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 Sex
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 5352963, California 5332921 93111
Contact:
805-682-7638

Care Access - Santa Clarita
Santa Clarita 5393049, California 5332921 91321
Contact:
661-371-7272

University of Colorado Anschutz Medical Campus
Aurora 5412347, Colorado 5417618 80045
Contact:
303-724-6713

Atlanta Diabetes Associates
Atlanta 4180439, Georgia 4197000 30318

Orita Clinical Research
Decatur 4191124, Georgia 4197000 30034

North Georgia Clinical Research
Woodstock 4231874, Georgia 4197000 30189
Contact:
678-494-5735

East-West Medical Research Institute
Honolulu 5856195, Hawaii 5855797 96814
Contact:
808-531-6886

Rocky Mountain Clinical Research
Idaho Falls 5596475, Idaho 5596512 83404
Contact:
208-522-6005

Southern Illinois University School of Medicine
Springfield 4250542, Illinois 4896861 62702
Contact:
217-545-0176

Indiana University Health University Hospital
Indianapolis 4259418, Indiana 4921868 46202
Contact:
317-278-6017

Iowa Diabetes and Endocrinology Research Center
West Des Moines 4881346, Iowa 4862182 50266

Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital
Covington 4288809, Kentucky 6254925 41011

Endocrine and Metabolic Consultants
Rockville 4367175, Maryland 4361885 20852
Contact:
301-770-7373

HealthPartners Institute dba International Diabetes Center
Minneapolis 5037649, Minnesota 5037779 55416
Contact:
952-993-1913

SKY Integrative Medical Center/SKYCRNG
Ridgeland 4443296, Mississippi 4436296 39157
Contact:
601-567-1321

Boeson Research MSO
Missoula 5666639, Montana 5667009 59804
Contact:
406-763-8833

Palm Research Center Tenaya
Las Vegas 5506956, Nevada 5509151 89128
Contact:
702-736-5161

Palm Research Center Sunset
Las Vegas 5506956, Nevada 5509151 89148
Contact:
702-736-5161

Albany Medical College, Division of Community Endocrinology
Albany 5106834, New York 5128638 12203
Contact:
518-264-4420

Research Foundation of SUNY - University of Buffalo
Buffalo 5110629, New York 5128638 14221
Contact:
716-535-1850

NYC Research
New York 5128581, New York 5128638 10016
Contact:
516-574-9232

SUNY Upstate Medical University
Syracuse 5140405, New York 5128638 13210
Contact:
315-464-9006

Lucas Research, Inc.
Morehead City 4480153, North Carolina 4482348 28557
Contact:
252-222-5700

Care Access - Lima
Lima 5160783, Ohio 5165418 45805

Alliance for Multispecialty Research, LLC
Norman 4543762, Oklahoma 4544379 73069
Contact:
405-701-8999

Suburban Research Associates
West Chester 4562144, Pennsylvania 6254927 19380

Texas Diabetes & Endocrinology, P.A.
Austin 4671654, Texas 4736286 78731
Contact:
512-334-3505

Velocity Clinical Research, Dallas
Dallas 4684888, Texas 4736286 75230
Contact:
682-348-1169

Tekton Research, LLC.
McKinney 4710178, Texas 4736286 75069
Contact:
972-777-6011

Medrasa Clinical Research
Wylie 4743275, Texas 4736286 75098
Contact:
469-449-3645

Eastside Research Associates
Redmond 5808079, Washington 5815135 98052
Contact:
425-869-6828

Rainier Clinical Research Center
Renton 5808189, Washington 5815135 98057
Contact:
425-251-1720

Advanced Clinical Research, LLC
Bayamón 4562831, Puerto Rico 00959
Contact:
7872696590

Manati Center for Clinical Research
Manatí 4566137, Puerto Rico 00674
Contact:
787-903-1974

More Details

NCT ID
NCT06914895
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@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