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RGH-706 for Prader-Willi Syndrome
Study Summary
This trial will help to show if the drug candidate RGH-706 is effective in managing weight for people with Prader-Willi Syndrome, as well as if it is safe and well tolerated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am not pregnant or breastfeeding.You have a known heart condition that affects the timing of your heartbeats.I haven't taken any weight-loss drugs in the last 6 months.I do not have severe psychiatric disorders like schizophrenia, bipolar, or major depression in the last 6 months.You have significant abnormal results in your lab tests that could affect your health.Your blood pressure is very high, or your heart rate is very fast, when checked at the beginning of the study.Your body weight has not changed significantly.My diabetes cannot be controlled or requires insulin.The doctor thinks you might be at risk of hurting yourself.I am at least 17 years old in the USA or 18 in the EU.My weight is between 88 lbs and 450 lbs.My condition is genetically confirmed Prader-Willi Syndrome.You scored 14 or higher on the HQ-CT test during screening.I have had cancer within the last 5 years.I have sleep apnea that is not well-managed.I have liver disease.I have had weight loss surgery in the past.My thyroid condition is not well-managed.
- Group 1: Placebo
- Group 2: RGH-706
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
To date, how many people have enrolled in this clinical trial?
"As specified in the trial's inclusion criteria, a total of 176 patients are required to complete the study. The sponsor, Gedeon Richter Plc., is conducting the trial at multiple locations including Morgan Stanley Children's Hospital of NewYork-Presbyterian and NYU Langone Hospital-Long Island."
When might the FDA approve RGH-706?
"Given that this is a Phase 2 trial and there is some data supporting safety but none yet for efficacy, our team has given RGH-706 a score of 2."
How many places are conducting this research?
"Currently, this study is enrolling patients at 14 sites. The locations are based in New york, Mineola and San Diego to name a few other 14 locations. To minimize travel demands, it is important to select the clinic closest to you if you decide to enroll in this study."
Are there any current openings for patients who wish to participate in this trial?
"The trial mentioned is still recruiting patients, according to the information found on clinicaltrials.gov. This particular study was first advertised on September 22nd, 2022 and has since been updated on October 28th of the same year."
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