drugset
drugset / Trial / NCT05194124

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

NCT05194124 ↗

Phase 3 Completed 19 enrolled Rhythm Pharmaceuticals, Inc.
RandomizedCrossoverTriple-blindTreatment

Summary

A trial to compare the weekly and daily formulations of setmelanotide in participants with genetic defects in the melanocortin-4 receptor pathway.

Timeline

Start
2021-12-21
Primary completion
2023-10-19
Completion
2023-10-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Setmelanotide Protein / enzyme biologic 2 mg Subcutaneous
Subject Setmelanotide Protein / enzyme biologic 2.5 mg Subcutaneous
Subject Setmelanotide Protein / enzyme biologic 3 mg Subcutaneous
Subject Setmelanotide Protein / enzyme biologic 20 mg Subcutaneous
Subject Setmelanotide Protein / enzyme biologic 25 mg Subcutaneous
Subject Setmelanotide Protein / enzyme biologic 30 mg Subcutaneous

Indications

Bardet-Biedl syndrome obesity due to pro-opiomelanocortin deficiency