Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes

May 22, 2019 updated by: Zafgen, Inc.

Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of ZGN-1061 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus to Evaluate Glycemic Control, Safety, and Tolerability Over 12 Weeks

The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061 in participants with type 2 diabetes.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Participants will be enrolled in 1 of 2 groups. Approximately 120 participants will receive 0.05, 0.3, or 0.9 mg of ZGN-1061 or placebo (Group 1). An additional 40 participants will receive 0.9 or 1.8 mg of ZGN-1061 or placebo (Group 2).

Study Type

Interventional

Enrollment (Actual)

188

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

    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • Northside Health
      • Coffs Harbour, New South Wales, Australia, 2450
        • Coffs Harbour GP SuperClinic
      • Merewether, New South Wales, Australia, 2291
        • The Aim Centre
      • Sydney, New South Wales, Australia, 2010
        • Holdsworth House Medical Practice
      • Sydney, New South Wales, Australia, 2006
        • The Boden Institute
      • Sydney, New South Wales, Australia, 2289
        • Pendlebury Research
    • Queensland
      • Herston, Queensland, Australia, 4006
        • Q-Pharm
      • Southport, Queensland, Australia, 4222
        • Griffith University, Gold Coast Campus
    • South Australia
      • Daw Park, South Australia, Australia, 5041
        • Southern Adelaide Diabetes & Endocrine Services
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Eastern Clinical Research Unit (ECRU)
      • Geelong, Victoria, Australia, 3218
        • Barwon Health
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
      • Auckland, New Zealand, 2025
        • Middlemore Hospital
      • Auckland, New Zealand, 1021
        • Optimal Clinical Trials
      • Christchurch, New Zealand, 8011
        • Christchurch Diabetes Centre
      • Christchurch, New Zealand, 8024
        • Southern Clinical Trials
      • Christchurch, New Zealand, 8140
        • Lipid and Diabetes Research Group
      • Hamilton, New Zealand, 3206
        • Clinical Trials New Zealand Ltd
      • Hastings, New Zealand, 4130
        • P3 Research Hawkes Bay
      • Newtown, New Zealand, 6021
        • P3 Research Wellington
      • Rotorua, New Zealand, 3010
        • Lakeland Clinical Trials
      • Tauranga, New Zealand, 3110
        • P3 Research Tauranga
      • Wellington, New Zealand, 6021
        • Wellington 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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must meet the following criteria to participate in this study:

  • Be between the ages of 18 and 70 years, inclusive.
  • Overweight or obese with a body mass index of at least 27 kg/m².
  • Have type 2 diabetes with HbA1c between 7% and 11%.
  • For subjects taking approved antidiabetes medications, the doses must be stable as determined by the study doctor.
  • For subjects who have had weight-loss surgery (example: gastric banding), the procedure must have occurred at least 1 year ago, and be verified with documentation or by a health professional associated with the surgery.

Exclusion Criteria:

Subjects cannot participate in this research study if they meet any of the following:

  • Have taken another study drug or study device within the past 6 months.
  • Are taking certain prescribed medications including narcotics or opiates.
  • Consistent recent use of insulin.
  • Have had recent major surgery or prolonged bed rest, or planning or likely to undergo any surgery during the research study.
  • Have a history of bleeding disorders or risk factors for excessive blood clotting.
  • Have difficulty giving blood.
  • Have a history of drug and/or alcohol abuse.

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
Experimental: 0.05 mg ZGN-1061 (A)
0.05 mg ZGN-1061 subcutaneous injection once every 3 days
ZGN-1061 is a methionine aminopeptidase 2 inhibitor
Experimental: 0.3 mg ZGN-1061 (B)
0.3 mg ZGN-1061 subcutaneous injection once every 3 days
ZGN-1061 is a methionine aminopeptidase 2 inhibitor
Experimental: 0.9 mg ZGN-1061 (C)
0.9 mg ZGN-1061 subcutaneous injection once every 3 days
ZGN-1061 is a methionine aminopeptidase 2 inhibitor
Experimental: 1.8 mg ZGN-1061 (CC)
1.8 mg ZGN-1061 subcutaneous injection once every 3 days
ZGN-1061 is a methionine aminopeptidase 2 inhibitor
Placebo Comparator: Placebo (D)
Placebo subcutaneous injection once every 3 days
Placebo has the same excipients and appearance as ZGN-1061

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: 12 weeks
12 weeks
Safety and tolerability as assessed by incidence of adverse events
Time Frame: 12 weeks
12 weeks
Safety and tolerability as assessed by change in medication use, vital signs, physical examination findings, mental well-being questionnaires, laboratory evaluations, and electrocardiogram results
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in body weight
Time Frame: 12 weeks
12 weeks
Change in fasting plasma glucose
Time Frame: 12 weeks
12 weeks
Change in insulin
Time Frame: 12 weeks
12 weeks
Change in C-peptide
Time Frame: 12 weeks
12 weeks
Change in proinsulin
Time Frame: 12 weeks
12 weeks
Change in glucagon
Time Frame: 12 weeks
12 weeks
Proportion of subjects achieving HbA1c <7% and ≤6.5%
Time Frame: 12 weeks
12 weeks
Change in beta-cell function
Time Frame: 12 weeks
12 weeks
Change in insulin sensitivity
Time Frame: 12 weeks
12 weeks
Change in preprandial and postprandial glycemic parameters as assessed by a mixed meal tolerance test in a subset of subjects
Time Frame: 12 weeks
12 weeks
Change in waist and hip circumference
Time Frame: 12 weeks
12 weeks
Change in biomarkers relevant to obesity and/or type 2 diabetes
Time Frame: 12 weeks
12 weeks
Change in patient reported outcomes measures
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Chair: Dennis Kim, MD, 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 (Actual)

September 12, 2017

Primary Completion (Actual)

November 12, 2018

Study Completion (Actual)

February 22, 2019

Study Registration Dates

First Submitted

August 7, 2017

First Submitted That Met QC Criteria

August 15, 2017

First Posted (Actual)

August 18, 2017

Study Record Updates

Last Update Posted (Actual)

May 24, 2019

Last Update Submitted That Met QC Criteria

May 22, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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