RecruitingPhase 2NCT06897475

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

A Parallel-Group Treatment, Phase 2, Double-Blind Study of Once-Weekly Subcutaneous LY3457263 Compared to Placebo in Participants With Type 2 Diabetes Mellitus on a Stable Dose of Semaglutide or Tirzepatide Who Failed to Achieve HbA1c Goal

Sponsor

Eli Lilly and Company

Enrollment

240 participants

Start Date

Mar 28, 2025

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called LY3457263 as an add-on treatment for people with type 2 diabetes who are already taking semaglutide or tirzepatide (injectable medications that help lower blood sugar and body weight) but still have blood sugar levels that are not well controlled. The goal is to find out whether adding LY3457263 can further improve blood sugar and weight outcomes beyond what these medications achieve alone. **You may be eligible if...** - You have type 2 diabetes - Your HbA1c (a measure of average blood sugar) is between 7.5% and 10.5% - Your BMI is 27 or above - You have been on a stable dose of injectable semaglutide (1 mg or 2 mg) or tirzepatide for at least 3 months - Your body weight has been stable for at least 3 months **You may NOT be eligible if...** - You have type 1 diabetes or a history of diabetic ketoacidosis - You have had a heart attack, stroke, or were hospitalized for heart failure in the past 3 months - You have used insulin to control blood sugar in the past year - You are on certain other diabetes medications (like DPP-4 inhibitors) - You have had or are planning weight loss surgery - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY3457263

Administered SC

DRUGPlacebo

Administered SC

Locations(61)

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

Richmond University Medical Center

Staten Island, New York, United States

Southgate Medical Group

West Seneca, New York, United States

Lucas Research, Inc.

Morehead City, North Carolina, United States

Shelby Clinical Research

Shelby, North Carolina, United States

Providence Health Partners-Center for Clinical Research

Dayton, Ohio, United States

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, United States

Frontier Clinical Research, LLC

Scottdale, Pennsylvania, United States

Juno Research

Houston, Texas, United States

Southern Endocrinology Associates

Mesquite, Texas, United States

Texas Diabetes & Endocrinology, P.A.

Round Rock, Texas, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Texas Valley Clinical Research

Weslaco, Texas, United States

Eastside Research Associates

Redmond, Washington, United States

Centricity Research Brampton Endocrinology

Brampton, Canada

Ecogene-21

Chicoutimi, Canada

Viacar Recherche Clinique

Greenfield Park, Canada

Winterberry Research Inc.

Hamilton, Canada

G A Research Associates

Moncton, Canada

Private Practice - Dr. James Cha

Oshawa, Canada

Bluewater Clinical Research Group Inc.

Sarnia, Canada

Maple Leaf Research

Toronto, Canada

Diabetes Heart Research Centre

Toronto, Canada

Fadia El Boreky Medicine

Waterloo, Canada

InnoDiab Forschung Gmbh

Essen, Germany

Velocity Clinical Research, Leipzig

Leipzig, Germany

Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut

Leipzig, Germany

Institut für Diabetesforschung GmbH Münster

Münster, Germany

RED-Institut GmbH

Oldenburg, Germany

Legeartis - Poradnie Specjalistyczne

Bialystok, Poland

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

Gdansk, Poland

Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

Krakow, Poland

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

Lodz, Poland

Ekamed

Lublin, Poland

Private Practice - Dr. Robert Witek

Tarnów, Poland

NBR Polska

Warsaw, Poland

Szpital Czerniakowski

Warsaw, Poland

4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ

Wroclaw, Poland

Centro de Endocrinologia Alcantara Gonzalez

Bayamón, Puerto Rico

Mgcendo Llc

San Juan, Puerto Rico

FutureMeds - Birmingham

Birmingham, United Kingdom

Layton Medical Centre

Blackpool, United Kingdom

Southmead Hospital

Bristol, United Kingdom

FutureMeds - Liverpool

Bromborough, United Kingdom

Futuremeds-Newcastle

Newcastle, United Kingdom

Newquay Health Centre

Newquay, United Kingdom

George Eliot Hospital

Nuneaton, United Kingdom

The Adam Practice

Poole, United Kingdom

Clifton Medical Centre

Rotherham, United Kingdom

Rame Group Practice

Torpoint, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06897475

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