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

Zafgen

Status and phase: Terminated; Phase 3

Conditions: Prader-Willi Syndrome; Obesity

Treatments: Drug: ZGN-440 for Injectable Suspension; Drug: ZGN-440 Placebo for Injectable Suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT02179151

ZAF-311

Details and patient eligibility

About

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.

Full 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

Enrollment: 108 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

108 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Intervention: ZGN-440 Placebo for Injectable Suspension

Treatment:

Drug: ZGN-440 Placebo for Injectable Suspension

ZGN-440 Injectable Suspension (1.8 mg)

Experimental group

Description:

Intervention: ZGN-440 for Injectable Suspension

Treatment:

Drug: ZGN-440 for Injectable Suspension

ZGN-440 Injectable Suspension (2.4 mg)

Experimental group

Description:

Intervention: ZGN-440 for Injectable Suspension

Treatment:

Drug: ZGN-440 for Injectable Suspension