Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities (NCT06662539) | Clinical Trial Compass
CompletedPhase 2
Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities
United States493 participantsStarted 2024-12-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 interv…
What they're measuring
1
Percent change from baseline in body weight to Week 28