Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes
- Conditions
- Type 2 Diabetes MellitusOverweight and Obesity
- Interventions
- Drug: Placebo
- Registration Number
- NCT03254368
- Lead Sponsor
- Zafgen, Inc.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 188
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.9 mg ZGN-1061 (C) ZGN-1061 0.9 mg ZGN-1061 subcutaneous injection once every 3 days Placebo (D) Placebo Placebo subcutaneous injection once every 3 days 1.8 mg ZGN-1061 (CC) ZGN-1061 1.8 mg ZGN-1061 subcutaneous injection once every 3 days 0.05 mg ZGN-1061 (A) ZGN-1061 0.05 mg ZGN-1061 subcutaneous injection once every 3 days 0.3 mg ZGN-1061 (B) ZGN-1061 0.3 mg ZGN-1061 subcutaneous injection once every 3 days
- Primary Outcome Measures
Name Time Method Safety and tolerability as assessed by incidence of adverse events 12 weeks Change in HbA1c 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
Name Time Method Change in preprandial and postprandial glycemic parameters as assessed by a mixed meal tolerance test in a subset of subjects 12 weeks Change in fasting plasma glucose 12 weeks Change in glucagon 12 weeks Change in beta-cell function 12 weeks Change in insulin sensitivity 12 weeks Change in insulin 12 weeks Change in body weight 12 weeks Proportion of subjects achieving HbA1c <7% and ≤6.5% 12 weeks Change in C-peptide 12 weeks Change in waist and hip circumference 12 weeks Change in patient reported outcomes measures 12 weeks Change in proinsulin 12 weeks Change in biomarkers relevant to obesity and/or type 2 diabetes 12 weeks
Trial Locations
- Locations (23)
Optimal Clinical Trials
🇳🇿Auckland, New Zealand
Wellington Hospital
🇳🇿Wellington, New Zealand
Coffs Harbour GP SuperClinic
🇦🇺Coffs Harbour, New South Wales, Australia
The Boden Institute
🇦🇺Sydney, New South Wales, Australia
Barwon Health
🇦🇺Geelong, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Eastern Clinical Research Unit (ECRU)
🇦🇺Box Hill, Victoria, Australia
Holdsworth House Medical Practice
🇦🇺Sydney, New South Wales, Australia
The Aim Centre
🇦🇺Merewether, New South Wales, Australia
Northside Health
🇦🇺Coffs Harbour, New South Wales, Australia
Pendlebury Research
🇦🇺Sydney, New South Wales, Australia
Griffith University, Gold Coast Campus
🇦🇺Southport, Queensland, Australia
Q-Pharm
🇦🇺Herston, Queensland, Australia
Lipid and Diabetes Research Group
🇳🇿Christchurch, New Zealand
Clinical Trials New Zealand Ltd
🇳🇿Hamilton, New Zealand
Southern Adelaide Diabetes & Endocrine Services
🇦🇺Daw Park, South Australia, Australia
Christchurch Diabetes Centre
🇳🇿Christchurch, New Zealand
Middlemore Hospital
🇳🇿Auckland, New Zealand
P3 Research Wellington
🇳🇿Newtown, New Zealand
Southern Clinical Trials
🇳🇿Christchurch, New Zealand
Lakeland Clinical Trials
🇳🇿Rotorua, New Zealand
P3 Research Tauranga
🇳🇿Tauranga, New Zealand
P3 Research Hawkes Bay
🇳🇿Hastings, New Zealand