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New treatment option for Type II Diabetes Mellitus
Official title A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT07340320
What this study is testing
What is CX11?
CX11 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for type ii diabetes mellitus.
Also referred to as VCT220.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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.
You likely can't join 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...
- 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.
See the full eligibility 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...
- Agrees to avoid grapefruit/grapefruit products
- 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...
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Huntsville, Alabama, United States
- Long Beach, California, United States
- Walnut Creek, California, United States
- Melbourne, Florida, United States
- Tampa, Florida, United States
- Winter Park, Florida, United States
- Albany, Georgia, United States
- Fayetteville, Georgia, United States
- Savannah, Georgia, United States
- Thomasville, Georgia, United States
- Chicago, Illinois, United States
- Evansville, Indiana, United States
- Silver Spring, Maryland, United States
- Springfield, Massachusetts, United States
- Pontiac, Michigan, United States
- Edina, Minnesota, United States
- Mankato, Minnesota, United States
- Berlin, New Jersey, United States
- Albuquerque, New Mexico, United States
+ 18 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Huntsville, Alabama, United States; Long Beach, California, United States; Walnut Creek, California, United States; Melbourne, Florida, United States; Tampa, Florida, United States and 32 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.