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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
188

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • 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
  • New Zealand
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 0.05 mg ZGN-1061 (A)
0.05 mg ZGN-1061 subcutaneous injection once every 3 days
Drug: ZGN-1061
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
Drug: ZGN-1061
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
Drug: ZGN-1061
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
Drug: ZGN-1061
ZGN-1061 is a methionine aminopeptidase 2 inhibitor
Placebo Comparator: Placebo (D)
Placebo subcutaneous injection once every 3 days
Drug: Placebo
Placebo has the same excipients and appearance as ZGN-1061

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zafgen, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 22, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZAF-1061-201
  • U1111-1196-7527 (Registry Identifier: International Clinical Trials Registry Platform)

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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