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# Rhythm Pharma ‘Positive’ Data on Obesity Drug
- URL: https://www.fdaweb.com/rhythm-pharma-positive-data-on-obesity-drug/
- Published: 2025-04-07T12:00:00.000Z
- Updated: 2026-09-14T14:57:11.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158960

Rhythm Pharmaceuticals is reporting “positive topline results” from the pivotal Phase 3 TRANSCEND trial evaluating setmelanotide, a melanocortin-4 receptor agonist, for treating acquired hypothalamic obesity. The company says the trial met its primary of a “statistically significant and highly clinically meaningful reduction in body mass index (BMI)” for setmelanotide in adult and pediatric patients versus placebo. The data showed that a mean BMI reduction of 16.5% from baseline for setmelanotide therapy compared with a 3.3% increase in BMI change for patients on placebo.

“Acquired hypothalamic obesity is a serious disease resulting from damage to the hypothalamus, often due to brain tumors or their treatment or certain other injuries resulting in accelerated weight gain, hyperphagia and reduction in energy expenditure,” the company says.

No new safety signals with setmelanotide were observed, Rhythm says, adding that the most common treatment-emergent adverse events were nausea, vomiting, diarrhea, injection site reaction, skin hyperpigmentation and headache. “No serious adverse events leading to study discontinuation were reported,” it says.