Tirzepatide for adults with type 1 diabetes and obesity

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Tirzepatide Once Weekly Compared to Placebo in Adult Participants With Type 1 Diabetes and Obesity or Overweight

Phase 3 Interventional Eli Lilly and Company · NCT06914895

This study is testing if a new medication called tirzepatide can help adults with type 1 diabetes who are overweight or obese manage their blood sugar and lose weight.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment905 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations148 sites (Goleta, California and 147 other locations)
Trial IDNCT06914895 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of tirzepatide in adults diagnosed with type 1 diabetes who are also classified as overweight or obese. Participants will receive either tirzepatide or a placebo over a period of approximately 49 weeks. The study aims to assess changes in blood sugar control and weight management among the participants. Inclusion criteria require stable insulin treatment and specific HbA1c and BMI levels, while certain health conditions will exclude others from participation.

Who should consider this trial

Good fit: Ideal candidates are adults with type 1 diabetes on insulin therapy who have a BMI of 25 or higher and stable weight.

Not a fit: Patients with a history of severe hypoglycemia or those currently receiving treatment for diabetic retinopathy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve blood sugar control and aid in weight management for patients with type 1 diabetes and obesity.

How similar studies have performed: Previous studies have shown promising results with tirzepatide in other populations, indicating potential for success in this specific group.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Have type 1 diabetes and on insulin treatment for at least one year prior to screening
* Have an HbA1c value of 7.0% to 10.5% inclusive, at screening
* Have a body mass index (BMI) of ≥25 kilograms per square meter (kg/m2) at screening
* Are of stable weight for at least 90 days prior to screening and agree to not start an intensive diet or exercise program during the study

Exclusion Criteria:

* Have experienced two or more events requiring hospitalization due to poor glucose control (hyperglycemia or (diabetic ketoacidosis (DKA)) during the period of 180 days prior to screening and until randomization.
* Have experienced one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization.
* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
* Have had chronic or acute pancreatitis
* Have used any weight loss drugs or alternative remedies, including herbal or nutritional supplements, within 90 days prior to screening

Where this trial is running

Goleta, California and 147 other locations

+98 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Type 1 DiabetesObesityOverweight
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.