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

The primary objective is to evaluate the effect of various dose levels of CX11 on HbA1c in patients with type 2 diabetes mellitus. This study aims to demonstrate that at least one dose level of CX11 is superior to placebo in terms of the change from baseline for HbA1c. Secondary objectives include:

• Evaluation of glucose control, body weight, and blood pressure;
• Assessment of tolerability and safety;
• Characterization of the pharmacokinetics of CX11.

This study involves 119 participants diagnosed with type 2 diabetes mellitus. The study population consists of male and female patients aged 18 to 75 years. Eligible individuals must have a diagnosis for at least six months and present with an HbA1c level between 7.0% and 10.5%. Inclusion criteria require a body mass index between 23 and 50 kg/m2 and a stable body weight for the three months preceding randomization. Participants are required to be on a stable dose of metformin, with or without a stable dose of an SGLT2 inhibitor, for a minimum of three months. Additionally, participants must adhere to specific contraceptive requirements and avoid pregnancy or sperm and ova donation during the study and for 90 days following the final dose.

This multicenter, randomized, double-blind, placebo-controlled, dose-finding study is designed to evaluate the efficacy and safety of CX11 in patients diagnosed with type 2 diabetes mellitus. The primary objective is to assess the effect of various dose levels of CX11 on HbA1c compared to a placebo. The methodology involves a Phase 2 clinical trial design to determine at least one dose level that demonstrates superiority in the change from baseline for HbA1c. Study participants will undergo a screening visit to verify eligibility based on specific clinical criteria, including age, body mass index, and stable medication regimens. Following screening, subjects will be randomized to receive either CX11 tablets or a placebo. The trial aims to monitor several secondary endpoints, such as time in range measured by continuous glucose monitoring, fasting plasma glucose, and changes in body weight. The total duration of the study is estimated to span from May 2026 to February 2027.

The experimental medication is CX11, which contains the active substance cx11 trometamol monohydrate. This substance is administered in the form of an oral tablet.

The control group receives a placebo, which is used as a comparator for both the 40 mg and 80 mg dose levels of CX11.

The efficacy of CX11 in patients with type 2 diabetes mellitus is assessed using several parameters. The primary endpoint is the change in HbA1c from baseline. Secondary endpoints include the proportion of subjects achieving HbA1c levels below 7.0% and 6.5%, respectively. Additional assessments involve the change in time in range measured via continuous glucose monitoring from baseline, as well as the change in fasting plasma glucose. The evaluation of body weight includes changes in weight from baseline, percentage change in weight, and the occurrence of weight loss greater than or equal to 5% or 10%.

Further efficacy and clinical assessments consist of the following:

• Change in systolic blood pressure and diastolic blood pressure from baseline.
• Frequency of level 2 hypoglycemic episodes or severe hypoglycemic episodes.
• Analysis of population pharmacokinetic parameters.