Weekly shot shows promise for shedding pounds in obesity trial
NCT ID NCT06662539
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new weekly injection called petrelintide to help people with obesity or overweight (plus related health issues) lose weight. About 493 participants received either the drug or a placebo, along with diet and exercise advice, for 28 weeks. The main goal was to see how much weight they lost and if the drug was safe.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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493 people
The number who actually took part.
- Started
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Dec 2024
- Finished
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Mar 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AMR Norman
Norman, Oklahoma, 73069, United States
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AMR Wichita East
Wichita, Kansas, 67226, United States
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Alliance For Multispecialty Research, LLC
Lexington, Kentucky, 40509, United States
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Alliance for Multispecialty Research
Knoxville, Tennessee, 37909, United States
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Altoona Center for Clinical Research - Research
Duncansville, Pennsylvania, 16635, United States
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CHEAR Center LLC
The Bronx, New York, 10455, United States
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Century Research LLC
Miami, Florida, 33155, United States
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Clinical Research Center of Florida
Pompano Beach, Florida, 33060-6977, United States
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Clinical Trials of Texas, LLC., dba Flourish Research
San Antonio, Texas, 78229, United States
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ETG Siedlce
Siedlce, Masovian Voivodeship, 08-110, Poland
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ETG Warszawa
Warsaw, Masovian Voivodeship, 02-677, Poland
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Excel Medical Clinical Trials, LLC
Boca Raton, Florida, 33434, United States
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Fundatia Dr Victor Babes
Bucharest, 030303, Romania
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FutureMeds Targowek
Warsaw, Masovian Voivodeship, 03-291, Poland
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FutureMeds Warszawa Centrum
Warsaw, Masovian Voivodeship, 00-215, Poland
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Futuremeds Olsztyn
Olsztyn, Warmian-Masurian Voivodeship, 10-165, Poland
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Great Lakes Clinical Trials LLC dba Flourish Research
Chicago, Illinois, 60640, United States
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Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
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Institutul Clinic Fundeni
Bucharest, 022328, Romania
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Institutul De Pneumoftiziologie Marius Nasta
Bucharest, 050159, Romania
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Institutul National de Endocrinologie C I Parhon
Bucharest, 011863, Romania
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Javara Inc
Charlotte, North Carolina, 28210, United States
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Krakowskie Centrum MedyczneSp.z o.o
Krakow, Lesser Poland Voivodeship, 31-501, Poland
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Lucas Research, Inc.
New Bern, North Carolina, 28562, United States
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Manaasas Clinical Research Center
Manassas, Virginia, 20110, United States
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Mercury Street Medical Group, PLLC
Butte, Montana, 59701, United States
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Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
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Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
Warsaw, Masovian Voivodeship, 02-507, Poland
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PharmQuest Life Sciences, LLC
Greensboro, North Carolina, 27408, United States
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Spitalul Clinic Judetean de Urgenta Sf Apostol Andrei Constanta
Constanța, 900591, Romania
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Top Diabet
Craiova, Dolj, 200515, Romania
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University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
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Other studies related to the condition(s) this trial covers.
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