Status:
RECRUITING
A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 sta...
Eligibility Criteria
Inclusion
- Have type 2 diabetes
- Have HbA1c ≥7.5% to ≤10.5% at screening
- Have a body mass index (BMI) of ≥27 kilograms per square meter (kg/m2) at screening
- Have had a stable body weight for the three months prior to screening
- On stable treatment dose of one of the following incretins for at least three months prior to screening:
- Injectable semaglutide (1 and 2 milligram (mg))
- Injectable tirzepatide (5, 7.5, 10, 12.5 and 15 mg)
Exclusion
- Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar coma
- Have a prior or planned surgical treatment for obesity
- Have any of the following cardiovascular conditions within three months prior to screening:
- acute myocardial infarction
- cerebrovascular accident (stroke)
- unstable angina, or
- hospitalization due to congestive heart failure
- Have used insulin to control blood glucose within the past year (short-term use allowed)
- Current use of prohibited oral antihyperglycemic medication (OAM) (including but not limited to, Dipeptidyl Peptidase IV Inhibitors (DPP-4i) and meglitinides) may be randomized if the prohibited OAM treatment was discontinued at least 3 months prior to screening
- If participant has been on stable doses (for at least three months) of up to three permitted 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
- Have taken any medications or alternative remedies for weight loss within three months prior to screening
Key Trial Info
Start Date :
March 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06897475
Start Date
March 28 2025
End Date
January 1 2027
Last Update
December 24 2025
Active Locations (56)
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