NCT05322096

Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome

A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Gedeon Richter Plc. · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

RGH-706 is a novel, potent, and orally active MCHR1 antagonist drug candidate discovered and being developed by Gedeon Richter Plc. for weight management. This will be the first Phase 2, proof-of-concept study using RGH-706 and is the third study in the clinical development program for RGH-706. The aim of this study is to evaluate the efficacy, safety, and tolerability of RGH-706 in patients with Prader-Willi Syndrome (PWS).

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
DRUG	RGH-706	Capsules Oral administration
DRUG	Placebo	Capsules Oral administration

Timeline

• Start date: 2022-09-22
• Primary completion: 2024-04-10
• Completion: 2024-04-10
• First posted: 2022-04-11
• Last updated: 2024-06-03

Locations

23 sites across 5 countries: United States, Czechia, France, Italy, Spain

Regulatory

• FDA-regulated drug study