A Long-Term Study of Tirzepatide (LY3298176) 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 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

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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 long-term in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 20 months.

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Long-Term Safety of Tirzepatide Once Weekly Compared to Placebo in Adults With Type 1 Diabetes and Obesity or Overweight

A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight

Condition
Type 1 Diabetes
Intervention / Treatment

-

Contacts and Locations

Bonita

Kaiser Permanente Bonita Medical Offices, Bonita, California, United States, 91902

Escondido

AMCR Institute, Escondido, California, United States, 92025

Newport Beach

Mary & Dick Allen Diabetes Center, Newport Beach, California, United States, 92663

Tustin

University Clinical Investigators, Inc., Tustin, California, United States, 92780

Aurora

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

West Palm Beach

Metabolic Research Institute, Inc., West Palm Beach, Florida, United States, 33401

West Des Moines

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

Minneapolis

HealthPartners Institute dba International Diabetes Center, Minneapolis, Minnesota, United States, 55416

Chesterfield

Clinical Research Professionals, Chesterfield, Missouri, United States, 63005

Springfield

Clinvest Headlands Llc, Springfield, Missouri, United States, 65807

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

2027-12