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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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)

🚫 You may not be able to join if…

• 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

Where this trial is running

• Helios Clinical Research - Phoenix, Phoenix, Arizona, United States
• Wolverine Clinical Trials, Santa Ana, California, United States
• Renstar Medical Research, Ocala, Florida, United States
• Oviedo Medical Research, Oviedo, Florida, United States
• Balanced Life Health Care Solutions/SKYCRNG, Lawrenceville, Georgia, United States
• Physicians Research Associates, Lawrenceville, Georgia, United States
• Rophe Adult and Pediatric Medicine/SKYCRNG, Union City, Georgia, United States
• North Georgia Clinical Research, Woodstock, Georgia, United States
• Elite Clinical Trials, Rexburg, Idaho, United States
• Investigators Research Group, Brownsburg, Indiana, United States
• Clinical Research of Philadelphia, Pennington, New Jersey, United States
• NYC Research INC, Long Island City, New York, United States

+ 48 more sites.

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06897475.