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

Last updated: April 16, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Obesity

Diabetes And Hypertension

Hypertriglyceridemia

Treatment

Placebo

LY3457263

Clinical Study ID

NCT06897475
27344
J1R-MC-GZFD
2024-520328-27-00
  • Ages 18-75
  • All Genders

Study 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

Inclusion

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 monthsprior to screening:

  • Injectable semaglutide (1 and 2 milligram (mg))

  • Injectable tirzepatide (5, 7.5, 10, 12.5 and 15 mg)

Exclusion

Exclusion Criteria:

  • Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis orhyperosmolar coma

  • Have a prior or planned surgical treatment for obesity

  • Have any of the following cardiovascular conditions within three months prior toscreening:

  • 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 useallowed)

  • Current use of prohibited oral antihyperglycemic medication (OAM) (including but notlimited to, Dipeptidyl Peptidase IV Inhibitors (DPP-4i) and meglitinides) may berandomized if the prohibited OAM treatment was discontinued at least 3 months priorto screening

  • If participant has been on stable doses (for at least three months) of up tothree permitted OAMs (limited to metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, alpha-glucosidase inhibitors, sulfonylurea, and/orthiazolidinediones (TZD), they are permitted to participate in the study

  • Have taken any medications or alternative remedies for weight loss within threemonths prior to screening

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 28, 2025
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Centricity Research Brampton Endocrinology

    Brampton, L6S 0C6
    Canada

    Active - Recruiting

  • Centricity Research Brampton Endocrinology

    Brampton 5907364, L6S 0C6
    Canada

    Site Not Available

  • Ecogene-21

    Chicoutimi, G7H 7K9
    Canada

    Active - Recruiting

  • Ecogene-21

    Chicoutimi 5921225, G7H 7K9
    Canada

    Site Not Available

  • Viacar Recherche Clinique

    Greenfield Park, J4V 2G8
    Canada

    Active - Recruiting

  • Viacar Recherche Clinique

    Greenfield Park 5966078, J4V 2G8
    Canada

    Site Not Available

  • Winterberry Research Inc.

    Hamilton, L8J 0B6
    Canada

    Active - Recruiting

  • Winterberry Research Inc.

    Hamilton 5969782, L8J 0B6
    Canada

    Site Not Available

  • G A Research Associates

    Moncton, E1G 1A7
    Canada

    Active - Recruiting

  • G A Research Associates

    Moncton 6076211, E1G 1A7
    Canada

    Site Not Available

  • Private Practice - Dr. James Cha

    Oshawa, L1J 2K1
    Canada

    Active - Recruiting

  • Private Practice - Dr. James Cha

    Oshawa 6094578, L1J 2K1
    Canada

    Site Not Available

  • Bluewater Clinical Research Group Inc.

    Sarnia, N7T 4X3
    Canada

    Active - Recruiting

  • Bluewater Clinical Research Group Inc.

