A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of CX11 Tablets in Patients with Type 2 Diabetes Mellitus

Trial details

Who runs it

Corxel Pharmaceuticals Inc.

Trial code

EU 2025-524514-28-00

Record updated

2026. május 29.

Original description

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 00Read full original descriptionShow less

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of CX11 Tablets in Patients with Type 2 Diabetes Mellitus.

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

Inclusion: 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.

Exclusion: 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).

EU CTIS 2025-524514-28-00