Recruiting
A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide
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.
ClinicalTrials.gov IDNCT06897475
PhasePHASE2
Enrollment200
SponsorEli Lilly and Company
Age18 Years and older
SexALL
About this study
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.
Interventions
- Drug: LY3457263 — Administered SC
- Drug: Placebo — Administered SC
Primary outcomes
- Change from Baseline in Hemoglobin A1c (HbA1c) (Baseline, Week 24)
Eligibility information
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 locations
- Helios Clinical Research - Phoenix, Phoenix, Arizona 85028 United States
- Wolverine Clinical Trials, Santa Ana, California 92706 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
- Physicians Research Associates, Lawrenceville, Georgia 30046 United States
- Rophe Adult and Pediatric Medicine/SKYCRNG, Union City, Georgia 30291 United States
- North Georgia Clinical Research, Woodstock, Georgia 30189 United States
- Elite Clinical Trials, Rexburg, Idaho 83440 United States
- Investigators Research Group, Brownsburg, Indiana 46112 United States
Showing 10 of 60 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.