Status:
RECRUITING
A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 1 Diabetes
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main purpose of this study is to find out how well and how safely tirzepatide works long-term in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last abo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
465 Patients enrolled
Trial Details
Trial ID
NCT06962280
Start Date
May 12 2025
End Date
December 1 2027
Last Update
December 24 2025
Active Locations (79)
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1
Kaiser Permanente Bonita Medical Offices
Bonita, California, United States, 91902
2
AMCR Institute
Escondido, California, United States, 92025
3
Mary & Dick Allen Diabetes Center
Newport Beach, California, United States, 92663
4
University Clinical Investigators, Inc.
Tustin, California, United States, 92780