An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury

July 14, 2016 updated by: Zafgen, Inc.

Randomized, Double-Blind, Placebo Controlled, Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Obese Subjects With Hypothalamic Injury to Evaluate Weight Reduction and Safety Over 4 Weeks Followed by an Optional 4-Week Open-Label Extension

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of beloranib in obese subjects with hypothalamic injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

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

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2006
        • The Boden Institute
    • Victoria
      • Heidelberg Heights, Victoria, Australia, 3081
        • Austin Health, Metabolic Disorders Centre
  • United States
    • Minnesota
      • St. Paul, Minnesota, United States, 55102
        • Children's Hospitals and Clinics of Minnesota
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obesity as a consequence of acquired anatomical hypothalamic damage as evidenced by BMI ≥30 and ≤60 kg/m2
  • Greater than 6 months post-treatment, including chemotherapy, surgery or radiation with resulting injury to the hypothalamus and/or the pituitary
  • Stable body weight for at least 3 months
  • Type 2 diabetes mellitus is allowed

Exclusion Criteria:

  • Males taking gonadotropin replacement therapy (LH/FSH)
  • Subjects who are planning any fertility treatment within 6 months of study participation
  • Use of weight loss agents, including herbal medications, in the past 3 months
  • Current or anticipated chronic use of narcotics or opiates
  • History of severe psychiatric disorders
  • Type 1 diabetes mellitus
  • Metabolic disorders or genetic disorders linked to obesity
  • History of any bariatric surgery
  • Participation in any clinical study with an investigational drug or device within the 3 months prior to enrollment in this study
  • Blood loss or donation >500 mL within the past 3 months
  • Females who are pregnant, nursing, intend to become pregnant during the study or any males who plan to father/conceive a child within 6 months after completion of study participation

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: ZGN-440 sterile diluent
Subjects will receive placebo twice weekly subcutaneous injections for 4 weeks.
Drug: ZGN-440 sterile diluent
ZGN-440 sterile diluent/placebo
Other Names:
  • Placebo
Experimental: ZGN-440 for injectable suspension
Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.
Drug: ZGN-440 for injectable suspension
Other Names:
  • ZGN-440
  • Beloranib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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 lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period
Time Frame: 4 weeks
4 weeks
Change in hs-CRP from baseline to the end of the randomized dosing period.
Time Frame: 4 weeks
4 weeks
Change in hunger from baseline to the end of the randomized dosing period.
Time Frame: 4 weeks
4 weeks
Change in quality of life from baseline to the end of the randomized dosing period.
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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 14, 2014

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-221

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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