The main purpose of this study is to compare dose levels of petrelintide versus placebo with regards to effect on body weight, safety, and tolerability.
Obesity is a chronic disease with a rapidly increasing prevalence associated with significant comorbidities. Petrelintide is a long-acting amylin analog in development for weight management. This is a randomized, double-blind, placebo-controlled, parallel-group, multinational, multicenter, dose-finding, Phase 2 clinical trial. The trial will compare 5 doses of once-weekly (OW) subcutaneously administered petrelintide with placebo. This study consists of 3 periods: 1. A screening period of 2-3 weeks 2. A treatment period of 42 weeks 3. A safety follow-up period of 9 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
493
Petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.
Matching placebo to petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.
Percent change from baseline in body weight to Week 28
To compare the dose-response of increasing doses of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity after 28 weeks of exposure.
Time frame: From Baseline (Day 1) to Week 28
Percentage of Participants achieving ≥5% Body Weight Loss at Weeks 28 and 42
To compare the efficacy of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Time frame: From Baseline (Day 1) to Weeks 28 and 42
Percentage of Participants achieving ≥10% Body Weight Loss at Weeks 28 and 42
To compare the efficacy of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Time frame: From Baseline (Day 1) to Weeks 28 and 42
Change from baseline in body weight to Weeks 28 and 42
To compare the efficacy of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Time frame: From Baseline (Day 1) to Weeks 28 and 42
Change from baseline in waist circumference to Weeks 28 and 42
To compare the efficacy of petrelintide versus placebo on waist circumference, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Time frame: From Baseline (Day 1) to Weeks 28 and 42
Percent change from baseline in body weight to Week 42
To compare the efficacy of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity.
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States
Century Research LLC
Miami, Florida, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Great Lakes Clinical Trials LLC dba Flourish Research
Chicago, Illinois, United States
AMR Wichita East
Wichita, Kansas, United States
Alliance For Multispecialty Research, LLC
Lexington, Kentucky, United States
Mercury Street Medical Group, PLLC
Butte, Montana, United States
...and 22 more locations
Time frame: From Baseline (Day 1) to Week 42
Change from baseline in hemoglobin A1c (HbA1c) to Week 42
To compare the efficacy of petrelintide versus placebo on HbA1c, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Time frame: From Baseline (Day 1) to Week 42
Change from baseline in fasting glucose to Week 42
To compare the efficacy of petrelintide versus placebo on fasting glucose, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Time frame: From Baseline (Day 1) to Week 42
Change from baseline in high-sensitivity C-reactive protein (hsCRP) to Week 42
To compare the efficacy of petrelintide versus placebo on hsCRP, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Time frame: From Baseline (Day 1) to Week 42
Change from baseline in fasting lipids to Week 42
To compare the efficacy of petrelintide versus placebo on fasting lipids, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Time frame: From Baseline (Day 1) to Week 42
Number of treatment emergent adverse events (TEAEs)
To compare the safety and tolerability of petrelintide versus placebo when added as an adjunct to a reduced-calorie diet and increased physical activity.
Time frame: From Baseline (Day 1) to Week 51
Occurrences of anti-drug antibodies (ADAs) to petrelintide
To compare the safety and tolerability of petrelintide versus placebo when added as an adjunct to a reduced-calorie diet and increased physical activity.
Time frame: From Baseline (Day 1) to Week 51