An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome

Phase 2

Completed

• Conditions: Obesity; Over-weight; Prader-Willi Syndrome
• Interventions: Drug: 1.8 mg ZGN-440 for injectable suspension; Drug: 1.2 mg ZGN-440 for injectable suspension; Drug: ZGN-440 sterile diluent

• Registration Number: NCT01818921
• Lead Sponsor: Zafgen, Inc.

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for certain doses of beloranib in obese subjects with Prader-Willi Syndrome.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-27
• Study Start: 2013-06
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2016-07
• Disposition First Submitted: 2016-07-14
• Disposition First Submitted QC: 2016-07-14
• Last Update Submitted: 2016-07-14
• Disposition First Posted: 2016-07-18
• Last Update Posted: 2016-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Confirmed diagnosis of Prader-Willi Syndrome due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting defect
• BMI ≥25 kg/m2
• Type 2 diabetes mellitus is allowed
• Subject must agree to stay at the group home or under supervision of the group home or site staff (i.e. no home visits) for the duration of the study
• Stable body weight during the past 3 months, except for during home visits

Exclusion Criteria

• Use of weight loss agents in the past 3 months
• Type 1 diabetes mellitus
• Current or anticipated chronic use of narcotics or opiates

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.8 mg ZGN-440 for injectable suspension	1.8 mg ZGN-440 for injectable suspension	Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.
1.2 mg ZGN-440 for injectable suspension	1.2 mg ZGN-440 for injectable suspension	Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.
ZGN-440 sterile diluent	ZGN-440 sterile diluent	Subjects will receive placebo twice weekly subcutaneous injections for up to 6 weeks.

Primary Outcome Measures

Name	Time	Method
Percent change in body weight from baseline to the end of the randomized dosing period.	4 weeks

Secondary Outcome Measures

Name	Time	Method
Change in body weight (kg) from baseline to the end of the randomized dosing period	4 weeks
Change in hyperphagia behavior, drive, and severity score (total score) from baseline to the end of the randomized dosing period using the PWS Hyperphagia Questionnaire	4 weeks

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States