Rhythm Pharmaceuticals ((RYTM)) announced an update on their ongoing clinical study.
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Rhythm Pharmaceuticals is conducting a Phase 3 clinical trial titled A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity. The study aims to assess the effectiveness and safety of Setmelanotide in reducing weight, hunger, and improving the quality of life in patients aged 4 and older with congenital Hypothalamic Obesity (cHO).
The intervention being tested is Setmelanotide, a drug administered through daily subcutaneous injections. The purpose of the drug is to aid in weight reduction and manage hunger in patients with cHO.
The study is designed as a randomized, double-blind, placebo-controlled trial with a parallel intervention model. It features triple masking, ensuring that participants, care providers, and investigators are unaware of the treatment assignments. The primary goal is treatment efficacy.
The study began on December 31, 2024, with the primary completion date yet to be announced. The latest update was submitted on October 22, 2025, indicating ongoing recruitment and study progress.
The results of this study could significantly impact Rhythm Pharmaceuticals’ stock performance by demonstrating the efficacy of Setmelanotide, potentially boosting investor confidence. This development is crucial as the company competes in the obesity treatment market.
The study is currently ongoing, with further details available on the ClinicalTrials portal.