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

Brief description of study

The hypothalamus is a small but complex part of the brain. It is an important regulator of body temperature, appetite, and hormone secretion. The hypothalamus secretes a hormone called melanin-concentrating hormone (MCH). This hormone, when it attaches to specific receptors (chemical structures that receive signals) in the brain, it increases the desire to eat. An intense desire to eat is called hyperphagia. Hyperphagia commonly occurs in people with Prader-Willi Syndrome (PWS), and there are currently no approved drugs to help control this. Hyperphagia can lead to overeating and obesity. The sponsor of the study, Gedeon Richter Plc, has designed RGH-706 to block MCH from binding to specific receptors to help control the desire to eat. The purpose of this study is to learn more about the impact of this experimental drug to improve hyperphagia and to gain understanding about various safety measures and tolerability of RGH-706 in patients with PWS who have hyperphagia. This will be the first time RGH-706 has been studied in patients with PWS.

Clinical Study Identifier: s22-00255
ClinicalTrials.gov Identifier: NCT05322096
Principal Investigator: Jorge Mejia-Corletto.

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