Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02179151
• Date of registration: 25/06/2014
• Prospective Registration: Yes
• Primary sponsor: Zafgen, Inc.
• Public title: Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome bestPWS
• Scientific title: 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
• Date of first enrolment: September 2014
• Target sample size: 108
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02179151
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Dennis Kim, MD
• Affiliation: Zafgen, Inc.

Key inclusion & exclusion criteria

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



Age minimum: 12 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obesity

Prader-Willi Syndrome

Intervention(s)

Drug: ZGN-440 Placebo for Injectable Suspension

Drug: ZGN-440 for Injectable Suspension

Primary Outcome(s)

Change in hyperphagia-related behavior as measured by total score of a Hyperphagia Questionnaire [Time Frame: Baseline to Week 29]

Change in total body weight [Time Frame: Baseline to Week 29]

Secondary Outcome(s)

Change in total body mass as measured by DXA [Time Frame: Baseline to Week 29]

Change in LDL cholesterol [Time Frame: Baseline to Week 29]

Change in triglyceride [Time Frame: Baseline to Week 29]

Change in HDL cholesterol [Time Frame: Baseline to Week 29]

Change in total body fat mass as measured by DXA [Time Frame: Baseline to Week 29]

Secondary ID(s)

ZAF-311

Source(s) of Monetary Support

Please refer to primary and secondary sponsors