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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
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.
University of California, Davis
Sacramento, California, United States
UCSD: Rady Children's Hospital
San Diego, California, United States
Change in total body weight
Time frame: Baseline to Week 29
Change in hyperphagia-related behavior as measured by total score of a Hyperphagia Questionnaire
Time frame: Baseline to Week 29
Change in LDL cholesterol
Time frame: Baseline to Week 29
Change in HDL cholesterol
Time frame: Baseline to Week 29
Change in total body mass as measured by DXA
Time frame: Baseline to Week 29
Change in total body fat mass as measured by DXA
Time frame: Baseline to Week 29
Change in triglyceride
Time frame: Baseline to Week 29
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