RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-25
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06914895

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have type 1 diabetes and on insulin treatment for at least one year prior to screening
  2. * Have an HbA1c value of 7.0% to 10.5% inclusive, at screening
  3. * Have a body mass index (BMI) of ≥25 kilograms per square meter (kg/m2) at screening
  4. * 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
  1. * 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.
  2. * Have experienced one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization.
  3. * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
  4. * Have had chronic or acute pancreatitis
  5. * Have used any weight loss drugs or alternative remedies, including herbal or nutritional supplements, within 90 days prior to screening

Contacts and Locations

Study Contact

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

Principal Investigator

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 Locations (Sites)

Sansum Diabetes Research Institute
Goleta, California, 93111
United States
Care Access - Santa Clarita
Santa Clarita, California, 91321
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
United States
Orita Clinical Research
Decatur, Georgia, 30034
United States
North Georgia Clinical Research
Woodstock, Georgia, 30189
United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814
United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266
United States
Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital
Covington, Kentucky, 41011
United States
Endocrine and Metabolic Consultants
Rockville, Maryland, 20852
United States
HealthPartners Institute dba International Diabetes Center
Minneapolis, Minnesota, 55416
United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, 39157
United States
Boeson Research MSO
Missoula, Montana, 59804
United States
Palm Research Center Tenaya
Las Vegas, Nevada, 89128
United States
Palm Research Center Sunset
Las Vegas, Nevada, 89148
United States
Albany Medical College, Division of Community Endocrinology
Albany, New York, 12203
United States
Research Foundation of SUNY - University of Buffalo
Buffalo, New York, 14221
United States
NYC Research
New York, New York, 10016
United States
SUNY Upstate Medical University
Syracuse, New York, 13210
United States
Lucas Research, Inc.
Morehead City, North Carolina, 28557
United States
Care Access - Lima
Lima, Ohio, 45805
United States
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069
United States
Suburban Research Associates
West Chester, Pennsylvania, 19380
United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78731
United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
United States
Tekton Research, LLC.
McKinney, Texas, 75069
United States
Medrasa Clinical Research
Wylie, Texas, 75098
United States
Eastside Research Associates
Redmond, Washington, 98052
United States
Rainier Clinical Research Center
Renton, Washington, 98057
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-25
Study Completion Date2027-05

Study Record Updates

Study Start Date2025-04-25
Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

  • Type 1 Diabetes
  • Obesity
  • Overweight