    Sarnia 6141190, N7T 4X3
    Canada

    Site Not Available

  • Diabetes Heart Research Centre

    Toronto, M6G 1M2
    Canada

    Active - Recruiting

  • Maple Leaf Research

    Toronto, M5G 1K2
    Canada

    Active - Recruiting

  • Diabetes Heart Research Centre

    Toronto 6167865, M6G 1M2
    Canada

    Active - Recruiting

  • Maple Leaf Research

    Toronto 6167865, M5G 1K2
    Canada

    Site Not Available

  • Fadia El Boreky Medicine

    Waterloo, N2J 1C4
    Canada

    Active - Recruiting

  • Fadia El Boreky Medicine

    Waterloo 6176823, N2J 1C4
    Canada

    Site Not Available

  • InnoDiab Forschung Gmbh

    Essen, 45136
    Germany

    Active - Recruiting

  • InnoDiab Forschung Gmbh

    Essen 2928810, 45136
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut

    Leipzig, 04249
    Germany

    Active - Recruiting

  • Velocity Clinical Research, Leipzig

    Leipzig, 04177
    Germany

    Active - Recruiting

  • Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut

    Leipzig 2879139, 04249
    Germany

    Site Not Available

  • Velocity Clinical Research, Leipzig

    Leipzig 2879139, 04177
    Germany

    Active - Recruiting

  • Institut für Diabetesforschung GmbH Münster

    Münster, 48145
    Germany

    Active - Recruiting

  • Institut für Diabetesforschung GmbH Münster

    Münster 2867543, 48145
    Germany

    Site Not Available

  • RED-Institut GmbH

    Oldenburg, 23758
    Germany

    Active - Recruiting

  • RED-Institut GmbH

    Oldenburg 2857458, 23758
    Germany

    Site Not Available

  • NBR Polska

    Warszawa, Mazowieckie 00-710
    Poland

    Site Not Available

  • Szpital Czerniakowski

    Warszawa, Mazowieckie 00-737
    Poland

    Site Not Available

  • Legeartis - Poradnie Specjalistyczne

    Bialystok, 15-404
    Poland

    Active - Recruiting

  • Legeartis - Poradnie Specjalistyczne

    Bialystok 776069, 15-404
    Poland

    Site Not Available

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

    Gdansk, 80-546
    Poland

    Active - Recruiting

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

    Gdansk 3099434, 80-546
    Poland

    Site Not Available

  • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

    Krakow, 31-261
    Poland

    Active - Recruiting

  • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

    Krakow 3094802, 31-261
    Poland

    Site Not Available

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

    Lodz, 90-338
    Poland

    Active - Recruiting

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

    Lodz 3093133, 90-338
    Poland

    Site Not Available

  • Ekamed

    Lublin, 20-718
    Poland

    Active - Recruiting

  • Ekamed

    Lublin 765876, 20-718
    Poland

    Site Not Available

  • Private Practice - Dr. Robert Witek

    Tarnów, 33-100
    Poland

    Active - Recruiting

  • Private Practice - Dr. Robert Witek

    Tarnów 757026, 33-100
    Poland

    Site Not Available

  • NBR Polska

    Warsaw, 00-710
    Poland

    Active - Recruiting

  • Szpital Czerniakowski

    Warsaw, 00-737
    Poland

    Active - Recruiting

  • NBR Polska

    Warsaw 756135, 00-710
    Poland

    Active - Recruiting

  • Szpital Czerniakowski

    Warsaw 756135, 00-737
    Poland

    Site Not Available

  • 4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ

    Wroclaw, 50-981
    Poland

    Active - Recruiting

  • 4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ

    Wroclaw 3081368, 50-981
    Poland

    Site Not Available

  • Centro de Endocrinologia Alcantara Gonzalez

    Bayamon, 00956
    Puerto Rico

    Site Not Available

  • Centro de Endocrinologia Alcantara Gonzalez

    Bayamón, 00956
    Puerto Rico

    Active - Recruiting

  • Centro de Endocrinologia Alcantara Gonzalez

    Bayamón 4562831, 00956
    Puerto Rico

    Site Not Available

  • Mgcendo Llc

    San Juan, 00921
    Puerto Rico

    Active - Recruiting

  • Mgcendo Llc

    San Juan 4568127, 00921
    Puerto Rico

    Site Not Available

  • FutureMeds - Birmingham

    Birmingham, B21 9RY
    United Kingdom

    Active - Recruiting

  • FutureMeds - Birmingham

    Birmingham 2655603, B21 9RY
    United Kingdom

    Site Not Available

  • Layton Medical Centre

    Blackpool, FY3 7EN
    United Kingdom

    Active - Recruiting

  • Layton Medical Centre

    Blackpool 2655459, FY3 7EN
    United Kingdom

    Site Not Available

  • Southmead Hospital

    Bristol, BS10 5NB
    United Kingdom

    Active - Recruiting

  • Southmead Hospital

    Bristol 2654675, BS10 5NB
    United Kingdom

    Site Not Available

  • FutureMeds - Liverpool

    Bromborough, CH62 6EE
    United Kingdom

    Active - Recruiting

  • FutureMeds - Liverpool

    Bromborough 2654596, CH62 6EE
    United Kingdom

    Site Not Available

  • Futuremeds-Newcastle

    Newcastle, NE6 1SG
    United Kingdom

    Active - Recruiting

  • Futuremeds-Newcastle

    Newcastle 6695976, NE6 1SG
    United Kingdom

    Site Not Available

  • Newquay Health Centre

    Newquay, TR7 1RU
    United Kingdom

    Active - Recruiting

  • Newquay Health Centre

    Newquay 2641589, TR7 1RU
    United Kingdom

    Site Not Available

  • George Eliot Hospital

    Nuneaton, CV10 7DJ
    United Kingdom

    Active - Recruiting

  • George Eliot Hospital

    Nuneaton 2641157, CV10 7DJ
    United Kingdom

    Site Not Available

  • The Adam Practice

    Poole, BH16 5PW
    United Kingdom

    Active - Recruiting

  • The Adam Practice

    Poole 2640101, BH16 5PW
    United Kingdom

    Site Not Available

  • Clifton Medical Centre

    Rotherham, S65 1DA
    United Kingdom

    Active - Recruiting

  • Clifton Medical Centre

    Rotherham 2639093, S65 1DA
    United Kingdom

    Site Not Available

  • Rame Group Practice

    Torpoint, PL11 2TB
    United Kingdom

    Active - Recruiting

  • Rame Group Practice

    Torpoint 2635651, PL11 2TB
    United Kingdom

    Site Not Available

  • Helios Clinical Research - Phoenix

    Phoenix, Arizona 85028
    United States

    Active - Recruiting

  • Helios Clinical Research - Phoenix

    Phoenix 5308655, Arizona 5551752 85028
    United States

    Site Not Available

  • Wolverine Clinical Trials

    Santa Ana, California 92706
    United States

    Active - Recruiting

  • Wolverine Clinical Trials

    Tustin, California 92780
    United States

    Site Not Available

  • Wolverine Clinical Trials

    Santa Ana 5392900, California 5332921 92706
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34471
    United States

