- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03254368
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
Conditions
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
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Parkville, Victoria, Australia, 3050
- Royal Melbourne Hospital
-
-
-
-
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Auckland, New Zealand, 2025
- Middlemore Hospital
-
Auckland, New Zealand, 1021
- Optimal Clinical Trials
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Christchurch, New Zealand, 8011
- Christchurch Diabetes Centre
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Christchurch, New Zealand, 8024
- Southern Clinical Trials
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Christchurch, New Zealand, 8140
- Lipid and Diabetes Research Group
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Hamilton, New Zealand, 3206
- Clinical Trials New Zealand Ltd
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Hastings, New Zealand, 4130
- P3 Research Hawkes Bay
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Newtown, New Zealand, 6021
- P3 Research Wellington
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Rotorua, New Zealand, 3010
- Lakeland Clinical Trials
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Tauranga, New Zealand, 3110
- P3 Research Tauranga
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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
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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