Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome
Completed · Phase 2 · Has a placebo group
Conditions studied: Prader-Willi Syndrome
In brief
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).
Key facts
- Study ID
- NCT05322096
- Run by
- Gedeon Richter Plc.
- People needed
- 39
- Starts
- 2022-09-22
- Expected to finish
- 2024-04-10
- Last updated by the study team
- 2024-06-03
Who can join
Age: 17 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female patients aged ≥17 years in USA at screening or aged ≥18 years in EU at screening
- Genetically confirmed diagnosis of PWS
- HQ-CT total score ≥14 at screening
- Body weight ≥40 kg/88 lbs and ≤200 kg/450 lbs
- Stable body weight
- Negative pregnancy test for females of childbearing potential and nonlactating at screening.
- Patients must be able to provide or have a parent or guardian who is able to provide written informed consent and/or assent (as applicable)
- Patients must have at least 1 consistent and reliable primary caregiver
You may not qualify if…
- Severe psychiatric disorders (eg, schizophrenia, bipolar disorder, or major depressive disorder), recent (within 6 months)
- Risk of suicide according to the investigator's judgment
- Uncontrollable diabetes mellitus or diabetes mellitus requiring insulin administration
- Poorly controlled hypothyroidism or hyperthyroidism
- Chronic or acute liver disease
- History of bariatric surgery procedure
- Uncontrolled obstructive sleep apnea.
- History of malignancy within 5 years of screening
- Systolic blood pressure (BP) ≥160 mmHg and/or diastolic BP ≥100 mmHg, pulse rate ≥100/min at screening.
- Use of weight-lowering pharmacotherapy within 6 months prior to screening.
- Known QT prolongation
- Clinically relevant laboratory abnormalities
- Any other condition that, in the investigator's opinion, might indicate that the patient is unsuitable for the study
Where it is running
- Rady Children's Hospital-San Diego — San Diego, California, United States
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- Maimonides Medical Center — Brooklyn, New York, United States
- NYU Langone Hospital-Long Island — Mineola, New York, United States
- Morgan Stanley Children's Hospital of NewYork-Presbyterian — New York, New York, United States
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- General University Hospital — Prague, Czechia
- Centre Hospitalier Universitaire d'Angers — Angers, France
- Centre Hospitalier Lyon-Sud — Pierre-Bénite, France
- Hôpital Larrey — Toulouse, France
- Azienda Ospedaliero-Universitaria Careggi — Florence, Italy
- Istituto Giannina Gaslini — Genova, Italy
- Azienda Ospedaliera Universitaria "Federico II" — Naples, Italy
- Fondazione Policlinico Universitario Agostino Gemelli — Roma, Italy
- IRCCS Ospedale Pediatrico Bambino Gesù — Roma, Italy
- Oasi Maria SS — Troina, Italy
- Hospital General Universitario Dr. Balmis — Alicante, Spain
- Hospital General Universitario Gregorio Maranon-Instituto Provincial de Psiquiatria y Salud Mental — Madrid, Spain
- Hospital Universitario 12 de Octubre — Madrid, Spain
- Hospital Regional Universitario de Málaga - Hospital General — Málaga, Spain
- Hospital Universitario Virgen de la Victoria — Málaga, Spain
- Parc Taulí Sabadell Hospital Universitari — Sabadell, Spain
- Hospital Universitario Virgen del Rocío — Seville, Spain
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.