The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061 in participants with type 2 diabetes.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
188
Coffs Harbour GP SuperClinic
Coffs Harbour, New South Wales, Australia
Change in HbA1c
Time frame: 12 weeks
Safety and tolerability as assessed by incidence of adverse events
Time frame: 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
Time frame: 12 weeks
Change in body weight
Time frame: 12 weeks
Change in fasting plasma glucose
Time frame: 12 weeks
Change in insulin
Time frame: 12 weeks
Change in C-peptide
Time frame: 12 weeks
Change in proinsulin
Time frame: 12 weeks
Change in glucagon
Time frame: 12 weeks
Proportion of subjects achieving HbA1c <7% and ≤6.5%
Time frame: 12 weeks
Change in beta-cell function
Time frame: 12 weeks
Change in insulin sensitivity
Time frame: 12 weeks
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Northside Health
Coffs Harbour, New South Wales, Australia
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Merewether, New South Wales, Australia
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Sydney, New South Wales, Australia
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
Pendlebury Research
Sydney, New South Wales, Australia
Q-Pharm
Herston, Queensland, Australia
Griffith University, Gold Coast Campus
Southport, Queensland, Australia
Southern Adelaide Diabetes & Endocrine Services
Daw Park, South Australia, Australia
Eastern Clinical Research Unit (ECRU)
Box Hill, Victoria, Australia
...and 13 more locations
Change in preprandial and postprandial glycemic parameters as assessed by a mixed meal tolerance test in a subset of subjects
Time frame: 12 weeks
Change in waist and hip circumference
Time frame: 12 weeks
Change in biomarkers relevant to obesity and/or type 2 diabetes
Time frame: 12 weeks
Change in patient reported outcomes measures
Time frame: 12 weeks