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Rhythm Pharmaceuticals Advances Setmelanotide Study for Prader-Willi Syndrome

Rhythm Pharmaceuticals Advances Setmelanotide Study for Prader-Willi Syndrome

Rhythm Pharmaceuticals ((RYTM)) announced an update on their ongoing clinical study.

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Study Overview: Rhythm Pharmaceuticals is conducting a Phase 2 open-label study titled A Phase 2 Open-label Study of Setmelanotide in Patients With Prader-Willi Syndrome. The study aims to evaluate the safety and efficacy of setmelanotide in treating obesity due to Prader-Willi Syndrome (PWS) in patients aged 6 to 65. This research is significant as it addresses the unmet medical need for effective treatments for PWS-related obesity.

Intervention/Treatment: The intervention being tested is setmelanotide, a drug administered via daily subcutaneous injection. It is intended to manage obesity and hyperphagia in patients with Prader-Willi Syndrome.

Study Design: This interventional study follows a single-group assignment model with no masking, meaning all participants receive the treatment, and both researchers and participants know the treatment being administered. The primary purpose is treatment-focused.

Study Timeline: The study began on January 10, 2025, with the latest update submitted on October 13, 2025. These dates are crucial for tracking the progress and ensuring timely updates on the study’s findings.

Market Implications: The ongoing study could positively influence Rhythm Pharmaceuticals’ stock performance if results show setmelanotide to be effective, potentially enhancing investor sentiment. Success in this study may also position the company favorably against competitors in the obesity treatment market.

The study is currently recruiting, with further details available on the ClinicalTrials portal.

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