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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT06897475

Run by

Eli Lilly and Company

People needed

240

Starts

2025-03-28

Expected to finish

2027-01-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Wolverine Clinical Trials — Santa Ana, California, United States (enrolling)
• Renstar Medical Research — Ocala, Florida, United States (enrolling)
• Oviedo Medical Research — Oviedo, Florida, United States (enrolling)
• Balanced Life Health Care Solutions/SKYCRNG — Lawrenceville, Georgia, United States (enrolling)
• Physicians Research Associates — Lawrenceville, Georgia, United States (enrolling)
• Rophe Adult and Pediatric Medicine/SKYCRNG — Union City, Georgia, United States (enrolling)
• North Georgia Clinical Research — Woodstock, Georgia, United States (enrolling)
• Elite Clinical Trials — Rexburg, Idaho, United States (enrolling)
• Investigators Research Group — Brownsburg, Indiana, United States (enrolling)
• Clinical Research of Philadelphia — Pennington, New Jersey, United States (enrolling)
• NYC Research INC — Long Island City, New York, United States (enrolling)
• Richmond University Medical Center — Staten Island, New York, United States (enrolling)
• Southgate Medical Group — West Seneca, New York, United States (enrolling)
• Lucas Research, Inc. — Morehead City, North Carolina, United States (enrolling)
• Shelby Clinical Research — Shelby, North Carolina, United States (enrolling)
• Providence Health Partners-Center for Clinical Research — Dayton, Ohio, United States (enrolling)
• Alliance for Multispecialty Research, LLC — Norman, Oklahoma, United States (enrolling)
• Frontier Clinical Research, LLC — Scottdale, Pennsylvania, United States (enrolling)
• Juno Research — Houston, Texas, United States (enrolling)
• Southern Endocrinology Associates — Mesquite, Texas, United States (enrolling)
• Texas Diabetes & Endocrinology, P.A. — Round Rock, Texas, United States (enrolling)
• Consano Clinical Research, LLC — Shavano Park, Texas, United States (enrolling)
• Texas Valley Clinical Research — Weslaco, Texas, United States (enrolling)
• Eastside Research Associates — Redmond, Washington, United States (enrolling)
• Helios Clinical Research - Phoenix — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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