ACTIVE_NOT_RECRUITING

A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity

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Conditions

Type 2 DiabetesObesityDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseaseEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightTirzepatideIncretins

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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 learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.

Official Title

A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Investigational Tirzepatide Doses in Participants With Type 2 Diabetes and Obesity

Quick Facts

Study Start:2023-09-21
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06037252

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 to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
  2. * Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months prior to screening.
  3. * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
  4. * Have a prior or planned surgical treatment for obesity.
  5. * Use products intended for weight loss including prescription drugs, over the counter (OTC) drugs, and herbal preparations, within 3 months prior to screening.
  6. * Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<45 milliliter/min (mL/min)/1.73 m².
  7. * Have any of the following cardiovascular (CV) conditions within 2 months prior to screening.
  8. * acute myocardial infarction.
  9. * cerebrovascular accident (stroke).
  10. * unstable angina .
  11. * hospitalization due to congestive heart failure, or
  12. * coronary artery revascularization.
  13. * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2.
  14. * Have a history of chronic or acute pancreatitis.

Contacts and Locations

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)

Medical Advancement Centers of Arizona
Phoenix, Arizona, 85044
United States
John Muir Physician Network Research Center
Concord, California, 94520
United States
Care Access - Sacramento
Sacramento, California, 95831
United States
Care Access - Aurora
Aurora, Colorado, 80012
United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
United States
Retreat Medical Research
Miami, Florida, 33135
United States
American Research Centers of Florida
Pembroke Pines, Florida, 33027
United States
Alta Pharmaceutical Research Center
Norcross, Georgia, 30092
United States
AGILE Clinical Research Trials, LLC
Sandy Springs, Georgia, 30328
United States
Northwestern University
Chicago, Illinois, 60611
United States
Qualmedica Research, LLC
Evansville, Indiana, 47715
United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, 50265
United States
Accellacare - Wilmington - 1917 Tradd Court
Wilmington, North Carolina, 28401
United States
Velocity Clinical Research, Mt. Auburn
Cincinnati, Ohio, 45219
United States
Summit Headlands
Portland, Oregon, 97210
United States
Clinical Research Associates Inc
Nashville, Tennessee, 37203
United States
Juno Research
Houston, Texas, 77040
United States
Southern Endocrinology Associates
Mesquite, Texas, 75149
United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911
United States
Northwest Clinical Research Center
Bellevue, Washington, 98007
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 Date2023-09-21
Study Completion Date2026-10

Study Record Updates

Study Start Date2023-09-21
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • Diabetes Mellitus
  • Glucose Metabolism Disorders
  • Metabolic Disease
  • Endocrine System Diseases
  • Overnutrition
  • Nutrition Disorders
  • Body Weight
  • Tirzepatide
  • Incretins

Additional Relevant MeSH Terms

  • Type 2 Diabetes
  • Obesity