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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT07271251
Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Japanese male or female.
* Age 18 years or above at the time of signing the informed consent.
* Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 90 days prior to day of screening.
* Glycated haemoglobin (HbA1c) of 7.0-10.5 percent (%) (53-91 millimoles per mole \[mmol /mol\]) (both inclusive) at screening.
* Stable daily dose(s) ≥ 60 days before screening with any 1-2 of the following oral antidiabetic drugs (OADs): Sulfonylurea (SU), glinide, thiazolidinedione (TZD), alpha-glucosidase inhibitor (α-GI), sodium-glucose cotransporter 2 (SGLT-2) inhibitor or metformin (effective or maximum tolerated dose as judged by the investigator) according to Japanese labelling.
Exclusion Criteria:
* Known or suspected hypersensitivity to study intervention(s) or related products.
* Previous participation in this study. Participation is defined as signed informed consent.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
* Current participation (i.e., signed informed consent) in any other interventional clinical study.
* Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
* Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
* Previous or planned (during the study period) obesity treatment with surgery or a weight loss device.
* Anticipated initiation or change in concomitant medications for more than 14 consecutive days affecting weight or glucose metabolism.
* Use of any medication with unknown or unspecified content within 90 days before screening.
* Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
* History or presence of pancreatitis (acute or chronic).
* History of major surgical procedures involving the stomach potentially affecting absorption of study products or current presence of gastrointestinal implant.
* Myocardial infarction, stroke, transient ischaemic attack or hospitalization for unstable angina pectoris within 60 days before screening.
* Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.
* Planned coronary, carotid or peripheral artery revascularisation.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified within 90 days before screening or in the period between screening and randomisation.
* Impaired liver function, defined as Alanine Aminotransferase (ALT) ≥ 2.5 times or Bilirubin \>1.5 times upper normal limit at screening.
* Renal impairment with estimated glomerular filtration rate (eGFR) less than (\<) 30 millilitres per minute per meter square (mL/min/1.73 m\^2) as per 2021 Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) formula (by creatinine) at screening.
* Treatment with medication for diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
* Presence or history of malignant neoplasms or in situ carcinomas within 5 years before screening.
* Any episodes of diabetic ketoacidosis within 90 days before screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07271251
Study Brief:
Protocol Section:
NCT07271251