Rhythm Pharmaceuticals to Announce Topline Results from Phase 3 TRANSCEND Trial of Setmelanotide in Acquired Hypothalamic Obesity

07 April 2025 | Monday | News

The company will disclose pivotal clinical data on setmelanotide’s efficacy and safety in patients with acquired hypothalamic obesity during a live conference call and webcast on April 7, 2025.
Picture Courtesy | Public Domain

Picture Courtesy | Public Domain

Rhythm Pharmaceuticals, Inc., a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, announced the Company will hold a conference call and webcast on Monday, April 7, 2025 at 8:00 a.m. ET to disclose topline results from the Pivotal Phase 3 TRANSCEND trial evaluating setmelanotide, a melanocortin-4 receptor (MC4R) agonist, in patients with acquired hypothalamic obesity.


Rhythm Pharmaceuticals will host a live conference call and webcast at 8:00 a.m. ET on Monday, April 7, to discuss these clinical data. Participants may register for the conference call here. A webcast of the call will also be available under "Events and Presentations" in the Investor Relations section of the Rhythm Pharmaceuticals website at https://ir.rhythmtx.com/. The archived webcast will be available on Rhythm Pharmaceuticals’ website approximately two hours after the conference call and will be available for at least 30 days following the call.


The global, randomized, double-blind, placebo-controlled Phase 3 TRANSCEND trial evaluated the efficacy and safety of setmelanotide in patients with acquired hypothalamic obesity. A total of 120 patients age 4 years and older were randomized 2:1 to either a daily subcutaneous injection of setmelanotide or placebo. The primary endpoint was mean percent change in body mass index (BMI) from baseline after 52 weeks of treatment. Secondary endpoints are assessing daily hunger, hyperphagia (extreme unsatisfied drive to consume food), weight, quality of life and safety and tolerability. A supplemental cohort of 12 Japanese patients remains ongoing with completion and topline data anticipated in the first quarter of 2026.

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