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
SexALL
Conditions studied
Type 2 Diabetes
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.