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

Zafgen, Inc.17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obesity Over-weight Prader-Willi Syndrome

Interventions

ZGN-440 sterile diluentDRUG

ZGN-440 sterile diluent/placebo

1.2 mg ZGN-440 for injectable suspensionDRUG

1.2 mg beloranib

1.8 mg ZGN-440 for injectable suspensionDRUG

1.8 mg beloranib

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Florida

Gainesville, Florida, United States

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

Time frame: 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

Time frame: 4 weeks

Data from ClinicalTrials.gov

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