Trial Profile

A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 21 May 2025

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At a glance

14 May 2025 According to a Rhythm Pharmaceuticals media release, the Company remains on track to submit a supplemental New Drug Application to the FDA and a Type II variation request to the European Medicines Agency for setmelanotide for the treatment of patients with acquired HO in the third quarter of 2025.
14 May 2025 Results presented in the Rhythm Pharmaceuticals Media Release
14 May 2025 Primary endpoint has been met. (Mean % change in BMI)

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