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
3 other identifiers
interventional
240
6 countries
60
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes
Started Mar 2025
Typical duration for phase_2 type-2-diabetes
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2025
CompletedFirst Posted
Study publicly available on registry
March 27, 2025
CompletedStudy Start
First participant enrolled
March 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
May 22, 2026
May 1, 2026
1.7 years
March 25, 2025
May 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Hemoglobin A1c (HbA1c)
Baseline, Week 24
Secondary Outcomes (2)
Change from Baseline in Fasting Serum Glucose
Baseline, Week 24
Percent Change from Baseline in Body Weight
Baseline, Week 24
Study Arms (4)
LY3457263 Dose 1
EXPERIMENTALParticipants will receive LY3457263 subcutaneously (SC)
LY3457263 Dose 2
EXPERIMENTALParticipants will receive LY3457263 SC
LY3457263 Dose 3
EXPERIMENTALParticipants will receive LY3457263 SC
Placebo
PLACEBO COMPARATORParticipants will receive placebo SC
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2025
First Posted
March 27, 2025
Study Start
March 28, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.