A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus
ConditionType II Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCorxel Pharmaceuticals
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CX11
- Placebo
Treatment groups
240 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov