Open-Label Study of Setmelanotide in Hypothalamic Obesity

Phase 2 Completed 18 enrolled Rhythm Pharmaceuticals, Inc.

NaSingle-groupOpen-labelTreatment

Summary

Open-label, single-arm study designed to evaluate the body weight response to setmelanotide administered subcutaneously (SC) daily in participants with hypothalamic obesity (HO).

Timeline

Start: 2021-06-07
Primary completion: 2022-06-28
Completion: 2022-06-28

Publications

Background Roth CL, Scimia C, Shoemaker AH, Gottschalk M, Miller J, Yuan G, Malhotra S, Abuzzahab MJ. Setmelanotide for the treatment of acquired hypothalamic obesity: a phase 2, open-label, multicentre trial. Lancet Diabetes Endocrinol. 2024 Jun;12(6):380-389. doi: 10.1016/S2213-8587(24)00087-1. Epub 2024 Apr 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Setmelanotide	Protein / enzyme biologic	3 mg	Subcutaneous

Open-Label Study of Setmelanotide in Hypothalamic Obesity

Summary

Timeline

Publications

Drugs

Indications