Tirzepatide for Type 1 Diabetes
(TZP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a weekly medication called tirzepatide (an injectable drug) can help people with type 1 diabetes use their insulin pumps more easily without counting carbs at meals. The study will compare two groups: one receiving tirzepatide injections and another continuing their usual therapy. It is ideal for adults with type 1 diabetes who actively count carbs for insulin dosing and use an insulin pump. The goal is to determine if tirzepatide can maintain stable blood sugar levels while simplifying diabetes management. Participants will share data from their glucose monitors and insulin pumps to help researchers evaluate the outcomes.
As a Phase 2 and Phase 3 trial, this study measures how well tirzepatide works in an initial group and evaluates its effectiveness in the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in diabetes management.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that tirzepatide, a drug for type 2 diabetes and weight loss, has been tested for safety in people with type 1 diabetes. In earlier studies, side effects such as nausea and vomiting were common, affecting about 22.4% of participants. However, most participants (91.4%) continued using the medication despite these side effects.
Tirzepatide has already received approval for other uses, suggesting a degree of safety. Nevertheless, researchers closely monitor trial participants for serious risks, such as gallbladder disease or pancreatitis, although these are less common. Overall, while tirzepatide appears promising, more research is needed to fully understand its safety for type 1 diabetes.12345Why are researchers excited about this study treatment for type 1 diabetes?
Tirzepatide is unique because it combines blood sugar control with potential weight management, which is a fresh approach for treating Type 1 Diabetes. Unlike standard treatments like insulin pumps and continuous glucose monitors that primarily focus on maintaining glucose levels, tirzepatide is a dual-action medication. It mimics the effects of both GLP-1 and GIP hormones, which not only help regulate glucose but may also improve metabolic outcomes. Researchers are excited because this could mean better overall health management for patients, potentially reducing the need for strict carbohydrate counting and offering a more comprehensive treatment strategy.
What evidence suggests that tirzepatide might be an effective treatment for type 1 diabetes?
Research shows that tirzepatide, which participants in this trial may receive, may help manage type 1 diabetes. Studies have found it can lower HbA1c, a measure of average blood sugar levels, by up to 0.59% and reduce body weight by up to 10.5%. Beyond aiding weight loss, tirzepatide has been linked to improved blood sugar control. It slows digestion and reduces the need for insulin, helping maintain steady blood sugar levels after meals. Although initially approved for type 2 diabetes, early research suggests it might also make insulin use easier and more effective for people with type 1 diabetes.678910
Who Is on the Research Team?
Melissa-Rosina Pasqua, MD-PhD
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Ahmad Haidar, PhD
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Are You a Good Fit for This Trial?
Adults with type 1 diabetes who are interested in simplifying their insulin pump use by potentially reducing the need to count carbohydrates. Participants will be using a Tandem Control-IQ insulin pump and Dexcom G7 monitor. Key exclusions include pregnancy, history of pancreatitis or gallbladder disease, and other conditions that may interfere with safe participation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tirzepatide or continue standard therapy while using the Tandem Control-IQ insulin pump and Dexcom G7 continuous glucose monitor. Tirzepatide dose is gradually increased over 12 weeks.
Final Treatment Phase
Participants in the tirzepatide group stop entering carbohydrate amounts into the pump for six weeks while continuing tirzepatide at their maintenance dose.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including additional safety follow-up at Week 8 and Week 16 post-study.
What Are the Treatments Tested in This Trial?
Interventions
- Tirzepatide
Trial Overview
The trial is testing tirzepatide, a medication for type 2 diabetes and weight management, to see if it can help those with type 1 diabetes manage blood sugar without counting carbs. The study compares two groups: one receiving weekly tirzepatide injections and another continuing standard care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to this arm receive once-weekly subcutaneous tirzepatide in addition to use of the Tandem Control-IQ insulin pump and Dexcom G7 continuous glucose monitor. Tirzepatide is initiated at 2.5 mg weekly and increased by 2.5 mg every 4 weeks to a target dose of 10 mg weekly or the maximally tolerated dose. Dose escalation may be delayed or reduced if participants experience intolerable gastrointestinal symptoms. During Weeks 1-26, participants continue standard carbohydrate counting for all meals. Beginning in Week 27, participants stop entering carbohydrate amounts into the pump (no meal announcements) for six weeks while continuing tirzepatide at their maintenance dose. Throughout the intervention, participants undergo regular safety assessments, remote glucose data reviews, insulin-pump parameter adjustments as needed, and scheduled in-person visits to monitor metabolic, cardiovascular, and patient-reported outcomes.
