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 @ 2:29 PM
Ignite Modification Date:
2025-12-24 @ 2:29 PM
NCT ID:
NCT07215559
Eligibility Criteria:
Inclusion Criteria:
* Have type 2 diabetes
* Have an HbA1c ≥7.5% to ≤10.5% at screening
* Have been treated with any of the following, alone or in combination, for at least 3 months prior to screening
* Diet and exercise
* Stable dose of metformin
* Sodium-glucose cotransporter-2 (SGLT2) inhibitor
* Have had a stable body weight (\<5% body weight gain and/or loss) for the 3 months prior to screening
* Have a BMI of 27 or greater at screening
Exclusion Criteria:
* Have any form of diabetes other than type 2 diabetes
* Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening
* Have any of the following cardiovascular conditions within 3 months prior to screening:
* acute myocardial infarction
* cerebrovascular accident (stroke)
* unstable angina, or
* hospitalization due to congestive heart failure
* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years, exceptions include
* basal or squamous cell skin cancer
* in situ carcinomas of the cervix, or
* in situ prostate cancer
* Have been prescribed any of the following receptor agonists (RA) or their combination for any indication within the last 6 months:
* amylin RA
* dual amylin and calcitonin RA
* glucagon-like peptide-1 receptor (GLP-1) RA
* glucose-dependent insulinotropic peptide (GIP)/GLP-1 RA
* GLP-1/glucagon (GCG) RAs, or
* GIP/GLP-1/GCG RAs
* Have used excluded antihyperglycemic medications within 3 months prior to screening (including, but not limited to, sulfonylureas, dipeptidyl peptidase-4 inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, and meglitinides
* Have used insulin for diabetic control within the prior year (short term use in certain situations allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07215559
Study Brief:
Protocol Section:
NCT07215559