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A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight

RECRUITINGPhase 3Sponsored by Eli Lilly and Company
Actively Recruiting
PhasePhase 3
SponsorEli Lilly and Company
Started2025-05-12
Est. completion2027-04
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations18 sites

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 about 20 months.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

ObesityOverweightType 1 Diabetes

Locations18 sites

Kaiser Permanente Bonita Medical Offices
Bonita, California, 91902
877-236-0333
AMCR Institute
Escondido, California, 92025
760-466-1520
Mary & Dick Allen Diabetes Center
Newport Beach, California, 92663
David Ahn
University Clinical Investigators, Inc.
Tustin, California, 92780
714-734-7944
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
303-724-6713

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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