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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT06970405
Eligibility Criteria:
Key Inclusion Criteria:
1. Participants with obesity (defined as Body Mass Index (BMI) ≥30 kg/m2) who are otherwise healthy, as defined in the protocol
2. Women must be postmenopausal, as defined in the protocol
3. Serum testosterone within age-adjusted normal range for men at screening
4. The platelet count is within the normal lower and upper laboratory range
Key Exclusion Criteria:
1. Patients diagnosed with Type 1 or Type 2 diabetes, as defined in the protocol
2. History of any severe, non-traumatic bleeding, and or a known pre-existing medical history of a bleeding, as defined in the protocol
3. History of clinically significant cardiovascular (eg, uncontrolled blood pressure), endocrine, respiratory, hepatic, renal, gastrointestinal, hematological, psychiatric, or neurological disease, as defined in the protocol
4. Any malignancy in the last 5 years prior to screening visit, except for non-melanoma skin cancer that have been resected with no evidence of metastatic disease
5. Any chronic active infection or has received anti-Hepatitis C Virus (HCV) treatments within the previous 6 months, as defined in the protocol
6. Antiplatelet therapy (eg clopidogrel, aspirin), anticoagulants (eg, warfarin, heparin, factor Xa inhibitor, or thrombin inhibitors) in the last 90 days or within 5 half-lives of the therapy at screening, whichever is longer
7. Use in the previous 90 days for \>7 consecutive days at screening of anti-obesity medications, anabolic agents, systemic steroids, androgens, estrogens, or progestogens. Chronic stable doses of thyroid hormones in participants with normal thyroid function are allowed
8. For women, current use, or past use in the last 90 days at screening of hormonal replacement or contraceptive therapy
NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT06970405
Study Brief:
Protocol Section:
NCT06970405