Phase 3 Type 1 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 who have been diagnosed with Type 1 diabetes for at least 12 months.
• People aged between 18 and 65 years old (inclusive).
• People who have been using an automated insulin delivery (AID) system for at least 3 months.
• People whose HbA1c (a measure of average blood sugar over time) is between 6.5% and 10%.
• People with a BMI of 23 or higher.
• People willing to take a once-weekly injection called tirzepatide for at least 16 weeks.
• People willing to wear a Dexcom G7 continuous glucose sensor and share data from their diabetes devices.
• People willing not to start any new non-insulin blood sugar–lowering medications or supplements during the trial (confirm with trial site for the full list).
• People whose weight has been stable (within 5%) for at least the past 90 days, and who agree not to start a new weight-loss diet or exercise program during the study.
• People who are willing to use reliable contraception during the trial, if applicable (confirm with trial site for specific guidelines).
• People who understand the study procedures and are willing to follow them, and who have signed a consent form.

Who may not be able to join:

• People who have been hospitalised for a serious diabetes-related complication called diabetic ketoacidosis in the past 6 months.
• People who have had a severe low blood sugar episode involving a seizure or loss of consciousness in the past 6 months.
• People with uncontrolled diabetic eye disease (retinopathy or maculopathy).
• People with severe gastroparesis (a condition where the stomach empties very slowly).
• People who have been on insulin for less than 12 months.
• People whose kidneys are not functioning well enough, based on a specific blood test result (confirm with trial site).
• People who are pregnant or planning to become pregnant during the trial.
• People who are currently breastfeeding or planning to breastfeed.
• People with a seizure disorder that is currently not well controlled.
• People with a known allergy to the study drug (tirzepatide) or its ingredients.
• People with a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a condition called Multiple Endocrine Neoplasia type 2 (MEN-2).
• People with a specific thyroid-related blood test result (calcitonin) above a certain level at the screening visit.
• People who have surgery planned during the trial period.
• People with high blood pressure that is not well controlled (confirm with trial site for specific values and medication requirements).
• People who have had a serious heart or stroke-related event (such as a heart attack, stroke, unstable chest pain, or hospitalisation for heart failure) within the two months before screening.
• People with conditions that significantly increase the risk of dangerously low blood sugar, such as severe heart failure or adrenal insufficiency.
• People with a documented history of HIV infection.
• People with an uncontrolled irregular heart rhythm, based on a heart tracing (ECG) done at screening.
• People with cystic fibrosis.
• People who have previously had weight-loss (bariatric) surgery, including gastric bypass, sleeve gastrectomy, or gastric banding.
• People with thyroid disease that is not well controlled, as assessed by the study doctor.
• People with very high triglyceride (blood fat) levels at screening, above a certain threshold (confirm with trial site for specific values and medication requirements).
• People with a history of pancreatitis (inflammation of the pancreas), unless it was caused by gallstones and the gallbladder has since been surgically removed.
• People with active or ongoing hepatitis (liver inflammation), other than a specific condition called MASLD.
• People with a history of gallbladder disease symptoms in the past two years, unless the gallbladder has been surgically removed.
• People with a history of cancer requiring treatment in the past five years (certain minor skin cancers and some early-stage cancers may be exceptions — confirm with trial site).
• People with active or unstable major depression, severe psychiatric conditions, eating disorders, or substance misuse that the study doctor believes would prevent safe participation.
• People currently taking non-insulin blood sugar–lowering medications other than metformin (at a stable dose for 30 days before the study).
• People who have used weight-loss medications in the past 3 months.
• People who have received ongoing high-dose steroid (corticosteroid) treatment in the three months before screening (certain forms such as creams or inhalers may be exceptions — confirm with trial site).
• People currently taking or recently having taken medications that significantly affect blood sugar levels (confirm with trial site).
• People who have taken an experimental drug recently (within a timeframe depending on the specific drug — confirm with trial site).
• People who have participated in another drug trial within the 30 days before or during this study (unless specific approval is given by both study teams and the other trial is a non-interventional registry).
• People currently enrolled in another clinical trial, unless both study investigators have approved the overlap and the other trial does not involve an experimental treatment.
• People with a significant uncontrolled medical condition that the study doctor believes could make participation unsafe or affect the study results.
• The trial investigators themselves, their family members, employees, or anyone financially dependent on them.

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