Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-24 @ 7:40 PM
NCT ID:
NCT06937203
Eligibility Criteria:
Inclusion Criteria:
* Obesity, defined as BMI between 30-50 kg/m2, inclusive, with weight at Screening not to exceed 159 kg (350 lbs)
* At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification
* No abnormal finding of clinical relevance at Screening that could adversely impact participant safety during the study or adversely impact study results
* Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later. Participants must not donate sperm or eggs during the study for at least 90 days following the end of the study or last dose of study drug, whichever is later
Exclusion Criteria:
* Self-reported (or documented) weight gain or loss \>5% within 3 months prior to Screening
* Use of GLP-1RAs (liraglutide, semaglutide, etc.) for any indication within 6 months prior to Screening
* Use of non-GLP-1R medications for weight loss within 3 months prior to Screening including but not limited to naltrexone/bupropion, orlistat, phentermine/topiramate and other prescription or over-the-counter medication or supplement taken for weight loss purposes
* Obesity attributable primarily to medication use, endocrinologic or monogenic disorders
* History of prior surgical or device-based therapy for obesity (including endoscopic bariatric procedures)
* Use of medications or therapies strongly associated with weight gain, alterations in body composition, or increase in muscle mass, within 3 months prior to Screening
* Type 1 diabetes mellitus
Note: Additional inclusion/exclusion criteria may apply per protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06937203
Study Brief:
Protocol Section:
NCT06937203