Rhythm Pharmaceuticals announced expanded Phase 3 TRANSCEND trial data showing an 18.8% placebo-adjusted BMI reduction at 52 weeks for setmelanotide in acquired hypothalamic obesity, with FDA PDUFA goal date set for March 20, 2026.
Aardvark Therapeutics has voluntarily paused its Phase 3 HERO trial testing ARD-101 for hyperphagia in Prader-Willi Syndrome patients after reversible cardiac observations were identified during safety monitoring, delaying expected topline data beyond Q3 2026.
Soleno Therapeutics provided updates on its VYKAT XR commercial launch for Prader-Willi syndrome, reporting reimbursement progress across nearly 48 Medicaid programs and over 600 prescribers, while European regulatory review continues for approximately 9,500 additional patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07197034 |
The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial |
SUSPENDED | PHASE3 |
| NCT07031037 |
Exploratory Study of Sensory Profile and Coping Strategies in Eating Disorders |
NOT_YET_RECRUITING | |
| NCT06900335 |
Functional Connectome in Prader-Willi Syndrome: Neuroimaging and AI to Assess Therapeutic Impact |
COMPLETED | |
| NCT06828861 |
ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial |
SUSPENDED | PHASE3 |
| NCT06772597 |
A Study of Setmelanotide in Patients With Prader-Willi Syndrome |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT06239064 |
Early Genetic Identification of Obesity |
ACTIVE_NOT_RECRUITING | |
| NCT05939453 |
Impact of Bright Light Therapy on Prader-Willi Syndrome |
RECRUITING | NA |
| NCT05200182 |
fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating |
RECRUITING | NA |
| NCT05044000 |
Effect of Deep Propioceptive Stimulation in Prader-Willi Syndrome |
COMPLETED | NA |
| NCT04150991 |
Fiber Intervention on Gut Microbiota in Children With Prader-Willi Syndrome |
COMPLETED | NA |
