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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus, Overweight and Obesity

Intervention / Treatment
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* Drug: ZGN-1061
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.05 mg ZGN-1061 (A)<br>0.05 mg ZGN-1061 subcutaneous injection once every 3 days | Drug: ZGN-1061<br>* ZGN-1061 is a methionine aminopeptidase 2 inhibitor<br>|
| Experimental: 0.3 mg ZGN-1061 (B)<br>0.3 mg ZGN-1061 subcutaneous injection once every 3 days | Drug: ZGN-1061<br>* ZGN-1061 is a methionine aminopeptidase 2 inhibitor<br>|
| Experimental: 0.9 mg ZGN-1061 (C)<br>0.9 mg ZGN-1061 subcutaneous injection once every 3 days | Drug: ZGN-1061<br>* ZGN-1061 is a methionine aminopeptidase 2 inhibitor<br>|
| Experimental: 1.8 mg ZGN-1061 (CC)<br>1.8 mg ZGN-1061 subcutaneous injection once every 3 days | Drug: ZGN-1061<br>* ZGN-1061 is a methionine aminopeptidase 2 inhibitor<br>|
| Placebo Comparator: Placebo (D)<br>Placebo subcutaneous injection once every 3 days | Drug: Placebo<br>* Placebo has the same excipients and appearance as ZGN-1061<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | 12 weeks | 
| Safety and tolerability as assessed by incidence of adverse events |  | 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 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | 12 weeks | 
| Change in fasting plasma glucose |  | 12 weeks | 
| Change in insulin |  | 12 weeks | 
| Change in C-peptide |  | 12 weeks | 
| Change in proinsulin |  | 12 weeks | 
| Change in glucagon |  | 12 weeks | 
| Proportion of subjects achieving HbA1c <7% and ≤6.5% |  | 12 weeks | 
| Change in beta-cell function |  | 12 weeks | 
| Change in insulin sensitivity |  | 12 weeks | 
| Change in preprandial and postprandial glycemic parameters as assessed by a mixed meal tolerance test in a subset of subjects |  | 12 weeks | 
| Change in waist and hip circumference |  | 12 weeks | 
| Change in biomarkers relevant to obesity and/or type 2 diabetes |  | 12 weeks | 
| Change in patient reported outcomes measures |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methionine Aminopeptidase 2 Inhibitor, Diabetes Mellitus, Type 2, Blood Glucose, Overweight, Obesity