A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide
NCT ID: NCT06897475
Last Updated: 2026-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2025-03-28
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LY3457263 Dose 1
Participants will receive LY3457263 subcutaneously (SC)
LY3457263
Administered SC
LY3457263 Dose 2
Participants will receive LY3457263 SC
LY3457263
Administered SC
LY3457263 Dose 3
Participants will receive LY3457263 SC
LY3457263
Administered SC
Placebo
Participants will receive placebo SC
Placebo
Administered SC
Interventions
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LY3457263
Administered SC
Placebo
Administered SC
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
Elite Clinical Trials
Rexburg, Idaho, United States
Investigators Research Group
Brownsburg, Indiana, 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
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
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Facility Contacts
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Related Links
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A Study of LY3457263 Compared with Placebo in Participants with Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide
Other Identifiers
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2024-520328-27-00
Identifier Type: CTIS
Identifier Source: secondary_id
J1R-MC-GZFD
Identifier Type: OTHER
Identifier Source: secondary_id
27344
Identifier Type: -
Identifier Source: org_study_id
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