Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants Wit… (NCT02311673) | Clinical Trial Compass
CompletedPhase 2
Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome
United States40 participantsStarted 2015-03-19
Plain-language summary
The purpose of this study was to evaluate the effects of a once daily subcutaneous injectable formulation of setmelanotide in obese participants with Prader-Willi syndrome on tolerability, weight loss, and hyperphagia-related behavior. The study drug (setmelanotide and placebo) was administered in a blinded fashion.
Who can participate
Age range16 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. PWS due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting defect, confirmed by fluorescent in situ hybridization, chromosomal microarray, and/or methylation studies. Obese male or female participants weighing at least 50 kilograms (kg) with body mass index (BMI) ≥ 27 kilogram per square meter (kg/m²)
✓. Age 16-65 years
✓. If a participant has diagnosis of type 2 diabetes, following criteria must be met:
✓. hemoglobin A1C (HbA1c) \< 7.5% not being managed with insulin. Participants taking glucagon-like peptide-1 (GLP-1) analogues (exenatide or liraglutide) must have been on stable dose for greater than 3 months.
✓. Fasting plasma glucose \< 140 milligrams per deciliter (mg/dL)
✓. No history of ketoacidosis or hyperosmolar coma
✓. Vital signs must be within the following ranges and stable.
✓. Systolic blood pressure, 90-150 millimeter of mercury (mm Hg)
Exclusion criteria
✕. Recent use (within 3 month) of weight loss agents including herbal medication.
✕. Diagnosis of schizophrenia, bipolar disorder, personality disorder or other Diagnostic and Statistical Manual of Mental Disorders, Third Edition (DSM-III) disorders which the investigator believes will interfere significantly with study compliance.
✕. A Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15.
What they're measuring
1
Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) - Period 2
Timeframe: Days 15 to 41
2
Number of Participants Who Experienced a TEAE - Period 3
Timeframe: Days 42 to 55
3
Number of Participants Who Experienced a TEAE - Period 4
Timeframe: Days 56 to 69
4
Mean Body Weight - Period 2
Timeframe: Baseline (Day 15)
5
Percent Change From Baseline in Body Weight - Period 2
Timeframe: Baseline (Day 15) and Day 42
6
Overall Score of Prader-Willi Syndrome (PWS) Hyperphagia Questionnaire - Period 2
Timeframe: Baseline (Day 15)
7
Percent Change From Baseline in Overall Score of Prader-Willi Syndrome (PWS) Hyperphagia Questionnaire - Period 2
✕. Diagnosis of type 1 diabetes mellitus or other active endocrine disorders (e.g., Cushing syndrome, or thyroid dysfunction except if on adequate thyroid or glucocorticoid replacement supplement).