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HomeTrials › NCT06897475

Type 2 diabetes · Phase 2 · Recruiting now

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

NCT06897475 · Sponsor: Eli Lilly and Company

What this trial means for you

This study is recruiting now at 25 US sites. It's studying LY3457263, Placebo for type 2 diabetes.

Who can joinAll sexes, 18 Years – 75 Years
Healthy volunteersNo — diagnosis required
What you'd takeLY3457263, Placebo
Study length~20 months overall
Planned participants240
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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 sites by state

Arizona

  • Helios Clinical Research - Phoenix — Phoenix · Recruiting now

California

  • Wolverine Clinical Trials — Santa Ana · Recruiting now

Florida

  • Renstar Medical Research — Ocala · Recruiting now
  • Oviedo Medical Research — Oviedo · Recruiting now

Georgia

  • Balanced Life Health Care Solutions/SKYCRNG — Lawrenceville · Recruiting now
  • Physicians Research Associates — Lawrenceville · Opening soon
  • Rophe Adult and Pediatric Medicine/SKYCRNG — Union City · Recruiting now
  • North Georgia Clinical Research — Woodstock · Recruiting now

Idaho

  • Elite Clinical Trials — Rexburg · Recruiting now

Indiana

  • Investigators Research Group — Brownsburg · Recruiting now

New Jersey

  • Clinical Research of Philadelphia — Pennington · Opening soon

New York

  • NYC Research INC — Long Island City · Recruiting now
  • Richmond University Medical Center — Staten Island · Recruiting now
  • Southgate Medical Group — West Seneca · Recruiting now

North Carolina

  • Lucas Research, Inc. — Morehead City · Recruiting now
  • Shelby Clinical Research — Shelby · Recruiting now

Ohio

  • Providence Health Partners-Center for Clinical Research — Dayton · Recruiting now

Oklahoma

  • Alliance for Multispecialty Research, LLC — Norman · Recruiting now

Pennsylvania

  • Frontier Clinical Research, LLC — Scottdale · Opening soon

Texas

  • Juno Research — Houston · Recruiting now
  • Southern Endocrinology Associates — Mesquite · Recruiting now
  • Texas Diabetes & Endocrinology, P.A. — Round Rock · Recruiting now
  • Consano Clinical Research, LLC — Shavano Park · Recruiting now
  • Texas Valley Clinical Research — Weslaco · Recruiting now

Washington

  • Eastside Research Associates — Redmond · Recruiting now

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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