RecruitingType II Diabetes Mellitus

A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus

Eligible age

18–75 yrs

Accepts

All genders

Locations

17 states

Healthy volunteers

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About this study

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.

Sponsor: Corxel Pharmaceuticals

You may qualify if…

✓ 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

You may not qualify if…

✕ Participants who meet any of the following criteria will be excluded from this study:
✕ Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids).
✕ Type 1 diabetes or a history of diabetic ketoacidosis.
✕ Use of any GLP-1 receptor agonist within the past 6 months, or any prior exposure to CX11.
✕ Use of insulin to control blood sugar within the past 12 months.
✕ More than one episode of severe low blood sugar, with awareness of hypoglycemia symptoms.
✕ Cardiovascular or cerebrovascular conditions within the past 6 months:
✕ Heart attack, coronary angioplasty, or bypass surgery (diagnostic angiography allowed).