weight loss in male mice.Respiratory physiology & neurobiology · 2025

“We find that ten days of daily setmelanotide treatment at 1 mg/kg, but not 0.2 mg/kg, is sufficient to cause weight loss and increase HCVR.”