Rhythm Pharmaceuticals ((RYTM)) announced an update on their ongoing clinical study.
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Study Overview: Rhythm Pharmaceuticals is conducting an open-label extension study titled ‘Open-Label Extension Study of Setmelanotide in Patients With a Rare Genetic, Syndromic or Acquired Disease of the MC4R Pathway.’ The study aims to assess the long-term safety and tolerability of setmelanotide in patients with obesity related to defects in the leptin-melanocortin pathway, highlighting its potential significance in treating rare genetic obesity disorders.
Intervention/Treatment: The study tests setmelanotide, a drug administered via daily subcutaneous injections, designed to address obesity by targeting the MC4R pathway, a crucial component in energy balance and appetite regulation.
Study Design: This Phase 3 interventional study follows a single-group model without masking, focusing on treatment as its primary purpose. The open-label design allows all participants to receive the active drug, setmelanotide, to evaluate its long-term effects.
Study Timeline: The study began on September 10, 2024, with its primary completion and estimated overall completion dates yet to be announced. The latest update was submitted on September 2, 2025, indicating ongoing progress and data collection.
Market Implications: This study update could positively influence Rhythm Pharmaceuticals’ stock performance by reinforcing investor confidence in setmelanotide’s potential. As the company advances in addressing rare obesity disorders, it may gain a competitive edge in the biopharmaceutical industry, particularly if results demonstrate significant efficacy and safety.
The study is currently ongoing, with further details available on the ClinicalTrials portal.