Phase 1 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:

• Non-smokers who are generally healthy, aged 18 to 55 (for Parts A–E) or 18 to 70 (for Parts F and G), of any gender
• People with a body weight in a certain range relative to their height — specifically a BMI of 19 to 35 (Parts A–E), or a BMI of 30 to 50 (Parts F and G)
• People whose kidneys are working at a sufficient level, as measured by a blood test called eGFR (the exact required level depends on which part of the trial a person is joining — confirm with trial site)
• People whose liver enzyme levels (ALT, AST, and ALP) fall within acceptable ranges on blood tests (the exact limits differ depending on the trial part)
• People whose standard blood, urine, and chemistry test results are within normal ranges, or where any abnormalities are considered not medically significant by the trial doctor (Parts A–E)
• People with a normal heart tracing (ECG), or one where any irregularities are considered not clinically significant by the trial doctor
• Women who could become pregnant must have a negative pregnancy test at the start of the trial and at clinic entry
• Men, and women who could become pregnant, who are sexually active with opposite-sex partners must agree to use contraception methods specified by the trial
• People who the trial doctor considers to be in good general health based on their medical history and a physical examination, including vital signs

Who may not be able to join:

• People who are pregnant or currently breastfeeding
• People with poorly controlled type 2 diabetes, including those with an HbA1c above 10%, those who have used insulin or pioglitazone in the past 90 days, or those with a history of serious diabetes-related complications such as diabetic ketoacidosis or severe low blood sugar episodes (this applies to Part F)
• People with a history of type 2 diabetes diagnosed prior to a certain point (confirm with trial site for exact details)
• People with a history of type 1 diabetes or a related condition called latent autoimmune diabetes of adults (LADA)
• People whose obesity is caused by a hormonal disorder (such as Cushing's syndrome) or a known genetic condition linked to weight gain (such as Prader-Willi syndrome)
• People with a known serious allergic reaction to tirzepatide or any of its ingredients (Part G)
• People with any serious or active physical or mental health condition — including depression — that the trial doctor believes could affect participation or safety
• People who have taken part in another clinical trial within the past 30 days, or within 5 half-lives of the previously studied drug, whichever is longer
• People with current alcohol use that the trial doctor believes could affect their safety or ability to follow the trial requirements
• People with current use of other substances that the trial doctor believes could affect their safety or ability to follow the trial requirements
• People who test positive for HIV, hepatitis B, or hepatitis C
• People with a history of serious drug allergies or drug sensitivities, such as severe allergic reactions or liver damage caused by a medication
• People with a history of heart disease, heart attack, abnormal heart rhythms, heart failure, reduced heart pumping function, a family history of Long QT Syndrome, or an unexplained death of an otherwise healthy person aged 1 to 30 in their family
• People with a history of fainting, heart palpitations, or unexplained dizziness
• People who have an implanted defibrillator or pacemaker
• People with a history of liver disease of any kind, including alcohol-related liver disease, autoimmune liver conditions, medication-related liver damage, or inherited liver disorders
• People with severe stomach ulcers, significant acid reflux disease, or other conditions involving excess stomach acid
• People who have had surgery or medical treatment that permanently changes how their digestive system absorbs food (such as gastric or intestinal surgery)
• People who have received a COVID-19 vaccine within 14 days before joining the trial

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