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

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

Recruiting
18-75 years
All
Phase 2

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Overview

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.

Eligibility

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study details
    Type 2 Diabetes

NCT06897475

Eli Lilly and Company

15 October 2025

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FAQs

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