NCT07284511 A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar
| NCT ID | NCT07284511 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2026-05-19 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 105 participants in total. It began in 2026-05-19 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This research study is testing whether a weekly medication called tirzepatide can help adults with type 1 diabetes use their insulin pump more easily, specifically by reducing or eliminating the need to count carbohydrates at meals. People with type 1 diabetes must take insulin for life, and even with advanced insulin pumps and continuous glucose monitors, many still struggle to keep blood sugar within the target range. One of the biggest challenges is carbohydrate counting, which requires estimating the amount of carbohydrates in every meal to give the correct insulin dose. Tirzepatide is a medication currently approved for type 2 diabetes and weight management. Early research suggests it may also help people with type 1 diabetes by lowering appetite, slowing digestion, reducing insulin needs, and smoothing after-meal blood sugar rises. This study will include 105 adults with type 1 diabetes at centers in Canada and Switzerland. Everyone will use the Tandem Control-IQ insulin pump with a Dexcom G7 continuous glucose monitor. Participants are randomly assigned to one of two groups: Tirzepatide group: Participants receive weekly tirzepatide injections. After the dose is gradually increased over 12 weeks, they will eventually try using their insulin pump without entering carbohydrate amounts at meals. Control group: Participants continue their usual therapy and keep counting carbohydrates for their mealtime insulin doses. The main goal of the study is to learn whether people taking tirzepatide can safely maintain good blood sugar control without counting carbs, compared with standard care. All participants will attend several clinic visits and share their glucose, insulin, and health data throughout the 32-week trial. Some centers will also conduct heart/fitness, or body-composition tests. As with any medication, tirzepatide may cause side effects such as nausea, vomiting, diarrhea, or decreased appetite. Rare but serious risks like gallbladder disease or pancreatitis are also monitored. Pregnancy must be avoided during the trial. Overall, this study aims to understand whether adding tirzepatide to automated insulin delivery can simplify diabetes management, reduce burden, and maintain safe and effective glucose control for adults living with type 1 diabetes.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years. * Clinical diagnosis of type 1 diabetes for ≥ 1 year, per investigator judgment (confirmatory C-peptide and autoantibodies not required). * A BMI ≥ 27 kg/m2. * HbA1c \> 6.5%, and \< 12%. * Current therapy: multiple daily injections or insulin pump. * Willingness to use Tandem Control IQ insulin pump system with the use of rapid or ultra rapid-acting insulins compatible with Tandem Control-IQ pump (e.g. Fiasp is not compatible) * Active carbohydrate counting for prandial insulin dosing. * Individuals of childbearing potential must be using or agree to use an effective birth-control method. Childbearing potential refers to participants of the female sex post-menarche who have not reached menopause and who do not have a medical condition causing sterility (e.g., hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause. Exclusion Criteria: * Use of GLP1-RAs within the last four weeks. * Use of antihyperglycemic agents other than insulin or metformin within the last 2 weeks. * Planned or ongoing pregnancy. * Breastfeeding. * Severe hypoglycemia requiring hospitalization in the past 2 months. Severe hypoglycemia is defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions. * Diabetic ketoacidosis within the last 2 months. * History of acute or chronic pancreatitis. * Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2. * Severe renal impairment with eGFR \<30 mL/min/1.73 m2 (CKD-EPI), measured within the last four months. * Clinically significant proliferative diabetic retinopathy or gastroparesis, as per the judgment of the investigator. * Current or ≤ 1 month use of supraphysiological doses of oral or intravenous glucocorticoids. * History of bariatric surgery within the last 6 months. * Medical or psychiatric illness likely to interfere with participation (e.g. cirrhosis, active cancer, decompensated schizophrenia), per investigator judgment. * Inability or unwillingness to comply with safe diabetes management practices, in the view of the investigator. * Any safety concern that, in the investigator's judgment, precludes participation.
Contact & Investigator
Melissa-Rosina Pasqua, MD, PhD
PRINCIPAL INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Frequently Asked Questions
Who can join the NCT07284511 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07284511 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07284511 currently recruiting?
Yes, NCT07284511 is actively recruiting participants. Contact the research team at keddy.moise@mail.mcgill.ca for enrollment information.
Where is the NCT07284511 trial being conducted?
This trial is being conducted at Montreal, Canada, Montreal, Canada, Montreal, Canada, Bern, Switzerland.
Who is sponsoring the NCT07284511 clinical trial?
NCT07284511 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The principal investigator is Melissa-Rosina Pasqua, MD, PhD at McGill University Health Centre/Research Institute of the McGill University Health Centre. The trial plans to enroll 105 participants.
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