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Rhythm Pharmaceuticals Announces Oral MC4R Agonist Bivamelagon Achieved Statistically Significant, Clinically Meaningful BMI Reductions in Placebo-controlled Phase 2 Trial in Acquired Hypothalamic Obesity
-- Bivamelagon achieved BMI reductions in patients with acquired hypothalamic obesity of -9.3% and -7.7% in 600mg and 400mg cohorts, respectively, at 14 weeks
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- Bivamelagon achieved BMI reductions in patients with acquired hypothalamic obesity of -9.3% and -7.7% in 600mg and 400mg cohorts, respectively, at 14 weeks -- -- Post-hoc analysis showed BMI reductions in bivamelagon trial were consistent with BMI reductions achieved by setmelanotide in past trials in similar patient populations -- -- Patients in both 600mg and 400mg cohorts achieved mean reduction of -2.8 points in most hunger scores -- -- Limited instances of localized hyperpigmentation observed -- -- Rhythm to request End-of-Phase 2 meeting with U.S. FDA in order to pursue registrational path for bivamelagon in acquired hypothalamic obesity -- -- Company to host conference call today at 8 a.m. ET -- BOSTON, July 09, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced positive topline results from its Phase 2 trial evaluating bivamelagon (formerly LB54640), an investigational oral melanocortin-4 receptor (MC4R) agonist, in patients with acquired hypothalamic obesity. Bivamelagon achieved statistically significant and clinically meaningful reductions in body mass index (BMI) at 14 weeks of treatment, consistent with BMI reductions achieved with setmelanotide therapy in similar patient populations in past trials. Rhythm in-licensed bivamelagon from LG Chem, Ltd in January 2024. In the 14-week, double-blind, four-arm, placebo-controlled portion of the trial, bivamelagon achieved: -9.3% BMI reduction from baseline in the 600mg cohort (n=8) (p-value=0.0004);-7.7% BMI reduction from baseline in the 400mg cohort (n=7) (p-value=0.0002);-2.7% BMI reduction from baseline in the 200mg cohort (n=6) (p-value=0.0180); andBMI for patients in the placebo cohort (n=7) increased by 2.2% over 14 weeks. “We are excited by these results, which suggest bivamelagon has the potential to treat patients with acquired hypothalamic obesity, and has established an appropriate dose range for future clinical evaluation. Unlike in studies evaluating general obesity, once again we observed no placebo effect in this study,” said David Meeker, M.D., Chair, Chief Executive Officer and President of Rhythm Pharmaceuticals. “We look forward to engaging with U.S. and European regulatory autho...