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:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT06370728
Eligibility Criteria:
Inclusion Criteria:
* Participants must be overtly healthy individuals, assigned male at birth (AMAB) or individuals not of childbearing potential (INOCBP).
* Have a body weight equal to or greater than 45 kg, and body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²), inclusive, at screening.
* Have a hemoglobin level of
* at least 11.4 g/dL for individuals assigned female at birth (AFAB) and
* at least 12.5 g/dL for AMAB.
* Have venous access sufficient to allow for blood sampling.
Exclusion Criteria:
* Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking orforglipron; or of interfering with the interpretation of data.
* Have an abnormal 12-lead electrocardiogram (ECG).
* Have human leucocyte antigen-B (HLA-B)\*1502 or HLA-A\*3101 allele; participants with other alleles that demonstrate strong evidence of association with carbamazepine-induced hypersensitivity reaction or hepatic impairment may also be excluded.
* Have a history or presence of multiple or severe allergies, or severe post treatment hypersensitivity reactions.
* Have known allergies to carbamazepine or to orforglipron, related compounds, or any components of the formulation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT06370728
Study Brief:
Protocol Section:
NCT06370728