A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Type 1 Diabetes, Obesity, Overweight
In brief
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.
Key facts
- Study ID
- NCT06962280
- Run by
- Eli Lilly and Company
- People needed
- 465
- Starts
- 2025-05-12
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-02-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- AMCR Institute — Escondido, California, United States
- Mary & Dick Allen Diabetes Center — Newport Beach, California, United States
- University Clinical Investigators, Inc. — Tustin, California, United States
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
- Metabolic Research Institute, Inc. — West Palm Beach, Florida, United States
- Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
- HealthPartners Institute dba International Diabetes Center — Minneapolis, Minnesota, United States
- Clinical Research Professionals — Chesterfield, Missouri, United States
- Clinvest Headlands Llc — Springfield, Missouri, United States
- Las Vegas Endocrinology — Henderson, Nevada, United States
- University of North Carolina Medical Center — Chapel Hill, North Carolina, United States
- Velocity Clinical Research, Dallas — Dallas, Texas, United States
- Juno Research — Houston, Texas, United States
- Southern Endocrinology Associates — Mesquite, Texas, United States
- Texas Diabetes & Endocrinology, P.A. — Round Rock, Texas, United States
- San Antonio Clinical Trials — San Antonio, Texas, United States
- Texas Valley Clinical Research — Weslaco, Texas, United States
- Buenos Aires Macula S.A — Buenos Aires, Argentina
- Stat Research S.A. — Buenos Aires, Argentina
- Mautalen Salud e Investigación — Buenos Aires, Argentina
- Centro Diabetológico Dr. Waitman — Córdoba, Argentina
- CIPADI - Centro Integral de Prevencion y Atencion en Diabetes — Godoy Cruz, Argentina
- Centro de Investigaciones Clínicas Baigorria — Granadero Baigorria, Argentina
- Instituto Médico Catamarca IMEC — Rosario, Argentina
- Kaiser Permanente Bonita Medical Offices — Bonita, California, United States
Full record on ClinicalTrials.gov
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