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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT06010004
Eligibility Criteria:
Inclusion Criteria:
* Have Type 2 Diabetes (T2D)
* Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤10.5% (≤91 mmol/mol) as determined by the central laboratory at screening.
* Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment.
* Have a BMI ≥23.0 kilogram/square meter (kg/m²) at screening.
Exclusion Criteria:
* Have Type 1 Diabetes (T1D).
* Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization.
* Have New York Heart Association functional classification IV congestive heart failure.
* Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization.
* acute myocardial infarction
* cerebrovascular accident (stroke), or
* hospitalization for congestive heart failure
* Have acute or chronic hepatitis and pancreatitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06010004
Study Brief:
Protocol Section:
NCT06010004