    Active - Recruiting

  • Oviedo Medical Research

    Oviedo, Florida 32765
    United States

    Active - Recruiting

  • Renstar Medical Research

    Ocala 4166673, Florida 4155751 34471
    United States

    Site Not Available

  • Oviedo Medical Research

    Oviedo 4167348, Florida 4155751 32765
    United States

    Site Not Available

  • Balanced Life Health Care Solutions/SKYCRNG

    Lawrenceville, Georgia 30046
    United States

    Active - Recruiting

  • Physicians Research Associates

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia 30291
    United States

    Active - Recruiting

  • North Georgia Clinical Research

    Woodstock, Georgia 30189
    United States

    Site Not Available

  • Balanced Life Health Care Solutions/SKYCRNG

    Lawrenceville 4205196, Georgia 4197000 30046
    United States

    Site Not Available

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City 4227777, Georgia 4197000 30291
    United States

    Site Not Available

  • Elite Clinical Trials

    Rexburg, Idaho 83440
    United States

    Active - Recruiting

  • Elite Clinical Trials

    Rexburg 5605242, Idaho 5596512 83440
    United States

    Site Not Available

  • Investigators Research Group

    Brownsburg, Indiana 46112
    United States

    Active - Recruiting

  • Investigators Research Group

    Brownsburg 4255056, Indiana 4921868 46112
    United States

    Site Not Available

  • Clinical Research of Philadelphia

    Pennington, New Jersey 08534
    United States

    Site Not Available

  • NYC Research INC

    Long Island City, New York 11106
    United States

    Site Not Available

  • Richmond University Medical Center

    Staten Island, New York 10310
    United States

    Active - Recruiting

  • Southgate Medical Group

    West Seneca, New York 14224
    United States

    Active - Recruiting

  • Richmond University Medical Center

    Staten Island 5139568, New York 5128638 10310
    United States

    Site Not Available

  • Southgate Medical Group

    West Seneca 5143992, New York 5128638 14224
    United States

    Site Not Available

  • Lucas Research, Inc.

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Shelby Clinical Research

    Shelby, North Carolina 28150
    United States

    Active - Recruiting

  • Lucas Research, Inc.

    Morehead City 4480153, North Carolina 4482348 28557
    United States

    Site Not Available

  • Shelby Clinical Research

    Shelby 4491180, North Carolina 4482348 28150
    United States

    Site Not Available

  • Providence Health Partners-Center for Clinical Research

    Dayton, Ohio 45439
    United States

    Active - Recruiting

  • Providence Health Partners-Center for Clinical Research

    Dayton 4509884, Ohio 5165418 45439
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma 73069
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC

    Norman 4543762, Oklahoma 4544379 73069
    United States

    Site Not Available

  • Frontier Clinical Research, LLC

    Scottdale, Pennsylvania 15683
    United States

    Site Not Available

  • Juno Research

    Houston, Texas 77040
    United States

    Active - Recruiting

  • Southern Endocrinology Associates

    Mesquite, Texas 75149
    United States

    Active - Recruiting

  • Texas Diabetes & Endocrinology, P.A.

    Round Rock, Texas 78681
    United States

    Active - Recruiting

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Active - Recruiting

  • Texas Valley Clinical Research

    Weslaco, Texas 78596
    United States

    Active - Recruiting

  • Juno Research

    Houston 4699066, Texas 4736286 77040
    United States

    Site Not Available

  • Southern Endocrinology Associates

    Mesquite 4710826, Texas 4736286 75149
    United States

    Site Not Available

  • Texas Diabetes & Endocrinology, P.A.

    Round Rock 4724129, Texas 4736286 78681
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park 4728147, Texas 4736286 78231
    United States

    Site Not Available

  • Texas Valley Clinical Research

    Weslaco 4740629, Texas 4736286 78596
    United States

    Site Not Available

  • Eastside Research Associates

    Redmond, Washington 98052
    United States

    Active - Recruiting

  • Eastside Research Associates

    Redmond 5808079, Washington 5815135 98052
    United States

    Site Not Available

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