ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of Obesity

July 17, 2012 updated by: Zafgen, Inc.

ZGN-440 (Beloranib for Subcutaneous Injection), A Novel Methionine Aminopeptidase 2 Inhibitor for Treatment of Obesity: A Randomized Double-Blind Placebo Controlled Dose Escalation Phase 1b Trial to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Initial Weight Loss

The purpose of this study is to assess the Pharmacokinetics/Pharmacodynamics (PK/PD), safety, and effectiveness of multiple subcutaneous doses of Beloranib (ZGN-440).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This protocol is designed to test the safety and efficacy of a drug called Beloranib (ZGN-440). It is to be tested for its ability to reduce weight in obese female subjects who are of non-childbearing potential. The study will provide information on how much ZGN-440 gets into the blood, how long it stays in the body, and how it affects other biological markers.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

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
    • Queensland
      • Brisbane, Queensland, Australia
        • Q-Pharm Clinics, Royal Brisbane and Women's Hospital

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 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Obese but otherwise healthy females
  • Non-childbearing potential (surgically sterile, post-menopausal, or receiving implanted or injectable contraceptive for at least 3 months)
  • BMI ≥ 30 and ≤ 45 kg/m2
  • Stable body weight during the past 2 months

Exclusion Criteria:

  • Use of weight loss agents in the past month
  • History of eating disorder
  • History of type 1 or type 2 diabetes mellitus
  • Current smokers

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
Drug: ZGN-440 sterile diluent
Subjects will receive placebo twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
Experimental: ZGN-440
Drug: ZGN-440
Subjects will receive ZGN-440 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
Other Names:
  • Beloranib for subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate safe doses of ZGN-440 for reduction of body weight in obese female volunteers.
Time Frame: Approximately 4 weeks
Measures of the safety and tolerability of ZGN-440 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests.
Approximately 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence, severity and dose-relationship of adverse events as well as changes in physical examinations, ECGs, vital signs and/or laboratory evaluations as a measure of safety and tolerability.
Time Frame: Approximately 4 weeks
Approximately 4 weeks
Peak plasma concentration of ZGN-440 to assess relationship to weight loss.
Time Frame: Approximately 4 weeks
Approximately 4 weeks
Elimination half-life of ZGN-440 to assess relationship to weight loss.
Time Frame: Approximately 4 weeks
Approximately 4 weeks

Collaborators and Investigators

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

Sponsor

Zafgen, Inc.

Investigators

  • Principal Investigator: J K Marjason, MD, Q-Pharm Clinics, Royal Brisbane and Women's Hospital

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

December 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

January 5, 2012

First Submitted That Met QC Criteria

January 9, 2012

First Posted (Estimate)

January 10, 2012

Study Record Updates

Last Update Posted (Estimate)

July 18, 2012

Last Update Submitted That Met QC Criteria

July 17, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZAF-101

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.

Clinical Trials on Obesity

Clinical Trials on ZGN-440 sterile diluent

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe