Obesity, Overweight, Type 2 Diabetes
Conditions
Keywords
Long-acting amylin analogues, Weight management
Brief summary
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.
Interventions
DRUGPetrelintide
Petrelintide will be taken by participants once weekly subcutaneously.
OTHERPlacebo
Matching placebo to petrelintide will be taken by participants once weekly subcutaneously.
Sponsors
Zealand Pharma
Parexel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Male or female participants with body mass index (BMI) ≥27.0 kg/m2. * Diagnosed with type 2 diabetes ≥180 days prior to the day of screening. * Treated with metformin with or without sodium-glucose cotransporter 2 inhibitors. Treatment should be stable (same drug\[s\], dose, and dosing frequency) for at least 90 days prior to screening. Main
Exclusion criteria
* Severe hypoglycemia within 6 months prior to screening or history of hypoglycemia unawareness. * Receipt of any other glucose-lowering drug than those listed in the inclusion criterion within 90 days prior to screening. * A self-reported change in body weight \>5% within 90 days prior to screening, irrespective of medical records. * Treatment with any medication (prescribed or over-the-counter) or alternative remedies (herbal or nutritional supplements) intended to promote weight loss within 90 days prior to screening. * Previous or planned (during the trial period) obesity treatment with surgery or a body weight loss device. However, liposuction or surgical removal of fat depots more than 1 year prior to screening or device-based interventions (e.g., sleeve, banding, or similar) that have been removed more than 6 months prior to screening, are allowed. * Obesity due to endocrine disorders or genetic syndromes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage Change in Body Weight | From Baseline (Day 1) to Weeks 28 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Achieving ≥5% Body Weight Loss | From Baseline (Day 1) to Weeks 28 |
| Number of Participants Achieving ≥10% Body Weight Loss | From Baseline (Day 1) to Weeks 28 |
| Change in Body Weight (kilogram) | From Baseline (Day 1) to Weeks 28 |
| Change in Waist Circumference | From Baseline (Day 1) to Weeks 28 |
| Change in Glycated Hemoglobin (HbA1c) | From Baseline (Day 1) to Weeks 28 |
| Change in Fasting Glucose | From Baseline (Day 1) to Weeks 28 |
| Change in High-Sensitivity C-reactive protein (hsCRP) | From Baseline (Day 1) to Weeks 28 |
| Number of Participants Achieving ≤6.5% HbA1c | From Baseline (Day 1) to Weeks 28 |
| Changes in Fasting Lipids | From Baseline (Day 1) to Weeks 28 |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From Baseline (Day 1) to Weeks 38 |
| Number of Participants with Treatment- Emergent Severe or Clinically Significant Hypoglycemic Episodes from Baseline to Week 38 | From Baseline (Day 1) to Weeks 38 |
| Number of Participants with Positive Anti-Drug Antibodies (ADAs) | From Baseline (Day 1) to Weeks 38 |
| Change in Systolic Blood Pressure | From Baseline (Day 1) to Week 38 |
| Change in Diastolic Blood Pressure | From Baseline (Day 1) to Week 38 |
| Change in Pulse Rate | From Baseline (Day 1) to Week 38 |
Countries
United States
Outcome results
None listed