Status:
COMPLETED
Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes
Lead Sponsor:
Zafgen, Inc.
Conditions:
Type 2 Diabetes Mellitus
Overweight and Obesity
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061 in participants with type 2 diabetes.
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2019
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT03254368
Start Date
September 12 2017
End Date
February 22 2019
Last Update
May 24 2019
Active Locations (23)
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1
Coffs Harbour GP SuperClinic
Coffs Harbour, New South Wales, Australia, 2450
2
Northside Health
Coffs Harbour, New South Wales, Australia, 2450
3
The Aim Centre
Merewether, New South Wales, Australia, 2291
4
The Boden Institute
Sydney, New South Wales, Australia, 2006