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 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07351058
Eligibility Criteria:
Inclusion Criteria:
* Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
* Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
* Body mass index (BMI) ≥27.0 kg/m\^2
* History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
Exclusion Criteria:
* History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
* Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
* At least 2 confirmed fasting blood glucose values \>270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
* Self-reported change in body weight \>5 kg within 3 months prior to screening
* Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
* Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
* Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
* Poorly controlled hypertension at screening
* Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure
* Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07351058
Study Brief:
Protocol Section:
NCT07351058