Participants randomized to the control arm use the Tandem Control-IQ automated insulin delivery system with the Dexcom G7 continuous glucose monitor, following standard-of-care diabetes management. They continue carbohydrate counting for all meals throughout the 32-week study and deliver prandial insulin boluses based on estimated carbohydrate intake, as is typical for users of hybrid closed-loop systems. No tirzepatide injections are administered. Participants receive the same device training, follow-up schedule, safety monitoring, glucose data reviews, and pump parameter adjustments as the tirzepatide arm. This arm serves as an active comparator, representing current standard therapy for type 1 diabetes with automated insulin delivery and meal announcements.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Melissa-Rosina Pasqua
Lead Sponsor
Institut de Recherches Cliniques de Montreal
Collaborator
Insel Gruppe AG, University Hospital Bern
Collaborator
Breakthrough T1D
Collaborator
Citations
1.
diabetesjournals.org
diabetesjournals.org/care/article/doi/10.2337/dc25-2379/163859/Tirzepatide-in-Adults-With-Type-1-Diabetes-A-PhaseTirzepatide in Adults With Type 1 Diabetes: A Phase 2 ...
In summary, we found that tirzepatide resulted in a greater reduction in weight than placebo among adults with type 1 diabetes and obesity. The ...
Efficacy and Safety of Tirzepatide in Adults With Type 1 ...
There was significant reduction in HbA1c by 0.45% at 3 months and 0.59% at 8 months, and a significant reduction in body weight by 3.4%, 10.5%, ...
Real‐world evaluation of the effects of tirzepatide in patients ...
A recent cost-effectiveness analysis also found tirzepatide to be associated with lower rates of diabetes complications and improved quality- ...
Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes
This study will examine the effects of Tirzepatide (TZP), a glucagon-like peptide 1 (GLP1) - gastric inhibitory peptide (GIP) co-agonist, on metabolism in ...
Effectiveness of Semaglutide and Tirzepatide in ...
We observed weight loss of 9.1% and 21.4% and improved glucose control in semaglutide and tirzepatide users, respectively, after 1 year of off-label use.
6.
diabetesjournals.org
diabetesjournals.org/diabetes/article/74/Supplement_1/305-OR/158741/305-OR-Tirzepatide-in-Type-1-Diabetes-Safety305-OR: Tirzepatide in Type 1 Diabetes—Safety, Tolerability ...
Side effects were reported by 29 participants (32.8%), with nausea or vomiting the most common (22.4%), but 53 participants (91.4%) continued on ...
Efficacy and Safety of Tirzepatide in Adults With Type 1 ...
Tirzepatide significantly reduced HbA1c and body weight in adults with T1D. A randomized controlled trial is needed to establish efficacy and safety of this ...
NCT06914895 | A Study of Tirzepatide (LY3298176) ...
The main purpose of this study is to find out how well and how safely tirzepatide works in adults who have type 1 diabetes and obesity or overweight.
Impact of 1-Year Tirzepatide Use on Glycemic and ...
We do not have any efficacy and safety data on use of tirzepatide in lean or normal weight T1D. Currently, there are also no data on the use ...
10.
emjreviews.com
emjreviews.com/diabetes/news/easd-2025-tirzepatide-shows-early-promise-in-managing-obesity-in-type-1-diabetes/EASD 2025: Tirzepatide Shows Early Promise in Managing ...
a key finding was a near 10% reduction in body weight after 6 months of treatment. this longitudinal, retrospective study reviewed data from 57 ...
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