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Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting
Phase 3

Tirzepatide

Sponsor:

Eli Lilly and Company

Code:

NCT06914895

Conditions

Type 1 Diabetes

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Placebo

Study Details

Brief summary:

The main purpose of this study is to find out how well and how safely tirzepatide works in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 49 weeks.

Conditions

Type 1 Diabetes

Obesity

Overweight

Study ID

NCT06914895

Start date

Apr 25, 2025

Status verified date

Jan, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

905 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tirzepatide Dose 1

Participants will receive tirzepatide subcutaneously (SC)

experimental: Tirzepatide Dose 2

Participants will receive tirzepatide SC

experimental: Tirzepatide Dose 3

Participants will receive tirzepatide SC

experimental: Tirzepatide Dose 4

Participants will receive tirzepatide SC

placebo comparator: Placebo

Participants will receive placebo SC

Interventions

Tirzepatide

Administered SC

Placebo

Administered SC

Primary outcome measure

  • Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 40 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Care Access - Santa Clarita

Recruiting

Santa Clarita, California, United States, 91321

Contacts

661-371-7272

Principal Investigator:

Sina Tebi

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

303-724-6713

Principal Investigator:

Satish Garg

Atlanta Diabetes Associates

Recruiting

Atlanta, Georgia, United States, 30318

Principal Investigator:

Bruce Bode

Orita Clinical Research

Recruiting

Decatur, Georgia, United States, 30034

Principal Investigator:

Ahmad Jingo

North Georgia Clinical Research

Recruiting

Woodstock, Georgia, United States, 30189

Contacts

678-494-5735

Principal Investigator:

Bram Wieskopf

East-West Medical Research Institute

Recruiting

Honolulu, Hawaii, United States, 96814

Contacts

808-531-6886

Principal Investigator:

Cindy Pau

Rocky Mountain Clinical Research

Recruiting

Idaho Falls, Idaho, United States, 83404

Contacts

208-522-6005

Principal Investigator:

Kevin Prier

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

217-545-0176

Principal Investigator:

Gabriel Uwaifo

Indiana University Health University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

317-278-6017

Principal Investigator:

Viral Shah

Iowa Diabetes and Endocrinology Research Center

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

515-329-6800

Principal Investigator:

Robert Burr

Endocrine and Metabolic Consultants

Recruiting

Rockville, Maryland, United States, 20852

Contacts

301-770-7373

Principal Investigator:

Helena Rodbard

HealthPartners Institute dba International Diabetes Center

Recruiting

Minneapolis, Minnesota, United States, 55416

Contacts

952-993-1913

Principal Investigator:

Richard Bergenstal

SKY Integrative Medical Center/SKYCRNG

Recruiting

Ridgeland, Mississippi, United States, 39157

Contacts

601-567-1321

Principal Investigator:

Bob Hutchins

Boeson Research MSO

Recruiting

Missoula, Montana, United States, 59804

Contacts

406-763-8833

Principal Investigator:

Aubrey Remmers

Palm Research Center Tenaya

Recruiting

Las Vegas, Nevada, United States, 89128

Contacts

702-736-5161

Principal Investigator:

Samer Nakhle

Palm Research Center Sunset

Recruiting

Las Vegas, Nevada, United States, 89148

Contacts

702-736-5161

Principal Investigator:

Betsy Palal

Albany Medical College, Division of Community Endocrinology

Recruiting

Albany, New York, United States, 12203

Contacts

518-264-4420

Principal Investigator:

Robert Busch

Research Foundation of SUNY - University of Buffalo

Recruiting

Buffalo, New York, United States, 14221

Contacts

716-535-1850

Principal Investigator:

Ajay Chaudhuri

NYC Research

Recruiting

New York, New York, United States, 10016

Contacts

516-574-9232

Principal Investigator:

Anastasios Manessis

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

315-464-9006

Principal Investigator:

Malek El Muayed

Lucas Research, Inc.

Recruiting

Morehead City, North Carolina, United States, 28557

Contacts

252-222-5700

Principal Investigator:

Kathryn Lucas

Care Access - Lima

Recruiting

Lima, Ohio, United States, 45805

Principal Investigator:

Jimmy Alele

Alliance for Multispecialty Research, LLC

Recruiting

Norman, Oklahoma, United States, 73069

Contacts

405-701-8999

Principal Investigator:

Lisa Connery

Suburban Research Associates

Recruiting

West Chester, Pennsylvania, United States, 19380

Principal Investigator:

Omer Abdullah

Texas Diabetes & Endocrinology, P.A.

Recruiting

Austin, Texas, United States, 78731

Contacts

512-334-3505

Principal Investigator:

Thomas Blevins

Velocity Clinical Research, Dallas

Recruiting

Dallas, Texas, United States, 75230

Contacts

682-348-1169

Principal Investigator:

Julio Rosenstock

Tekton Research, LLC.

Recruiting

McKinney, Texas, United States, 75069

Contacts

972-777-6011

Principal Investigator:

Pablo Mora

Medrasa Clinical Research

Recruiting

Wylie, Texas, United States, 75098

Contacts

469-449-3645

Principal Investigator:

Tanvir Ahmad

Eastside Research Associates

Recruiting

Redmond, Washington, United States, 98052

Contacts

425-869-6828

Principal Investigator:

Christopher Price

Rainier Clinical Research Center

Recruiting

Renton, Washington, United States, 98057

Contacts

425-251-1720

Principal Investigator:

Frances Broyles

More Information

Sponsor

Eli Lilly and Company

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-01-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.