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

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT06662539

Run by

Zealand Pharma

People needed

493

Starts

2024-12-09

Expected to finish

2026-03-07

Last updated by the study team

2026-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• FutureMeds Targowek — Warsaw, Masovian Voivodeship, Poland

Full record on ClinicalTrials.gov

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