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CX11 tablets for adults with type 2 diabetes

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

Phase 2 Interventional Corxel Pharmaceuticals · NCT07340320

This study will test whether CX11 tablets help adults with type 2 diabetes who are on stable metformin (with or without an SGLT2 inhibitor) improve blood sugar control and are safe.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorCorxel Pharmaceuticals Industry-sponsored
Locations46 sites (Birmingham, Alabama and 45 other locations)
Trial IDNCT07340320 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase 2 trial assigns adults with type 2 diabetes on stable metformin (with or without an SGLT2 inhibitor) to one of six groups receiving different doses of CX11 or placebo. Treatment lasts 24 weeks with an additional 2-week safety follow-up, and key outcomes include changes in HbA1c, fasting plasma glucose, and body weight. Eligible participants are 18–75 years old with HbA1c 7.0–10.5% and BMI 23–50 kg/m² who have had stable weight and medication doses for at least three months. The trial is conducted at multiple clinical research sites in Alabama and uses equal randomization to compare dose-response and safety across groups.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 with type 2 diabetes for at least six months, HbA1c 7.0–10.5%, BMI 23–50 kg/m², on a stable dose of metformin (≥1000 mg/day) with or without an SGLT2 inhibitor for at least three months, and who meet contraception requirements if applicable.

Not a fit: Patients with type 1 diabetes, HbA1c outside the 7.0–10.5% range, recent unstable weight, use of other glucose- or weight-altering medications, pregnancy or breastfeeding, or inability to attend the Alabama study sites are unlikely to benefit from joining.

Why it matters

Potential benefit: If successful, CX11 could provide an additional oral option to lower HbA1c and possibly improve fasting glucose or body weight for people with type 2 diabetes not fully controlled on metformin.

How similar studies have performed: Other oral diabetes agents have shown HbA1c and fasting glucose benefits in Phase 2 trials, but CX11 itself appears to be a novel agent and has not yet been proven effective in larger studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 allowed).
  * Valvular heart disease or prior heart valve repair surgery.
  * Unstable angina.
  * Transient ischemic attack (TIA) or stroke.
  * Decompensated heart failure (NYHA Class III or IV).
  * ECG abnormalities indicating significant safety risk, such as supraventricular tachycardia, torsades de pointes, second- or third-degree AV block, myocardial infarction, QTcF \> 450 ms in males or \> 470 ms in females, PR interval \> 220 ms.
  * Poorly controlled hypertension at screening: systolic ≥ 180 mmHg or diastolic ≥ 100 mmHg.
* Pancreatic or gallbladder conditions:

  * Acute or chronic pancreatitis.
  * Symptomatic gallbladder disease (previous cholecystectomy is allowed).
  * Pancreatic injury or risk factors that increase pancreatitis risk.
* Thyroid conditions:

  * Poorly controlled abnormal thyroid function on a stable dose before screening.
  * Clinically significant abnormal thyroid test results at screening.
  * Personal or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type 2A or 2B.
* Cancer history:

  * Malignancy within the past 5 years, regardless of recurrence or metastasis. Exceptions: localized basal cell skin cancer, low-risk prostate cancer, cervical carcinoma in situ, or high-grade prostatic intraepithelial neoplasia.
* Gastrointestinal conditions or treatments that may affect drug absorption:

  * Abnormal gastric emptying (e.g., gastric outlet obstruction).
  * Severe chronic gastrointestinal disease, including active ulcer within 6 months.
  * Crohn's disease, ulcerative colitis, or other inflammatory bowel diseases.
  * Prior gastrointestinal surgery (except polypectomy and appendectomy).
  * Long-term use of drugs that directly affect gastrointestinal motility (e.g., mosapride, cisapride).
* Liver disease:

  * Active liver disease other than nonalcoholic fatty liver.
  * Chronic active hepatitis B or C.
  * Primary biliary cirrhosis.
* Eye disease:

  * Uncontrolled or potentially unstable diabetic retinopathy or maculopathy.
* Abnormal lab results at screening:

  * eGFR \< 60 mL/min/1.73 m² (CKD-EPI).
  * ALT or AST \> 2.5 × upper limit of normal (ULN).
  * Total bilirubin \> 1.5 × ULN (except known Gilbert's syndrome).
  * Serum amylase or lipase \> 1.5 × ULN.
  * Fasting triglycerides \> 5.7 mmol/L.
  * TSH \> 1.5 × ULN or \< 1.0 × LLN.
  * Calcitonin ≥ 20 ng/L.
  * Hemoglobin \< 110 g/L (male) or \< 100 g/L (female).

Where this trial is running

Birmingham, Alabama and 45 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Type II Diabetes MellitusType 2 Diabetes MellitusHbA1CPercentage change in HbA1CChange in Fasting Plasma GlucoseChange in body weightBody weight lossHypoglycemics episodes
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.