A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tirzepatide Dose 1 		Participants will receive tirzepatide subcutaneously (SC)
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Experimental
Tirzepatide Dose 2 		Participants will receive tirzepatide SC
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Experimental
Tirzepatide Dose 3 		Participants will receive tirzepatide SC
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Experimental
Tirzepatide Dose 4 		Participants will receive tirzepatide SC
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Placebo Comparator
Placebo 		Participants will receive placebo SC
  • Drug: Placebo
    Administered SC

Recruiting Locations

Sansum Diabetes Research Institute
Goleta, California 93111
Contact:
805-682-7638

Care Access - Santa Clarita
Santa Clarita, California 91321
Contact:
661-371-7272

Atlanta Diabetes Associates
Atlanta, Georgia 30318

Orita Clinical Research
Decatur, Georgia 30034

North Georgia Clinical Research
Woodstock, Georgia 30189
Contact:
678-494-5735

East-West Medical Research Institute
Honolulu, Hawaii 96814
Contact:
808-531-6886

Rocky Mountain Clinical Research
Idaho Falls, Idaho 83404
Contact:
208-522-6005

Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa 50266

Endocrine and Metabolic Consultants
Rockville, Maryland 20852
Contact:
301-770-7373

SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi 39157
Contact:
601-567-1321

Boeson Research MSO
Missoula, Montana 59804
Contact:
406-763-8833

Palm Research Center Tenaya
Las Vegas, Nevada 89128
Contact:
702-736-5161

Palm Research Center Sunset
Las Vegas, Nevada 89148
Contact:
702-736-5161

Research Foundation of SUNY - University of Buffalo
Buffalo, New York 14221
Contact:
716-535-1850

NYC Research
New York, New York 10016
Contact:
516-574-9232

SUNY Upstate Medical University
Syracuse, New York 13210
Contact:
315-464-9006

Lucas Research, Inc.
Morehead City, North Carolina 28557
Contact:
252-222-5700

Care Access - Lima
Lima, Ohio 45805

Alliance for Multispecialty Research, LLC
Norman, Oklahoma 73069
Contact:
405-701-8999

Suburban Research Associates
West Chester, Pennsylvania 19380

Texas Diabetes & Endocrinology, P.A.
Austin, Texas 78731
Contact:
512-334-3505

Velocity Clinical Research, Dallas
Dallas, Texas 75230
Contact:
682-348-1169

Tekton Research, LLC.
McKinney, Texas 75069
Contact:
972-777-6011

Medrasa Clinical Research
Wylie, Texas 75098
Contact:
469-449-3645

Eastside Research Associates
Redmond, Washington 98052
Contact:
425-869-6828

Rainier Clinical Research Center
Renton, Washington 98057
Contact:
425-251-1720

Advanced Clinical Research, LLC
Bayamón, Puerto Rico 00959
Contact:
7872696590

Manati Center for Clinical Research
Manati, Puerto Rico 00674
Contact:
787-903-1974

More Details

NCT ID
NCT06914895
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
317-615-4559
clinical_inquiry_hub@lilly.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center