A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus (NCT07340320) | Clinical Trial Compass
RecruitingPhase 2
A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus
United States, Poland240 participantsStarted 2026-02-06
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
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
Exclusion Criteria
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 all…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Glycosylated hemoglobin, Type A1C (HbA1c) from baseline