Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome (NCT05322096) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome
United States, Czechia, France39 participantsStarted 2022-09-22
Plain-language 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).
Who can participate
Age range
17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Age Limits:
* In United States (USA), minimum age will be 17 years old.
* In European Union (EU) countries, minimum age will be 18 years old.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 othe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.