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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07303556
Eligibility Criteria:
Inclusion Criteria:
* Chronic heart failure with preserved ejection fraction (left ventricular ejection fraction not ≤ 45%)
* Type 2 diabetes mellitus (T2DM) with HbA1c level between ≥7.0% and ≤10.5%
* Ongoing treatment for T2DM (e.g., metformin and/or sulfonylureas, or basal insulin therapy)
* Stable body weight (±5%) for at least 3 months prior to screening
* Body mass index (BMI) ≥ 25 kg/m²
* Possible inclusion of patients with chronic pancreatitis in remission
* Aged 18 years or older, and not older than 75 years
* Both male and female participants
Exclusion Criteria:
* Type 1 diabetes mellitus
* Exacerbation of chronic pancreatitis
* Acute pancreatitis
* Proliferative diabetic retinopathy, diabetic maculopathy, or non-proliferative diabetic retinopathy
* History of bariatric (weight-loss) surgery or conditions associated with delayed gastric emptying
* Acute or chronic hepatitis
* Chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73 m²
* Myocardial infarction or stroke within the past 2 months
* Medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2) in the participant or a first-degree relative
* Use of any other antidiabetic medications (except metformin and/or sulfonylureas and basal insulin) within the past 3 months
* Use of weight loss medications, including over-the-counter drugs, within the past 3 months
* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorders within the past 2 years
* Healthy individuals (no cardiovascular or metabolic disease)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07303556
Study Brief:
Protocol Section:
NCT07303556