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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

RECRUITINGPhase 2Sponsored by Eli Lilly and Company
Actively Recruiting
PhasePhase 2
SponsorEli Lilly and Company
Started2025-03-28
Est. completion2026-12
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
Locations20 sites

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 stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
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

Conditions2

DiabetesType 2 Diabetes

Locations20 sites

Helios Clinical Research - Phoenix
Phoenix, Arizona, 85028
480-372-5996
Wolverine Clinical Trials
Santa Ana, California, 92706
714-617-2426
Renstar Medical Research
Ocala, Florida, 34471
352-629-5800
Oviedo Medical Research
Oviedo, Florida, 32765
407-977-2705
Balanced Life Health Care Solutions/SKYCRNG
Lawrenceville, Georgia, 30046
770-696-4541

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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