Obesity, Prader-Willi Syndrome
Conditions
Keywords
Prader-Willi Syndrome, Obesity, Hyperphagia
Brief summary
The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adolescent and adult subjects with Prader-Willi Syndrome.
Detailed description
Phase 3, Randomized, Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Subcutaneous Beloranib in Suspension) in Obese Subjects with Prader-Willi Syndrome to Evaluate Total Body Weight, Food-related Behavior, and Safety Over 6 Months
Interventions
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 28 weeks.
Subjects will receive placebo twice weekly subcutaneous injections for up to 28 weeks.
Sponsors
Zafgen, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed genetic diagnosis of Prader-Willi Syndrome * Age 12-65 * Obesity * Age 12-17: BMI ≥ 95th percentile for age and gender * Age 18-65: BMI ≥27 to ≤60 kg/m2
Exclusion criteria
* Subjects living in a group home ≥ 50% of the time * Recent use (within 3 months) of weight loss agents including herbal medication * Poorly controlled severe psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hyperphagia-related behavior as measured by total score of a Hyperphagia Questionnaire | Baseline to Week 29 |
| Change in total body weight | Baseline to Week 29 |
Secondary
| Measure | Time frame |
|---|---|
| Change in total body mass as measured by DXA | Baseline to Week 29 |
| Change in LDL cholesterol | Baseline to Week 29 |
| Change in triglyceride | Baseline to Week 29 |
| Change in total body fat mass as measured by DXA | Baseline to Week 29 |
| Change in HDL cholesterol | Baseline to Week 29 |
Countries
United States
Outcome results
None listed