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

• Status: Completed
• Trial end date: 2019-02-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zafgen, Inc.
• Treatments: ZGN-1061

Criteria

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.