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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004262-35 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RGH-706 | Experimental | Dose A once daily for 6 weeks |
|
| Placebo | Placebo Comparator | Placebo once daily for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RGH-706 | Drug | Capsules Oral administration |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| There are no Primary Outcome Measures | There are no Primary Outcome Measures |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the 9-item Hyperphagia Questionnaire for Clinical Trials (HQ-CT) | The HQ-CT is a questionnaire designed to measure symptoms of food-related preoccupations, problems, and behaviors completed by the caregiver. The scale provides a composite value from 9 questions, each rated on a scale of 0 to 4 units (possible total score range: 0 to 36). Higher scores represent increased hyperphagia. |
Age Limits:
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital-San Diego | San Diego | California | 92123 | United States | ||
| Ann & Robert H. Lurie Children's Hospital of Chicago |
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| Drug |
Capsules Oral administration |
|
| Baseline to Day 42 |
| Change from baseline in the 9-item Hyperphagia Questionnaire for Clinical Trials (HQ-CT) | The HQ-CT is a questionnaire designed to measure symptoms of food-related preoccupations, problems, and behaviors completed by the caregiver. It consists of 9 items, with a 2-week recall period. The scale provides a composite value from 9 questions, each rated on a scale of 0 to 4 units (possible total score range: 0 to 36). Higher scores represent increased hyperphagia. | Baseline to Days 28, 56, 98 and 133 |
| Change from baseline in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) domain scores (drive and severity, self-directed behavior) | The HQ-CT is a questionnaire designed to measure symptoms of food-related preoccupations, problems, and behaviors completed by the caregiver. The scale provides a composite value from 9 questions, each rated on a scale of 0 to 4 units (possible total score range: 0 to 36). Higher scores represent increased hyperphagia. | Baseline to Days 28, 42, 56, 98 and 133 |
| Absolute change from baseline in body weight | Screening, Days 1, 14, 28, 42, 56, 98 and 133 |
| Percentage change from baseline in body weight | Screening, Days 1, 14, 28, 42, 56, 98 and 133 |
| Change from baseline in waist circumference | Screening, Days 1, 14, 28, 42, 56, 98 and 133 |
| Change from baseline in body mass index (BMI) | Screening, Days 1, 14, 28, 42, 56, 98 and 133 |
| Change from baseline in metabolic biomarkers measured from serum | Baseline to Day 42 |
| Change from baseline in Clinical Global Impression-Severity (CGI-S) | The CGI-S rates overall symptom severity on a 4-point scale ranging from 1 (normal) to 7 (severely symptomatic), as assessed by the investigator. | Baseline to Days 28, 42 and 56 |
| Clinical Global Impression-Improvement (CGI-I) | The CGI-I is a single statement designed to assess the investigator's overall perception of change in the patient's condition across the course of the clinical trial. The CGI-I uses a 7-point response scale ranging from 1 (very much improved) to 7 (very much worse). | Days 28 and 42 |
| Change from baseline in Caregiver Global Impression-Severity (CaGI-S) | The CaGI-S rates severity of the patient's food-related behavior assessed by the caregiver following a 4-point scale ranging from 0 (none) to 3 (severe). | Baseline to Days 2 and 42 |
| Caregiver Global Impression-Change (CaGI-C) | The CaGI-C is a single item designed to assess the primary caregiver's overall perception of change in the patient's hyperphagia symptoms. Responses are rated using a 7-point scale ranging from 1 (much better) to 7 (much worse). | Days 28, 42, 56, 98 and 133 |
| Change from baseline in Zarit Burden Interview-22 (ZBI-22) | The ZBI-22 is a self-reported questionnaire in which primary caregivers rate the level of burden currently experienced while taking care of the patient rated on a 5-point scale ranging from 0 (never) to 4 (nearly always). | Baseline to Day 42 |
| Safety - Incidence of treatment-emergent adverse events (TEAEs) | Screening thru study end; Up to 24 weeks |
| Safety - Incidence of clinically significant findings in laboratory values | Clinical laboratory evaluations (hematology, clinical chemistry, coagulation and lipids, thyroid function test, and urinalysis) | Screening thru study end; Up to 24 weeks |
| Safety - Incidence of clinically significant findings in vital signs | Vital signs measurements (body temperature, pulse rate, respiration rate, blood pressure [BP]) | Screening thru study end; Up to 24 weeks |
| Safety - Incidence of clinically significant findings in 12-lead electrocardiograms (ECGs) | Screening thru study end; Up to 24 weeks |
| Safety - Incidence of clinically significant findings in Columbia-Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a clinician-rated instrument that captures the occurrence, severity, and frequency of suicidal ideation and/or behavior during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if suicidal ideation and/or behavior occurred. | Screening thru study end; Up to 24 weeks |
| Safety - Incidence of clinically significant findings in laboratory values physical examinations | Screening thru study end; Up to 24 weeks |
| PK Cohort - Individual plasma concentrations of RGH-706 and its metabolite desisopropyl RGH-706 maximum observed plasma concentration (Cmax) | Days 14, 42, 43, 44 and 46 |
| PK Cohort - Individual plasma concentrations of RGH-706 and its metabolite desisopropyl RGH-706 time of the maximum observed plasma concentration (Tmax) | Days 14, 42, 43, 44 and 46 |
| PK Cohort - Individual plasma concentrations of RGH-706 and its metabolite desisopropyl RGH-706 area under the plasma concentration-time curve to the end of the dosing period (AUC0-24) | Days 14, 42, 43, 44 and 46 |
| PK Cohort - Individual plasma concentrations of RGH-706 and its metabolite desisopropyl RGH-706 minimum observed plasma concentration (Cmin) | Days 14, 42, 43, 44 and 46 |
| PK Cohort - Individual plasma concentrations of RGH-706 and its metabolite desisopropyl RGH-706 accumulation ratio (Rac) | Days 14, 42, 43, 44 and 46 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
| NYU Langone Hospital-Long Island | Mineola | New York | 11501 | United States |
| Morgan Stanley Children's Hospital of NewYork-Presbyterian | New York | New York | 10032 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| General University Hospital | Prague | 12808 | Czechia |
| Centre Hospitalier Universitaire d'Angers | Angers | 49933 | France |
| Centre Hospitalier Lyon-Sud | Pierre-Bénite | 69495 | France |
| Hôpital Larrey | Toulouse | 31059 | France |
| Azienda Ospedaliero-Universitaria Careggi | Florence | 50139 | Italy |
| Istituto Giannina Gaslini | Genova | 16147 | Italy |
| Azienda Ospedaliera Universitaria "Federico II" | Naples | 80131 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli | Roma | 168 | Italy |
| IRCCS Ospedale Pediatrico Bambino Gesù | Roma | 50 | Italy |
| Oasi Maria SS | Troina | 94018 | Italy |
| Hospital General Universitario Dr. Balmis | Alicante | 03010 | Spain |
| Hospital General Universitario Gregorio Maranon-Instituto Provincial de Psiquiatria y Salud Mental | Madrid | 28009 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Regional Universitario de Málaga - Hospital General | Málaga | 29010 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Parc Taulí Sabadell Hospital Universitari | Sabadell | 08208 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| ID | Term |
|---|---|
| D011218 | Prader-Willi Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D000096803 | Imprinting Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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