Current partner codePEPTIDESDE
NCT06662539·Phase 2·INTERVENTIONAL

Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities

Status

Completed

Phase

Phase 2

Enrollment

493

Locations

32

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

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

Treatment arms and agents.

DRUG

Petrelintide

Petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.

DRUG

Placebo

Matching placebo to petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.

Timeline

From registration to results.

  1. First posted

    Oct 29, 2024

  2. Study start

    Dec 9, 2024

  3. Primary completion

    Sep 30, 2025

  4. Study completion

    Mar 7, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Mar 23, 2026

Outcomes

What the study measures.

Primary 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.

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

32 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Petrelintide.

Related PeptideStat pages

Put the record in context.

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