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MCHR1 Antagonist

RGH-706 for Prader-Willi Syndrome

Phase 2

Waitlist Available

Research Sponsored by Gedeon Richter Plc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Negative pregnancy test for females of childbearing potential and nonlactating at screening

Male or female patients aged ≥17 years in USA at screening or aged ≥18 years in EU at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part a: screening, days 1, 14, 28, 42, 56, 98 and 133; part b: screening, days 1, 14, 28, 42, 70, 105 and 119

Awards & highlights

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.

Who is the study for?

This trial is for individuals with Prader-Willi Syndrome (PWS) who are adults, weigh between 88 and 450 lbs, and have a stable body weight. They must not be pregnant or breastfeeding, should not have had bariatric surgery, severe psychiatric disorders, uncontrolled thyroid issues or sleep apnea, recent use of weight-lowering drugs, heart problems like QT prolongation, uncontrollable diabetes requiring insulin, cancer in the last 5 years or any other major health issues.Check my eligibility

What is being tested?

The study tests RGH-706's effectiveness for weight management in PWS patients against a placebo. It's a Phase 2 trial where participants will randomly receive either the drug candidate RGH-706 or an inactive substance to compare outcomes regarding safety and how well they tolerate the treatment.See study design

What are the potential side effects?

While specific side effects of RGH-706 aren't listed here as it's still under investigation; generally such medications can cause digestive discomforts, changes in appetite or mood swings. The study aims to identify these potential adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant or breastfeeding.

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I am at least 17 years old in the USA or 18 in the EU.

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My weight is between 88 lbs and 450 lbs.

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My condition is genetically confirmed Prader-Willi Syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part a: screening, days 1, 14, 28, 42, 56, 98 and 133; part b: screening, days 1, 14, 28, 42, 70, 105 and 119

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part a: screening, days 1, 14, 28, 42, 56, 98 and 133; part b: screening, days 1, 14, 28, 42, 70, 105 and 119

This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: screening, days 1, 14, 28, 42, 56, 98 and 133; part b: screening, days 1, 14, 28, 42, 70, 105 and 119 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A: Change from baseline in the 9-item Hyperphagia Questionnaire for Clinical Trials (HQ-CT)

Part B: Change from baseline in the 9-item Hyperphagia Questionnaire for Clinical Trials (HQ-CT)

Secondary outcome measures

Part A and Part B: Absolute change from baseline in body weight

Part A and Part B: Caregiver Global Impression-Change (CaGI-C)

Part A and Part B: Change from baseline in Caregiver Global Impression-Severity (CaGI-S)

+20 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RGH-706Experimental Treatment1 Intervention

Part A: Dose A once daily for 6 weeks Part B: Dose B, Dose C or Dose D once daily (depending on the randomized arm) for 13 weeks

Group II: PlaceboPlacebo Group1 Intervention

Part A: Placebo once daily for 6 weeks Part B: Placebo once daily for 13 weeks

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gedeon Richter Plc.Lead Sponsor

11 Previous Clinical Trials

3,617 Total Patients Enrolled

Media Library

RGH-706 (MCHR1 Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05322096 — Phase 2

Prader-Willi Syndrome Research Study Groups: Placebo, RGH-706

Prader-Willi Syndrome Clinical Trial 2023: RGH-706 Highlights & Side Effects. Trial Name: NCT05322096 — Phase 2

RGH-706 (MCHR1 Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05322096 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05322096.