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

Corxel Pharmaceuticals

Status and phase: Begins enrollment this month; Phase 2

Conditions: Type II Diabetes Mellitus

Treatments: Other: Placebo; Drug: CX11

Study type: Interventional

Funder types: Industry

Identifiers

NCT07340320

CX11202

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and 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, with or without a stable dose of an SGLT2 inhibitor, for at least 3 months.
• Individuals who could become pregnant or could father a child must be willing and able to use highly effective birth control.

Exclusion Criteria

Participants who meet any of the following criteria will be excluded from this study:

• 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.
  • 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.
  • Calcitonin ≥ 20 ng/L.
  • Hemoglobin < 110 g/L (male) or < 100 g/L (female).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

240 participants in 6 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Treatment:

Other: Placebo

40 mg group

Experimental group

Treatment:

Drug: CX11

80 mg group

Experimental group

Treatment:

Drug: CX11

120 mg group

Experimental group

Treatment:

Drug: CX11

160 mg group

Experimental group

Treatment:

Drug: CX11

200 mg group

Experimental group

Treatment:

Drug: CX11