Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome
NCT ID: NCT05322096
Last Updated: 2024-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
39 participants
INTERVENTIONAL
2022-09-22
2024-04-10
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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RGH-706
Dose A once daily for 6 weeks
RGH-706
Capsules
Oral administration
Placebo
Placebo once daily for 6 weeks
Placebo
Capsules
Oral administration
Interventions
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RGH-706
Capsules
Oral administration
Placebo
Capsules
Oral administration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
17 Years
ALL
No
Sponsors
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Gedeon Richter Plc.
INDUSTRY
Responsible Party
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Locations
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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"
Napoli, , 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
Countries
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Other Identifiers
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2021-004262-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RGH-706-003
Identifier Type: -
Identifier Source: org_study_id
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