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

July 14, 2016 updated by: Zafgen, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610-0296
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: ZGN-440 sterile diluent
Subjects will receive placebo twice weekly subcutaneous injections for up to 6 weeks.
Drug: ZGN-440 sterile diluent
ZGN-440 sterile diluent/placebo
Other Names:
  • Placebo
Experimental: 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.
Drug: 1.2 mg ZGN-440 for injectable suspension
1.2 mg beloranib
Other Names:
  • ZGN-440 for injectable suspension
  • ZGN-440
  • ZGN-433
  • Beloranib
Experimental: 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.
Drug: 1.8 mg ZGN-440 for injectable suspension
1.8 mg beloranib
Other Names:
  • ZGN-440 for injectable suspension
  • ZGN-440
  • ZGN-433
  • Beloranib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in body weight from baseline to the end of the randomized dosing period.
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in body weight (kg) from baseline to the end of the randomized dosing period
Time Frame: 4 weeks
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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zafgen, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (Estimate)

March 27, 2013

Study Record Updates

Last Update Posted (Estimate)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 14, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZAF-211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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