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NCT06897475PHASE2Recruiting

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

Start Date

3/28/2025

Completion Date

1/1/2027

Summary

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.

Eligibility Criteria

Age Range: 18 years to 75 years

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

Interventions

DRUG

LY3457263

DRUG

Placebo

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Conditions

Type 2 Diabetes

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

Clinical Research of Philadelphia

Pennington, New Jersey 08534

United States

NYC Research INC

Long Island City, New York 11106

United States

Richmond University Medical Center

Staten Island, New York 10310

United States

Southgate Medical Group

West Seneca, New York 14224

United States

Lucas Research, Inc.

Morehead City, North Carolina 28557

United States

Shelby Clinical Research

Shelby, North Carolina 28150

United States

Providence Health Partners-Center for Clinical Research

Dayton, Ohio 45439

United States

Alliance for Multispecialty Research, LLC

Norman, Oklahoma 73069

United States

Frontier Clinical Research, LLC

Scottdale, Pennsylvania 15683

United States

Juno Research

Houston, Texas 77040

United States

Southern Endocrinology Associates

Mesquite, Texas 75149

United States

Texas Diabetes & Endocrinology, P.A.

Round Rock, Texas 78681

United States

Consano Clinical Research, LLC

Shavano Park, Texas 78231

United States

Texas Valley Clinical Research

Weslaco, Texas 78596

United States

Eastside Research Associates

Redmond, Washington 98052

United States

Centricity Research Brampton Endocrinology

Brampton, L6S 0C6

Canada

Ecogene-21

Chicoutimi, G7H 7K9

Canada

Winterberry Research Inc.

Hamilton, L8J 0B6

Canada

Viacar Recherche Clinique

Longueuil, J4H 4B9

Canada

G A Research Associates

Moncton, E1G 1A7

Canada

Bluewater Clinical Research Group Inc.

Sarnia, N7T 4X3

Canada

Maple Leaf Research

Toronto, M5G 1K2

Canada

Diabetes Heart Research Centre

Toronto, M6G 1M2

Canada

Fadia El Boreky Medicine

Waterloo, N2J 1C4

Canada

InnoDiab Forschung Gmbh

Essen, 45136

Germany

Velocity Clinical Research, Leipzig

Leipzig, 04177

Germany

Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut

Leipzig, 04249

Germany

Institut für Diabetesforschung GmbH Münster

Münster, 48145

Germany

RED-Institut GmbH

Oldenburg, 23758

Germany

Legeartis - Poradnie Specjalistyczne

Bialystok, 15-404

Poland

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, 80-546

Poland

Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

Krakow, 31-261

Poland

Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, 90-338

Poland

Ekamed

Lublin, 20-718

Poland

Private Practice - Dr. Robert Witek

Tarnów, 33-100

Poland

NBR Polska

Warsaw, 00-710

Poland

Szpital Czerniakowski

Warsaw, 00-737

Poland

4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ

Wroclaw, 50-981

Poland

Centro de Endocrinologia Alcantara Gonzalez

Bayamón, 00956

Puerto Rico

Mgcendo Llc

San Juan, 00921

Puerto Rico

FutureMeds - Birmingham

Birmingham, B21 9RY

United Kingdom

Layton Medical Centre

Blackpool, FY3 7EN

United Kingdom

Southmead Hospital

Bristol, BS10 5NB

United Kingdom

FutureMeds - Liverpool

Bromborough, CH62 6EE

United Kingdom

Futuremeds-Newcastle

Newcastle, NE6 1SG

United Kingdom

Newquay Health Centre

Newquay, TR7 1RU

United Kingdom

George Eliot Hospital

Nuneaton, CV10 7DJ

United Kingdom

The Adam Practice

Poole, BH16 5PW

United Kingdom

Clifton Medical Centre

Rotherham, S65 1DA

United Kingdom

Rame Group Practice

Torpoint, PL11 2TB

United Kingdom