Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities
NCT ID: NCT06662539
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
493 participants
INTERVENTIONAL
2024-12-09
2026-03-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)
NCT06926842
Efficacy and Safety of Zenoctil in Reducing Body Weight
NCT01423617
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD6234 After Repeat Dose Administration in Participants Who Are Overweight or Obese
NCT06132841
Research Study of a New Medicine (NNC9204-1706) in People With Overweight or Obesity
NCT03661879
Efficacy and Safety of ZT006 in Overweight and Obese Participants
NCT07230132
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Petrelintide Dose 1
Participants will self-inject petrelintide dose 1 subcutaneously once a week.
Petrelintide
Petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.
Petrelintide Dose 2
Participants will self-inject petrelintide dose 2 subcutaneously once a week.
Petrelintide
Petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.
Petrelintide Dose 3
Participants will self-inject petrelintide dose 3 subcutaneously once a week.
Petrelintide
Petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.
Petrelintide Dose 4
Participants will self-inject petrelintide dose 4 subcutaneously once a week.
Petrelintide
Petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.
Petrelintide Dose 5
Participants will self-inject petrelintide dose 5 subcutaneously once a week.
Petrelintide
Petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.
Placebo
Participants will self-inject matching placebo to petrelintide subcutaneously once a week.
Placebo
Matching placebo to petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Petrelintide
Petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.
Placebo
Matching placebo to petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Parexel
INDUSTRY
Zealand Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Futuremeds Olsztyn
Olsztyn, Warmian-Masurian Voivodeship, Poland
Institutul National de Endocrinologie C I Parhon
Bucharest, București, Romania
Institutul Clinic Fundeni
Bucharest, București, Romania
Fundatia Dr Victor Babes
Bucharest, București, Romania
Institutul De Pneumoftiziologie Marius Nasta
Bucharest, București, Romania
Spitalul Clinic Judetean de Urgenta Sf Apostol Andrei Constanta
Constanța, Constanța County, Romania
Top Diabet
Craiova, Dolj, Romania
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-512549-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ZP8396-23094
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.