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 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT06703658
Eligibility Criteria:
Inclusion Criteria:
* Japanese men or women, and 18-65 years of age inclusive, at the time of signing the informed consent.
Inclusion Criteria for Part A:
* HbA1c ≤ 6.0%.
* Body weight ≥ 50.0 kg and BMI within the range 18.0-32.0 kg/m2.
Inclusion Criteria for Part B:
* HbA1c ≥ 6.5% and ≤ 10.5%.
* Not on any other diabetic medications.
* Body weight ≥ 60.0 kg and BMI within the range 24.0-35.0 kg/m2
Exclusion Criteria:
* Has a clinically relevant acute or chronic medical condition or disease.
* History of acute pancreatitis and chronic pancreatitis, gallstones.
* Abnormal renal function.
* Known clinically significant gastric emptying abnormality
* Significant hepatic disease.
* Uncontrolled thyroid disease
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06703658
Study Brief:
Protocol Section:
NCT06703658