Groundbreaking Trial Testing Tirzepatide for Type 1 Diabetes
For the first time, researchers are exploring the effectiveness of tirzepatide – which is currently only approved for type 2 diabetes – for people with type 1 diabetes and obesity or overweight.
Trial status: Active, not recruiting
Clinical Trials Identifier: NCT06914895
Trial Name: A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight (SURPASS-T1D-1)
Diabetes Type: Type 1 diabetes
Trial Sponsor: Eli Lilly
Why is this study important?
GLP-1 medications have traditionally been off-limits for people with type 1 diabetes due to concerns around risks like hypoglycemia and diabetic ketoacidosis (DKA). That may change with a new study – the first-of-its-kind – testing tirzepatide in people with type 1 diabetes and obesity or overweight.
Tirzepatide is a GLP-1/GIP therapy currently FDA-approved for weight management (Zepbound), type 2 diabetes (Mounjaro), and sleep apnea. Research indicates the same benefits drugs like tirzepatide have for type 2 diabetes – improved blood sugar levels, increased time in range, and proven benefits for both the heart and kidneys – would likely extend to people with type 1.
This study represents a first step towards a monumental win for the type 1 community. If successful, tirzepatide could become the first GLP-1/GIP therapy approved for type 1 diabetes.
How does the trial work?
Participants will be randomly assigned to one of four tirzepatide dosing groups or the placebo group. Those assigned to a treatment group will receive a once-weekly subcutaneous injection of tirzepatide while the other group will receive a weekly placebo injection. The study will last about 49 weeks and may include up to 23 visits.
To determine the safety and effectiveness of tirzepatide, researchers will measure changes in A1C, time in range, body weight, blood pressure, and cholesterol.
Are you interested in participating?
You may be eligible to participate if you are 18 years or older and have:
- Type 1 diabetes and have been on insulin for at least one year prior to screening
- An A1C of 7% to 10.5% at screening
- A body mass index of 25 or higher at screening
- Stable weight for at least 90 days prior to screening and agree not to start an intensive diet or exercise program during the study
People who have had two or more hospitalizations for hyperglycemia or DKA in the past six months, have had one or more emergency treatments for severe hypoglycemia in the past three months, or are receiving treatment for diabetic retinopathy or macular edema are not eligible to participate in this study. See a full list of inclusion/exclusion criteria here.
This trial is currently recruiting in multiple locations worldwide. To enroll or learn more about this study, contact clinical_inquiry_hub@lilly.com or call 1-877-285-4559.
Learn more about GLP-1 medications for people with type 1 diabetes here: