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Long-term effects of tirzepatide in adults with type 1 diabetes and obesity

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

Phase 3 Interventional Eli Lilly and Company · NCT06962280

This study is testing if tirzepatide can help adults with type 1 diabetes and obesity lose weight and manage their blood sugar better over 20 months.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment465 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations81 sites (Bonita, California and 80 other locations)
Trial IDNCT06962280 on ClinicalTrials.gov

What this trial studies

This study evaluates the long-term safety and efficacy 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 20 months. The study aims to assess changes in weight and glycemic control among participants while ensuring they maintain stable weight prior to the trial. Inclusion criteria focus on individuals who have been on insulin treatment for at least one year and meet specific HbA1c and BMI thresholds.

Who should consider this trial

Good fit: Ideal candidates are adults with type 1 diabetes who are overweight or obese and have been on insulin therapy for at least one year.

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 significantly improve weight management and glycemic control in adults with type 1 diabetes.

How similar studies have performed: Other studies have shown promising results with similar interventions, indicating potential for success in this approach.

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

Bonita, California and 80 other locations

+31 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.
View on ClinicalTrials.gov → Find more trials like this →
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.