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

Zafgen

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus; Overweight and Obesity

Treatments: Drug: Placebo; Drug: ZGN-1061

Study type: Interventional

Funder types: Industry

Identifiers

NCT03254368

ZAF-1061-201

U1111-1196-7527 (Registry Identifier)

Details and patient eligibility

About

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

Full 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).

Enrollment: 188 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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188 participants in 5 patient groups, including a placebo group

0.05 mg ZGN-1061 (A)

Experimental group

Description:

0.05 mg ZGN-1061 subcutaneous injection once every 3 days

Treatment:

Drug: ZGN-1061

0.3 mg ZGN-1061 (B)

Experimental group

Description:

0.3 mg ZGN-1061 subcutaneous injection once every 3 days

Treatment:

Drug: ZGN-1061

0.9 mg ZGN-1061 (C)

Experimental group

Description:

0.9 mg ZGN-1061 subcutaneous injection once every 3 days

Treatment:

Drug: ZGN-1061

1.8 mg ZGN-1061 (CC)

Experimental group

Description:

1.8 mg ZGN-1061 subcutaneous injection once every 3 days

Treatment:

Drug: ZGN-1061

Placebo (D)

Placebo Comparator group

Description:

Placebo subcutaneous injection once every 3 days

Treatment:

Drug: Placebo