Status:
COMPLETED
Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome
Lead Sponsor:
Gedeon Richter Plc.
Conditions:
Prader-Willi Syndrome
Eligibility:
All Genders
17+ years
Phase:
PHASE2
Brief 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-con...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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
Key Trial Info
Start Date :
September 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2024
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT05322096
Start Date
September 22 2022
End Date
April 10 2024
Last Update
June 3 2024
Active Locations (23)
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1
Rady Children's Hospital-San Diego
San Diego, California, United States, 92123
2
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
3
Maimonides Medical Center
Brooklyn, New York, United States, 11219
4
NYU Langone Hospital-Long Island
Mineola, New York, United States, 11501