RECRUITING

A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide

Talk to us

Conditions

Type 2 DiabetesObesityOverweight

Quick Navigation

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 purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.

Official Title

A Parallel-Group Treatment, Phase 2, Double-Blind Study of Once-Weekly Subcutaneous LY3457263 Compared to Placebo in Participants With Type 2 Diabetes Mellitus on a Stable Dose of Semaglutide or Tirzepatide Who Failed to Achieve HbA1c Goal

Quick Facts

Study Start:2025-03-28
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06897475

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 type 2 diabetes
  2. * Have HbA1c ≥7.5% to ≤10.5% at screening
  3. * Have a body mass index (BMI) of ≥27 kilograms per square meter (kg/m2) at screening
  4. * Have had a stable body weight for the three months prior to screening
  5. * On stable treatment dose of one of the following incretins for at least three months:
  6. * Injectable semaglutide (1 and 2 milligram (mg))
  7. * Injectable tirzepatide (5, 7.5, 10, 12.5 and 15 mg)
  1. * Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar coma
  2. * Have a prior or planned surgical treatment for obesity
  3. * Have any of the following cardiovascular conditions within three months prior to screening:
  4. * acute myocardial infarction
  5. * cerebrovascular accident (stroke)
  6. * unstable angina, or
  7. * hospitalization due to congestive heart failure
  8. * Have used insulin to control blood glucose within the past year (short-term use allowed)
  9. * Current use of another oral antihyperglycemic medication (OAM) (including but not limited to, Dipeptidyl Peptidase IV Inhibitors (DPP-4i) and meglitinides) may be randomized if the additional OAM treatment was discontinued at least 3 months prior to screening
  10. * If participant has been on stable doses (for at least three months) of up to three OAMs (limited to metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, alpha-glucosidase inhibitors, sulfonylurea, and/or thiazolidinediones (TZD), they are permitted to participate in the study
  11. * Have taken any medications or alternative remedies for weight loss within three months 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
1-317-615-4559
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)

Helios Clinical Research - Phoenix
Phoenix, Arizona, 85028
United States
Wolverine Clinical Trials
Tustin, California, 92780
United States
Renstar Medical Research
Ocala, Florida, 34471
United States
Oviedo Medical Research
Oviedo, Florida, 32765
United States
Balanced Life Health Care Solutions/SKYCRNG
Lawrenceville, Georgia, 30046
United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
United States
Elite Clinical Trials
Rexburg, Idaho, 83440
United States
Investigators Research Group
Brownsburg, Indiana, 46112
United States
Richmond University Medical Center
Staten Island, New York, 10310
United States
Southgate Medical Group
West Seneca, New York, 14224
United States
Lucas Research, Inc.
Morehead City, North Carolina, 28557
United States
Shelby Clinical Research
Shelby, North Carolina, 28150
United States
Providence Health Partners-Center for Clinical Research
Dayton, Ohio, 45439
United States
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069
United States
Juno Research
Houston, Texas, 77040
United States
Southern Endocrinology Associates
Mesquite, Texas, 75149
United States
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, 78681
United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
United States
Texas Valley Clinical Research
Weslaco, Texas, 78596
United States
Eastside Research Associates
Redmond, Washington, 98052
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 Date2025-03-28
Study Completion Date2027-01

Study Record Updates

Study Start Date2025-03-28
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

  • Obesity
  • Overweight

Additional Relevant MeSH Terms

  • Type 2 Diabetes