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RecruitingPhase 2

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

Eli Lilly and Company · NCT06897475

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
200
US sites recruiting
25
Study start
March 28, 2025
Record last updated
October 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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.

Being studied: LY3457263; Placebo

Conditions: Type 2 Diabetes

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Helios Clinical Research - Phoenix

    Phoenix, AZ 85028

    Site contact: 480-372-5996

  • Wolverine Clinical Trials

    Santa Ana, CA 92706

    Site contact: 714-617-2426

  • Renstar Medical Research

    Ocala, FL 34471

    Site contact: 352-629-5800

  • Oviedo Medical Research

    Oviedo, FL 32765

    Site contact: 407-977-2705

  • Balanced Life Health Care Solutions/SKYCRNG

    Lawrenceville, GA 30046

    Site contact: 770-696-4541

  • Physicians Research Associates

    Lawrenceville, GA 30046

    Site contact: 678-252-2375

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, GA 30291

    Site contact: 470-317-3604

  • North Georgia Clinical Research

    Woodstock, GA 30189

    Site contact: 678-494-5735

  • Elite Clinical Trials

    Rexburg, ID 83440

    Site contact: 208-356-8977

  • Investigators Research Group

    Brownsburg, IN 46112

    Site contact: 317-852-8280

  • Clinical Research of Philadelphia

    Pennington, NJ 08534

    Site contact: 215-676-6696

  • NYC Research INC

    Long Island City, NY 11106

    Site contact: 516-574-9232

  • Richmond University Medical Center

    Staten Island, NY 10310

    Site contact: Lina Leykina

  • Southgate Medical Group

    West Seneca, NY 14224

    Site contact: 716-712-1004

  • Lucas Research, Inc.

    Morehead City, NC 28557

    Site contact: 252-222-5700

  • Shelby Clinical Research

    Shelby, NC 28150

    Site contact: 980-552-9230

  • Providence Health Partners-Center for Clinical Research

    Dayton, OH 45439

    Site contact: 937-297-8994

  • Alliance for Multispecialty Research, LLC

    Norman, OK 73069

    Site contact: 405-701-8999

  • Frontier Clinical Research, LLC

    Scottdale, PA 15683

    Site contact: 724-220-5281

  • Juno Research

    Houston, TX 77040

    Site contact: 713-779-5494

  • Southern Endocrinology Associates

    Mesquite, TX 75149

    Site contact: 214-693-0904

  • Texas Diabetes & Endocrinology, P.A.

    Round Rock, TX 78681

    Site contact: 512-334-3505

  • Consano Clinical Research, LLC

    Shavano Park, TX 78231

    Site contact: 210-545-4900

  • Texas Valley Clinical Research

    Weslaco, TX 78596

    Site contact: 956-431-8090

  • Eastside Research Associates

    Redmond, WA 98052

    Site contact: 425-869-6828

Study contacts (from the official record)

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
  • Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
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