ACTIVE_NOT_RECRUITING

A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes

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Conditions

ObesityOverweightType 2 Diabetes

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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, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate the safety and efficacy of LY3841136 for chronic weight management alone or in combination with Tirzepatide across a wide dose range in participants with Type 2 Diabetes. Participation in the study will last about 64 weeks.

Official Title

A Phase 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Management With LY3841136 and Tirzepatide, Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes

Quick Facts

Study Start:2024-09-20
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06603571

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. * Have a Body Mass Index (BMI) of ≥27 kilograms per square meter (kg/m²)
  2. * Have Type 2 Diabetes
  3. * Have a HbA1c ≥7.0 % (53 millimoles/mole (mmol/mol)) to ≤10.5% (91 mmol/mol) and treated with diet and exercise alone or with a stable dose of metformin (and not more than the locally approved dose) with or without a sodium-glucose cotransporter 2 (SGLT2) inhibitor for at least 3 months prior to screening
  4. * Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss)
  1. * Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
  2. * Have an on-going or history of bradyarrhythmia and/or sinus bradycardia
  3. * Have an elevated resting pulse rate (mean \>100 beats per minute (bpm)) or reduced resting pulse rate (mean \<60 bpm) at screening
  4. * Have any of the following cardiovascular conditions within 6 months prior to screening:
  5. * acute myocardial infarction
  6. * cerebrovascular accident (stroke)
  7. * unstable angina, or
  8. * hospitalization due to congestive heart failure
  9. * Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<45 milliliters per minute (mL/min)/1.73 m2
  10. * Have a history of acute or chronic pancreatitis
  11. * Have fasting triglycerides \>500 milligrams per deciliter (mg/dL) (5.7 mmol/L) at screening
  12. * All concomitant medications should be at a stable dose for at least 3 months prior to screening
  13. * Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening.
  14. * Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
  15. * Have poorly controlled hypertension.
  16. * Have a history of symptomatic gallbladder disease within the past 2 years
  17. * Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
  18. * Have a lifetime history of suicide attempts.

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)

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, 85225
United States
HOPE Research Institute
Phoenix, Arizona, 85032
United States
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260
United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson, Arizona, 85712
United States
NorCal Medical Research, Inc
Greenbrae, California, 94904
United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255
United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274
United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905
United States
Northeast Research Institute (NERI)
Fleming Island, Florida, 32003
United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012
United States
New Horizon Research Center
Miami, Florida, 33165
United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
United States
Charter Research - Winter Park
Orlando, Florida, 32803
United States
Charter Research - Lady Lake
The Villages, Florida, 32162
United States
Medical Research Partners
Ammon, Idaho, 83406
United States
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, 60640
United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640
United States
NorthShore University Health System
Skokie, Illinois, 60077
United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266
United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606
United States
Knownwell
Needham, Massachusetts, 02492
United States
Lucida Clinical Trials
New Bedford, Massachusetts, 02740
United States
Headlands Research - Detroit
Southfield, Michigan, 48034
United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098
United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303
United States
Clinvest Headlands Llc
Springfield, Missouri, 65807
United States
Las Vegas Medical Research
Las Vegas, Nevada, 89128
United States
Dent Neurologic Institute
Amherst, New York, 14226
United States
Velocity Clinical Research, Syracuse
East Syracuse, New York, 13057
United States
North Suffolk Neurology
Port Jefferson Station, New York, 11776
United States
Rochester Clinical Research, LLC
Rochester, New York, 14609
United States
Medication Management
Greensboro, North Carolina, 27405
United States
Monroe Biomedical Research
Monroe, North Carolina, 28112
United States
Lucas Research, Inc
Morehead City, North Carolina, 28557
United States
Lucas Research, Inc.
New Bern, North Carolina, 28562
United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212
United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607
United States
Quality Medical Research
Nashville, Tennessee, 37211
United States
IMA Clinical Research Austin
Austin, Texas, 78745
United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
United States
FutureSearch Trials of Dallas
Dallas, Texas, 75251
United States
PlanIt Research, PLLC
Houston, Texas, 77079
United States
Tekton Research - Fredericksburg Road
San Antonio, Texas, 78229
United States
Endeavor Clinical Trials
San Antonio, Texas, 78240
United States
Texas Valley Clinical Research
Weslaco, Texas, 78596
United States
Spectrum Medical, Inc.
Danville, Virginia, 24541
United States
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, 98801
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 Date2024-09-20
Study Completion Date2026-08

Study Record Updates

Study Start Date2024-09-20
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

  • Type 2 Diabetes

Additional Relevant MeSH Terms

  • Obesity
  • Overweight