A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus
This study is testing whether a new medication called CX11 works and is safe for participants with type 2 diabetes who have not reached good blood sugar control while taking a steady dose of metformin, with or without a steady dose of an SGLT2 inhibitor, for at least 90 days. The study is being done at multiple medical centers. Participants are assigned by chance (randomized) to different groups, and neither the participants nor the study staff know which group they're in (double-blind). The groups are compared side by side (parallel), and some participants will receive inactive pills (placebo) to help measure the true effect of the study drug. After screening, participants will be randomly placed into one of six groups, with equal chances of being in any group. Each group will receive a different dose of CX11 or a placebo. Treatment will last 24 weeks. After that, all participants will have a 2-week follow-up period to check on safety.
⁃ Participants who meet all of the following criteria will be eligible to participate in this study:
• Adults aged 18 to 75.
• Diagnosis of type 2 diabetes for at least 6 months.
• HbA1c between 7.0% and 10.5%.
• Body mass index (BMI) between 23 and 50 kg/m².
• Body weight stable for the past 3 months before joining.
• Stable dose of metformin (≥1000 mg/day), with or without SGLT2i, for ≥3 months.
• Women of childbearing potential (WOCBP): highly effective contraception ≥6 months prior to screening, throughout study, and 90 days post-last dose; negative pregnancy test within 24 hrs of first dose; no intent to donate sperm/ova
• Agrees to avoid grapefruit/grapefruit products