Overweight and Obesity, Type 2 Diabetes Mellitus
Conditions
Keywords
Methionine Aminopeptidase 2 Inhibitor, Diabetes Mellitus, Type 2, Blood Glucose, Overweight, Obesity
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 mg of ZGN-1061 or placebo (Group 2).
Interventions
DRUGZGN-1061
ZGN-1061 is a methionine aminopeptidase 2 inhibitor
DRUGPlacebo
Placebo has the same excipients and appearance as ZGN-1061
Sponsors
Zafgen, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Change in HbA1c | 12 weeks |
| Safety and tolerability as assessed by incidence of adverse events | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 body weight | 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 |
| Change in insulin sensitivity | 12 weeks |
| Change in fasting plasma glucose | 12 weeks |
| Change in insulin | 12 weeks |
Countries
Australia, New Zealand
Outcome results
None listed