Randomized, Double-Blind, Placebo Controlled, Parallel Dose Ranging Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Over-weight and Obese Subjects With Prader-Willi Syndrome to Evaluate Weight Reduction, Food-related Behavior, Safety, and Pharmacokinetics Over 4 Weeks Followed by Optional 4-Week Open-Label Extension

Zafgen, Inc.1 site in 1 country17 target enrollmentJune 2013

ConditionsObesity Over-weight Prader-Willi Syndrome

InterventionsZGN-440 sterile diluent 1.2 mg ZGN-440 for injectable suspension 1.8 mg ZGN-440 for injectable suspension

DrugsZGN-440 sterile diluent 1.2 mg ZGN-440 for injectable suspension 1.8 mg ZGN-440 for injectable suspension

Overview

Phase: Phase 2
Intervention: ZGN-440 sterile diluent
Conditions: Obesity
Sponsor: Zafgen, Inc.
Enrollment: 17
Locations: 1
Primary Endpoint: Percent change in body weight from baseline to the end of the randomized dosing period.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

November 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zafgen, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

ZGN-440 sterile diluent

Subjects will receive placebo twice weekly subcutaneous injections for up to 6 weeks.

Intervention: ZGN-440 sterile diluent

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.

Intervention: 1.2 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.

Intervention: 1.8 mg ZGN-440 for injectable suspension

Outcomes

Primary Outcomes

Percent change in body weight from baseline to the end of the randomized dosing period.

Time Frame: 4 weeks

Secondary Outcomes

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)