Phase 2 Type 2 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 18 and 75 years of age.
• People who have been diagnosed with type 2 diabetes for at least 6 months.
• People whose HbA1c (a measure of average blood sugar over time) is between 7.0% and 10.5%.
• People whose body mass index (BMI) falls between 23 and 50 kg/m².
• People whose body weight has been stable for at least 3 months before joining.
• People who have been taking metformin at a dose of at least 1000 mg per day for 3 or more months, with or without a type of diabetes medication called an SGLT2 inhibitor.
• Women who could potentially become pregnant must have been using highly effective contraception for at least 6 months before screening, must continue using it throughout the study and for 90 days after the last dose, must have a negative pregnancy test within 24 hours of the first dose, and must not intend to donate eggs.
• People who agree to avoid eating grapefruit or consuming grapefruit products during the trial.

Who may not be able to join:

• People who are expected to start or change a medication (for more than 14 days in a row) that is known to affect weight or blood sugar — such as orlistat, thyroid hormones, or steroid medications taken throughout the body.
• People who have type 1 diabetes or have ever had a serious diabetes complication called diabetic ketoacidosis.
• People who have used a class of diabetes medication called a GLP-1 receptor agonist in the past 6 months, or who have previously been given the trial drug CX11.
• People who have used insulin to manage their blood sugar at any point in the past 12 months.
• People who have had more than one episode of severely low blood sugar while still being aware of hypoglycaemia symptoms.
• People who have experienced certain heart or blood vessel conditions in the past 6 months, including: a heart attack, heart stenting, or bypass surgery; heart valve disease or prior valve surgery; unstable chest pain (angina); a mini-stroke (TIA) or stroke; severe heart failure; or certain abnormal heart rhythm readings on an ECG, including a heart rate that is too fast, dangerous irregular rhythms, certain types of electrical blockages in the heart, signs of a prior heart attack on ECG, abnormal electrical interval measurements (QTcF above 450 ms in males or 470 ms in females, or PR interval above 220 ms) (confirm with trial site).
• People with poorly controlled high blood pressure at the time of screening, meaning a reading of 180 mmHg or higher (top number) or 100 mmHg or higher (bottom number).
• People with pancreas or gallbladder problems, including inflammation of the pancreas (acute or chronic), active gallbladder symptoms (though having had the gallbladder removed is allowed), or pancreatic injury or conditions that raise the risk of pancreas inflammation.
• People with thyroid problems that are not well controlled, significantly abnormal thyroid blood test results at screening, or a personal or close family history of a type of thyroid cancer called medullary thyroid carcinoma, or a condition called multiple endocrine neoplasia type 2A or 2B.
• People who have had a cancer diagnosis in the past 5 years — with some exceptions, including certain low-risk or localised skin, prostate, or cervical conditions (confirm with trial site).
• People with certain stomach or bowel conditions or prior surgeries that could affect how the body absorbs the trial medication, including abnormal stomach emptying, severe ongoing digestive disease, a stomach ulcer within the past 6 months, Crohn's disease, ulcerative colitis, other inflammatory bowel diseases, or prior gut surgery (removal of polyps or the appendix is allowed). Also excluded are people who regularly use medications that affect gut movement, such as mosapride or cisapride.
• People with active liver disease (other than fatty liver disease not related to alcohol), ongoing hepatitis B or C infection, or a liver condition called primary biliary cirrhosis.
• People with diabetic eye disease that is unstable or not well controlled.
• People whose blood test results at screening fall outside acceptable ranges, including: reduced kidney function (eGFR below 60); elevated liver enzymes (ALT or AST more than 2.5 times the normal upper limit); elevated bilirubin (more than 1.5 times the normal upper limit, unless a harmless condition called Gilbert's syndrome is already known); elevated pancreatic enzymes (amylase or lipase more than 1.5 times the upper limit); very high fasting triglycerides (above 5.7 mmol/L); thyroid hormone levels outside the acceptable range; a calcitonin level of 20 ng/L or above; or low haemoglobin (below 110 g/L in males or below 100 g/L in females).

Important: Always verify eligibility with the trial site directly before applying.