The main purpose of this study is to investigate efficacy and safety of three doses of petrelintide versus placebo in participants with overweight or obesity and type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
221
Petrelintide will be taken by participants once weekly subcutaneously.
Matching placebo to petrelintide will be taken by participants once weekly subcutaneously.
Percentage Change in Body Weight
Time frame: From Baseline (Day 1) to Weeks 28
Number of Participants Achieving ≥5% Body Weight Loss
Time frame: From Baseline (Day 1) to Weeks 28
Number of Participants Achieving ≥10% Body Weight Loss
Time frame: From Baseline (Day 1) to Weeks 28
Change in Body Weight (kilogram)
Time frame: From Baseline (Day 1) to Weeks 28
Change in Waist Circumference
Time frame: From Baseline (Day 1) to Weeks 28
Change in Glycated Hemoglobin (HbA1c)
Time frame: From Baseline (Day 1) to Weeks 28
Change in Fasting Glucose
Time frame: From Baseline (Day 1) to Weeks 28
Change in High-Sensitivity C-reactive protein (hsCRP)
Time frame: From Baseline (Day 1) to Weeks 28
Number of Participants Achieving ≤6.5% HbA1c
Time frame: From Baseline (Day 1) to Weeks 28
Changes in Fasting Lipids
Time frame: From Baseline (Day 1) to Weeks 28
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: From Baseline (Day 1) to Weeks 38
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Number of Participants with Treatment- Emergent Severe or Clinically Significant Hypoglycemic Episodes from Baseline to Week 38
Time frame: From Baseline (Day 1) to Weeks 38
Number of Participants with Positive Anti-Drug Antibodies (ADAs)
Time frame: From Baseline (Day 1) to Weeks 38
Change in Systolic Blood Pressure
Time frame: From Baseline (Day 1) to Week 38
Change in Diastolic Blood Pressure
Time frame: From Baseline (Day 1) to Week 38
Change in Pulse Rate
Time frame: From Baseline (Day 1) to Week 38