DRUG
Petrelintide
Petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.
Status
Completed
Phase
Phase 2
Enrollment
493
Locations
32
Results
Not posted
Publications
0
Study summary
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.
Interventions
DRUG
Petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.
DRUG
Matching placebo to petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.
Timeline
First posted
Oct 29, 2024
Study start
Dec 9, 2024
Primary completion
Sep 30, 2025
Study completion
Mar 7, 2026
Results posted
Not reported
Registry updated
Mar 23, 2026
Outcomes
Percent change from baseline in body weight to Week 28
Time frame · From Baseline (Day 1) 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.
Percentage of Participants achieving ≥5% Body Weight Loss at Weeks 28 and 42
Time frame · From Baseline (Day 1) 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.
Percentage of Participants achieving ≥10% Body Weight Loss at Weeks 28 and 42
Time frame · From Baseline (Day 1) 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.
Change from baseline in body weight to Weeks 28 and 42
Time frame · From Baseline (Day 1) 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.
Change from baseline in waist circumference to Weeks 28 and 42
Time frame · From Baseline (Day 1) 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.
Percent change from baseline in body weight to Week 42
Time frame · From Baseline (Day 1) 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.
Change from baseline in hemoglobin A1c (HbA1c) to Week 42
Time frame · From Baseline (Day 1) 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.
Change from baseline in fasting glucose to Week 42
Time frame · From Baseline (Day 1) 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.
Change from baseline in high-sensitivity C-reactive protein (hsCRP) to Week 42
Time frame · From Baseline (Day 1) 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.
Change from baseline in fasting lipids to Week 42
Time frame · From Baseline (Day 1) 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.
Number of treatment emergent adverse events (TEAEs)
Time frame · From Baseline (Day 1) to Week 51
To compare the safety and tolerability of petrelintide versus placebo when added as an adjunct to a reduced-calorie diet and increased physical activity.
Eligibility
Inclusion Criteria: * Male or female participants having body mass index (BMI) ≥30.0 kg/m2 or BMI ≥27.0 kg/m2 with the presence of at least one of the following comorbidities: hypertension or dyslipidemia (treated or untreated). * A female participant is eligible to participate if she is: * A woman of nonchildbearing potential. OR * A woman of childbearing potential (WOCBP) who is not pregnant, does not intend to be pregnant, not lactating and is willing to use highly effective contraceptive methods (as required by local regulation or practice) throughout the trial and for 10 weeks after the last injection of the investigational medicinal product (IMP). * Ability to comply with the protocol requirements including self-administration of IMP with vial and syringe. Exclusion Criteria: * Glycated hemoglobin (HbA1c) ≥48 mmol/mol (6.5%), as measured at screening. * History of type 1 or type 2 diabetes mellitus. * Treatment with glucose lowering agent(s) within 90 days prior to screening. * A self-reported change in body weight \>5% within 90 days prior to screening. * Treatment with any medication (prescribed or over-the-counter) or alternative remedies (herbal or nutritional supplements) intended to promote weight loss within 6 months 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. * Uncontrolled thyroid disease defined as thyroid stimulating hormone \>4.20 mIU/L or \<0.27 mIU/L as measured by the central laboratory at screening. * Lifetime history of a suicidal attempt. * History of major depressive disorder or other severe psychiatric disorders (e.g. schizophrenia or bipolar disorder). * Estimated glomerular filtration rate value \<60.0 mL/min/1.73m2, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) Creatinine Equation17, measured at screening. * Impaired liver function, defined as alanine aminotransferase and/or aspartate aminotransferase ≥2.0 times or bilirubin \>1.5 times upper normal limit, measured at screening. * Presence or history of acute or chronic pancreatitis. * Known clinically significant gastric emptying abnormality (for example, severe gastroparesis or gastric outlet obstruction) or chronic treatment that affects gastrointestinal (GI) motility. * Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischemic attack, stroke, cardiac decompensation. * Presence or history of clinically significant arrhythmias or clinically significant conduction disorders. * Known or suspected hypersensitivity to amylin analogs or related products. * History of malignant neoplasms (except for basal or squamous cell skin cancer) within 5 years prior to screening. * Known or suspected abuse of alcohol or recreational drugs. * Participant previously treated with petrelintide or any other amylin analog.
Study locations
Poland · Romania · United States. Showing up to 24 locations stored in the fast local snapshot.
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
CHEAR Center LLC
The Bronx, New York, United States
Javara Inc
Charlotte, North Carolina, United States
PharmQuest Life Sciences, LLC
Greensboro, North Carolina, United States
Lucas Research, Inc.
New Bern, North Carolina, United States
AMR Norman
Norman, Oklahoma, United States
Altoona Center for Clinical Research - Research
Duncansville, Pennsylvania, United States
Alliance for Multispecialty Research
Knoxville, Tennessee, United States
Clinical Trials of Texas, LLC., dba Flourish Research
San Antonio, Texas, United States
Manaasas Clinical Research Center
Manassas, Virginia, United States
Krakowskie Centrum MedyczneSp.z o.o
Krakow, Lesser Poland Voivodeship, Poland
ETG Siedlce
Siedlce, Masovian Voivodeship, Poland
FutureMeds Warszawa Centrum
Warsaw, Masovian Voivodeship, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
Warsaw, Masovian Voivodeship, Poland
ETG Warszawa
Warsaw, Masovian Voivodeship, Poland
Publications
No PMID-linked publications were present in this registry snapshot.
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