Early Phase 1 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:

• People of Chinese background, male or female, aged between 18 and 65 years old
• People who have been diagnosed with type 2 diabetes for at least 3 months but less than 5 years, based on Chinese Diabetes Society guidelines
• People whose blood sugar is not well controlled despite trying diet and exercise alone, or metformin alone, or a stable combination of metformin plus one other diabetes tablet for at least 12 weeks — and whose fasting blood sugar is below 13.0 mmol/L and HbA1c (a measure of average blood sugar) is between 7.5% and 10.0%
• People with a body mass index (BMI — a measure of body weight relative to height) between 18.5 and 40.0 kg/m²
• People who have no plans to become pregnant from the start of the trial until 3 months after the last dose, and who are willing to use at least one reliable form of contraception throughout that period
• People who are able to understand the trial, are willing to sign a consent form, and understand what the trial involves including possible side effects
• People who are able to complete all trial visits and requirements as set out in the study plan

Who may not be able to join:

• People diagnosed with type 1 diabetes, diabetes caused by pancreatic damage, or diabetes linked to other specific conditions such as acromegaly or Cushing's syndrome
• People who have had a serious diabetes-related crisis (such as diabetic ketoacidosis or hyperosmolar coma) in the 6 months before screening
• People who have serious long-term diabetes complications (such as advanced eye disease, severe nerve damage, or diabetic foot problems) that the study doctor considers make participation unsuitable
• People with a history of multiple allergies (to 2 or more drugs or foods), a tendency to develop raised scar tissue (keloids), a known drug allergy, or where the study doctor suspects a possible allergy to the trial medication or similar medicines
• People whose fasting blood sugar dropped below 3.9 mmol/L at screening, or who have had 2 or more severe low blood sugar episodes, or repeated low blood sugar symptoms, in the past 6 months
• People with a history or current diagnosis of Cushing's syndrome, polycystic ovary syndrome, other inherited hormonal conditions, or obesity caused by hormone-related factors
• People who have used weight-loss medications or had weight-loss surgery in the 3 months before screening, or whose weight has changed by more than 5% in that time
• People with significantly abnormal thyroid hormone levels at screening, or a previous diagnosis of thyroid problems that the study doctor considers make participation unsuitable
• People with a personal or family history of a condition called multiple endocrine neoplasia type 2, or medullary thyroid cancer, or who have thyroid nodules classified as suspicious or higher on ultrasound (C-TIRADS category 4 or above)
• People who have had or currently have a malignant cancer (except for certain fully cured skin or cervical conditions)
• People with a history of serious blood clot conditions (such as deep vein thrombosis, pulmonary embolism, or stroke), known bleeding or clotting problems, a major clotting event in the past 6 months, or abnormal clotting results at screening
• People who have used blood-thinning or anti-clotting medications (such as warfarin, rivaroxaban, dabigatran, aspirin, or clopidogrel) for more than 1 month before screening, or who are currently using them
• People who have been diagnosed with a significant heart or stroke-related condition in the 6 months before screening, including acute stroke, mini-stroke (TIA), acute coronary syndrome, coronary heart disease, heart failure, or a heart rhythm problem requiring treatment
• People with a history of gout or a gout attack in the 6 months before screening or before enrolling
• People with uncontrolled or poorly controlled high blood pressure (systolic above 160 mmHg and/or diastolic above 100 mmHg) at screening or before enrolling — people on blood pressure medication must have been on a stable dose for at least 1 month
• People with a resting heart rate below 50 or above 100 beats per minute at screening or before enrolling
• People with certain abnormal heart electrical readings (ECG results), specifically a PR interval above 210 ms, QRS duration above 120 ms, or QTcF above 450 ms
• People with a history of significant ongoing or recurring lung conditions such as asthma or COPD (note: obstructive sleep apnea is not included in this exclusion)
• People with serious stomach or bowel disease (such as active ulcers, gastroparesis, bowel blockage, or inflammatory bowel disease) in the 6 months before screening, or a history of stomach or bowel surgery, or long-term use of medications that affect gut movement due to a chronic bowel condition
• People with severe kidney disease or a kidney filtration rate (eGFR) below 60 mL/min/1.73m² at screening
• People with pancreatic enzyme levels (amylase or lipase) more than 3 times the normal upper limit, or a history of pancreatitis or pancreatic injury
• People with a history of gallstones or gallbladder inflammation, unless the study doctor determines there are no remaining stones and no ongoing effects after treatment or gallbladder removal
• People with severely abnormal cholesterol or fat levels in the blood — specifically LDL-C at or above 4.40 mmol/L or triglycerides at or above 5.65 mmol/L — unless on a stable lipid-lowering medication regimen for at least 1 month
• People with a clear history of a psychiatric condition (such as depression, schizophrenia, or bipolar disorder) in the 2 years before screening
• People who have had major surgery in the month before screening, or who currently have a serious infection or active inflammation
• People who have donated more than 400 mL of blood, received a blood transfusion, or had significant blood loss in the 90 days before screening
• People with certain abnormal blood test results at screening, including: liver enzyme levels (ALT or AST) more than twice the normal upper limit; total bilirubin more than 1.5 times the normal upper limit; calcitonin (a hormone) at or above 35 pg/mL; low haemoglobin (below 110 g/L for females or 120 g/L for males); significantly abnormal platelet count; or significantly abnormal white blood cell or neutrophil count
• People who have used certain medications that can affect body weight in the 3 months before screening, including weight-loss drugs, systemic steroids, certain antidepressants, or certain antipsychotic or mood-stabilising medications (confirm specific medications with trial site)
• People who have used DPP-4 inhibitors, GLP-1, GIP, or GCG receptor agonist medications, or FGF-21, in the 6 months before screening (these include a class of diabetes and weight-related injectable or oral treatments — confirm with trial site if unsure)
• People who have had bariatric (weight-loss) surgery, except those who had liposuction or a tummy tuck more than 1 year before screening
• People who have taken part in another clinical drug or medical device trial in the 3 months before screening or before enrolling
• People who test positive for hepatitis B, hepatitis C, syphilis, or HIV at screening
• People with a history of drug misuse or heavy alcohol use (more than 14 units of alcohol per week) in the 6 months before screening
• People who test positive for drugs or alcohol at screening
• People who are pregnant, breastfeeding, or currently using oral contraceptives
• People who cannot tolerate having blood drawn, or who have a history of fainting from needles or the sight of blood
• People the study doctor considers unsuitable for any other medical, psychological, or personal reason

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