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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Type 1 Diabetes
Intervention / Treatment

-

Contacts and Locations

Goleta

Sansum Diabetes Research Institute, Goleta, California, United States, 93111

Santa Clarita

Care Access - Santa Clarita, Santa Clarita, California, United States, 91321

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Atlanta

Atlanta Diabetes Associates, Atlanta, Georgia, United States, 30318

Decatur

Orita Clinical Research, Decatur, Georgia, United States, 30034

Woodstock

North Georgia Clinical Research, Woodstock, Georgia, United States, 30189

Honolulu

East-West Medical Research Institute, Honolulu, Hawaii, United States, 96814

Idaho Falls

Rocky Mountain Clinical Research, Idaho Falls, Idaho, United States, 83404

Springfield

Southern Illinois University School of Medicine, Springfield, Illinois, United States, 62702

Indianapolis

Indiana University Health University Hospital, Indianapolis, Indiana, United States, 46202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2027-05