A Long-Term Study of Tirzepatide (LY3298176) 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 long-term in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 20 months.

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 		Participants will receive tirzepatide subcutaneously (SC)
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Placebo Comparator
Placebo 		Participants will receive placebo SC
  • Drug: Placebo
    Administered SC

Recruiting Locations

Kaiser Permanente Bonita Medical Offices
Bonita 5329954, California 5332921 91902
Contact:
877-236-0333

AMCR Institute
Escondido 5346827, California 5332921 92025
Contact:
760-466-1520

Mary & Dick Allen Diabetes Center
Newport Beach 5376890, California 5332921 92663

University Clinical Investigators, Inc.
Tustin 5404119, California 5332921 92780
Contact:
714-734-7944

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

Metabolic Research Institute, Inc.
West Palm Beach 4177887, Florida 4155751 33401
Contact:
561-802-3060

Iowa Diabetes and Endocrinology Research Center
West Des Moines 4881346, Iowa 4862182 50266
Contact:
515-329-6800

HealthPartners Institute dba International Diabetes Center
Minneapolis 5037649, Minnesota 5037779 55416

Clinical Research Professionals
Chesterfield 4381072, Missouri 4398678 63005
Contact:
636-220-1200

Clinvest Headlands Llc
Springfield 4409896, Missouri 4398678 65807
Contact:
417-883-7889

Las Vegas Endocrinology
Henderson 5505411, Nevada 5509151 89074
Contact:
702-605-5750

University of North Carolina Medical Center
Chapel Hill 4460162, North Carolina 4482348 27514
Contact:
984-974-3004

Velocity Clinical Research, Dallas
Dallas 4684888, Texas 4736286 75230

Juno Research
Houston 4699066, Texas 4736286 77040
Contact:
713-779-5494

Southern Endocrinology Associates
Mesquite 4710826, Texas 4736286 75149
Contact:
214-693-0904

Texas Diabetes & Endocrinology, P.A.
Round Rock 4724129, Texas 4736286 78681
Contact:
512-334-3505

San Antonio Clinical Trials
San Antonio 4726206, Texas 4736286 78240
Contact:
210-777-6854

Texas Valley Clinical Research
Weslaco 4740629, Texas 4736286 78596
Contact:
956-431-8090

More Details

NCT ID
NCT06962280
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