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:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT06326060
Eligibility Criteria:
Inclusion Criteria:
* Female of non-childbearing potential, or male.
a. For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male.
* Age 18-75 years (both inclusive) at the time of signing the informed consent.
* History of at least one self-reported unsuccessful dietary effort to lose body weight.
* a) BMI ≥ 27.0 kg/m2 with the presence of at least one weight-related co-morbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
* b) BMI ≥ 30.0 kg/m2.
Exclusion Criteria:
* HbA1c greater than equal to 6.5% (48 millimoles per mole (mmol/mol)) as measured by the central laboratory at screening.
* History of type 1 or type 2 diabetes mellitus.
* Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06326060
Study Brief:
Protocol Section:
NCT06326060