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
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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 905 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 148 sites (Goleta, California and 147 other locations) |
| Trial ID | NCT06914895 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
- Sansum Diabetes Research Institute — Goleta, California, United States (Not_yet_recruiting)
- Care Access - Santa Clarita — Santa Clarita, California, United States (Recruiting)
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Not_yet_recruiting)
- Atlanta Diabetes Associates — Atlanta, Georgia, United States (Recruiting)
- Orita Clinical Research — Decatur, Georgia, United States (Recruiting)
- North Georgia Clinical Research — Woodstock, Georgia, United States (Recruiting)
- East-West Medical Research Institute — Honolulu, Hawaii, United States (Recruiting)
- Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States (Recruiting)
- Southern Illinois University School of Medicine — Springfield, Illinois, United States (Not_yet_recruiting)
- Indiana University Health University Hospital — Indianapolis, Indiana, United States (Not_yet_recruiting)
- Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States (Recruiting)
- Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital — Covington, Kentucky, United States (Not_yet_recruiting)
- Endocrine and Metabolic Consultants — Rockville, Maryland, United States (Recruiting)
- HealthPartners Institute dba International Diabetes Center — Minneapolis, Minnesota, United States (Recruiting)
- SKY Integrative Medical Center/SKYCRNG — Ridgeland, Mississippi, United States (Recruiting)
- Boeson Research MSO — Missoula, Montana, United States (Recruiting)
- Palm Research Center Tenaya — Las Vegas, Nevada, United States (Recruiting)
- Palm Research Center Sunset — Las Vegas, Nevada, United States (Recruiting)
- Albany Medical College, Division of Community Endocrinology — Albany, New York, United States (Not_yet_recruiting)
- Research Foundation of SUNY - University of Buffalo — Buffalo, New York, United States (Recruiting)
- NYC Research — New York, New York, United States (Recruiting)
- SUNY Upstate Medical University — Syracuse, New York, United States (Not_yet_recruiting)
- Lucas Research, Inc. — Morehead City, North Carolina, United States (Recruiting)
- Care Access - Lima — Lima, Ohio, United States (Recruiting)
- Alliance for Multispecialty Research, LLC — Norman, Oklahoma, United States (Recruiting)
- Suburban Research Associates — West Chester, Pennsylvania, United States (Recruiting)
- Texas Diabetes & Endocrinology, P.A. — Austin, Texas, United States (Recruiting)
- Velocity Clinical Research, Dallas — Dallas, Texas, United States (Recruiting)
- Tekton Research, LLC. — McKinney, Texas, United States (Recruiting)
- Medrasa Clinical Research — Wylie, Texas, United States (Recruiting)
- Eastside Research Associates — Redmond, Washington, United States (Recruiting)
- Rainier Clinical Research Center — Renton, Washington, United States (Recruiting)
- Centro de Investigaciones Médicas Mar del Plata — Mar del Plata, Buenos Aires, Argentina (Not_yet_recruiting)
- Investigaciones Medicas Imoba Srl — Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina (Not_yet_recruiting)
- Ciprec — Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina (Not_yet_recruiting)
- Consultorio de Investigación Clínica EMO SRL — Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina (Not_yet_recruiting)
- Centro Medico Privado San Vicente Diabetes — Cordoba, Córdoba, Argentina (Not_yet_recruiting)
- Instituto Médico Río Cuarto — Río Cuarto, Córdoba, Argentina (Not_yet_recruiting)
- Centro de Salud e Investigaciones Médicas — Santa Rosa, La Pampa, Argentina (Not_yet_recruiting)
- Fundacion Estudios Clinicos — Rosario, Santa Fe, Argentina (Not_yet_recruiting)
- Centro de Investigaciones Metabólicas (CINME) — Ciudad Autónoma de Buenos Aires, Argentina (Not_yet_recruiting)
- Cenudiab — Ciudad Autónoma de Buenos Aires, Argentina (Not_yet_recruiting)
- Instituto de Investigaciones Clínicas Córdoba — Córdoba, Argentina (Not_yet_recruiting)
- Centro de Diagnóstico y Rehabilitación (CEDIR) — Santa Fe, Argentina (Not_yet_recruiting)
- Centro De Diabetes Metabolismo E Endocrinologia — Fortaleza, Ceará, Brazil (Not_yet_recruiting)
- Private Practice - Dr.Miguel N. Hissa — Fortaleza, Ceará, Brazil (Not_yet_recruiting)
- Cedoes — Vitória, Espírito Santo, Brazil (Not_yet_recruiting)
- Universidade Federal de Goias — Goiania, Goiás, Brazil (Not_yet_recruiting)
- Centro de Diabetes Curitiba — Curitiba, Paraná, Brazil (Not_yet_recruiting)
- Cpclin — Sao Paulo, São Paulo, Brazil (Not_yet_recruiting)
+98 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.