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 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT07224334
Eligibility Criteria:
Aim 2A: Inclusion Criteria:
* age 18-45
* Body Mass Index (BMI) \< 27.0
* Fasting plasma glucose of ≤ 95 mg/dL or HbA1c value ≤ 5.8% as measured at screening visit
Exclusion Criteria:
* Active medical disease: e.g. active infectious, inflammatory, neurodegenerative or mental health disorders
* Personal history of diabetes or pancreatitis
* Personal history of cardiac, gastrointestinal, renal or liver disease
* Immediate family history of diabetes
* Renal insufficiency (eGFR \< 60 mL/kg/min)
* Anemia (hematocrit \< 34%) as measured at screening visit
* Pregnant females
* Consumption of daily medications that alter glucose metabolism of GI function (glucocorticoids, psychotropics, narcotics, metoclopramide)
* Apparent sensitivity to the study peptide as determined by the skin test
Aim 2B: Inclusion Criteria:
* Age 35-60
* Body Mass Index (BMI) 27.0-35
* Fasting plasma glucose of \< 125 mg/dL or HbA1c value \< 6.5% as measured at screening visit
Exclusion Criteria:
* Active medical disease: e.g. active infectious, inflammatory, neurodegenerative or mental health disorders
* Personal history of diabetes or pancreatitis
* Personal history of cardiac, gastrointestinal, renal or liver disease
* Immediate family history of diabetes
* Renal insufficiency (eGFR \< 60 mL/kg/min)
* Anemia (hematocrit \< 34%) as measured at screening visit
* Pregnant females
* Consumption of daily medications that alter glucose metabolism of GI function (glucocorticoids, psychotropics, narcotics, metoclopramide)
* Apparent sensitivity to the study peptide as determined by the skin test
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07224334
Study Brief:
Protocol Section:
NCT07224334