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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of CX11 Tablets in Patients with Type 2 Diabetes Mellitus
EU CTIS ID: 2025-524514-28-00
What this study is testing
To evaluate the effect of different dose levels of CX11 on HbA1C and to demonstrate at least one dose level of CX11 is superior in change from baseline for HbA1c relative to placebo at Week 00
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male and female patients 18 to 75 years (both inclusive) of age 2. Diagnosis of T2DM ≥ 6 months before screening 3. HbA1c 7.0% - 10.5% (both inclusive) 4. BMI 23 - 50 kg/m2 (both inclusive) 5. Have a stable body weight for the 3 months prior to randomization 6. Treatment with stable dose of metformin with or without a stable dose of SGLT2 inhibitor for at least 3 months 7. Participants and their partners must not intend to become pregnant or donate sperm or ova during the study and for 90 days following the last dose. Women of childbearing potential (WOCBP) are required to use highly effective contraception (see section 11.2) for at least 6 months prior to screening, throughout the study, and continuing for 90 days following the last dose. In addition, a negative pregnancy test must be obtained within 24 hours prior to the first dose.
You likely can't join if
- 1. Patients with type 1 diabetes or history of ketoacidosis 2. Exposure to other GLP-1R agonists within 6 months prior to screening, or any previous exposure to CX11 3. Use of insulin for glycemic control within 12 months prior to screening. 4. Have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms within 6 months prior screening. 5. History or evidence of any of the following diseases: Cardiovascular Events; Advanced Heart Failure; Significant ECG Abnormalities; Poorly Controlled Hypertension; Pancreatic and Gallbladder Disorders; Uncontrolled Thyroid Dysfunction; Family or Personal History of Specific Cancers; Recent or Active Malignancy; Serious Chronic Gastrointestinal Diseases; Active liver disease 6. ANY of the following abnormalities in clinical laboratory tests at screening: (1) Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (2) Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2.5 × upper limit of normal (ULN) (3) Total bilirubin (TBIL) > 1.5 × ULN (except for cases of known Gilbert's syndrome) (4) Serum amylase or lipase > 1.5 × ULN (5) Fasting triglycerides (TG) > 5.7 mmol/L (6) Thyroid stimulating hormone (TSH) > 1.5 × ULN (7) Calcitonin ≥20 ng/L (8) Hemoglobin (Hb) < 110 g/L (male) or < 100 g/L (female)
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.