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

May 20, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Canada
      • Brampton, Canada, L6S 0C6
        • Recruiting
        • Centricity Research Brampton Endocrinology
        • Principal Investigator:
          • Harpreet Bajaj
        • Contact:
          • Phone Number: 905 595 0560
      • Chicoutimi, Canada, G7H 7K9
        • Recruiting
        • Ecogene-21
        • Principal Investigator:
          • Daniel Gaudet
        • Contact:
          • Phone Number: 418-545-1252
      • Hamilton, Canada, L8J 0B6
        • Recruiting
        • Winterberry Research Inc.
        • Principal Investigator:
          • Steven Zizzo
        • Contact:
          • Phone Number: 365-366-6267
      • Longueuil, Canada, J4H 4B9
        • Recruiting
        • Viacar Recherche Clinique
        • Principal Investigator:
          • Genevieve Mathieu
      • Moncton, Canada, E1G 1A7
        • Recruiting
        • G A Research Associates
        • Principal Investigator:
          • Jocelyn Cormier
        • Contact:
          • Phone Number: 506-852-9865
      • Sarnia, Canada, N7T 4X3
        • Recruiting
        • Bluewater Clinical Research Group Inc.
        • Principal Investigator:
          • John O'Mahony
        • Contact:
          • Phone Number: 1 (519) 344-6612
      • Toronto, Canada, M5G 1K2
        • Recruiting
        • Maple Leaf Research
        • Principal Investigator:
          • Graham Smith
        • Contact:
          • Phone Number: 4164657936
      • Toronto, Canada, M6G 1M2
        • Recruiting
        • Diabetes Heart Research Centre
        • Principal Investigator:
          • Luis Noronha
        • Contact:
          • Phone Number: 4169245871
      • Waterloo, Canada, N2J 1C4
        • Recruiting
        • Fadia El Boreky Medicine
        • Principal Investigator:
          • Fadia El Boreky
        • Contact:
          • Phone Number: 519-569-7592
  • Germany
      • Essen, Germany, 45136
        • Recruiting
        • InnoDiab Forschung GmbH
        • Principal Investigator:
          • Helga Zeller
        • Contact:
          • Phone Number: 49 201 89942100
      • Leipzig, Germany, 04177
        • Recruiting
        • Velocity Clinical Research, Leipzig
        • Principal Investigator:
          • Thomas Mueller
        • Contact:
          • Phone Number: +4934126825556
      • Leipzig, Germany, 04249
        • Recruiting
        • Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
        • Contact:
          • Phone Number: 00493414247103
        • Principal Investigator:
          • Heidrun Taeschner
      • Münster, Germany, 48145
        • Recruiting
        • Institut für Diabetesforschung GmbH Münster
        • Principal Investigator:
          • Ludger Rose
        • Contact:
          • Phone Number: 0049 251 935 2321
      • Oldenburg, Germany, 23758
        • Recruiting
        • Red-Institut GmbH
        • Principal Investigator:
          • Thomas Schaum
        • Contact:
          • Phone Number: 0049436150630128
  • Poland
      • Bialystok, Poland, 15-404
        • Recruiting
        • Legeartis - Poradnie Specjalistyczne
        • Principal Investigator:
          • Anna Modzelewska
        • Contact:
          • Phone Number: 48 507 18 11 18
      • Gdansk, Poland, 80-546
        • Recruiting
        • Centrum Badan Klinicznych PI-House sp. z o.o.
        • Contact:
          • Phone Number: 48603790004
        • Principal Investigator:
          • Monika Lukaszewicz
      • Krakow, Poland, 31-261
        • Recruiting
        • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
        • Contact:
          • Phone Number: 48126237122
        • Principal Investigator:
          • Joanna Mirocka
      • Lodz, Poland, 90-338
        • Recruiting
        • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
        • Contact:
          • Phone Number: 607536360
        • Principal Investigator:
          • Malgorzata Jozefowska
      • Lublin, Poland, 20-718
        • Recruiting
        • Ekamed
        • Principal Investigator:
          • Ewa Skokowska
        • Contact:
          • Phone Number: 48603787884
      • Tarnów, Poland, 33-100
        • Recruiting
        • Private Practice - Dr. Robert Witek
        • Principal Investigator:
          • Robert Witek
        • Contact:
          • Phone Number: 48721000040
      • Warsaw, Poland, 00-710
        • Recruiting
        • NBR Polska
        • Contact:
          • Phone Number: 48514876203
        • Principal Investigator:
          • Katarzyna Klodawska
      • Warsaw, Poland, 00-737
        • Recruiting
        • Szpital Czerniakowski
        • Contact:
          • Phone Number: 4847722052
        • Principal Investigator:
          • Olga Turowska
      • Wroclaw, Poland, 50-981
        • Recruiting
        • 4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
        • Contact:
          • Phone Number: 71 7210 873
        • Principal Investigator:
          • Mateusz Tabin
  • Puerto Rico
      • Bayamón, Puerto Rico, 00956
        • Recruiting
        • Centro de Endocrinologia Alcantara Gonzalez
        • Contact:
          • Phone Number: 7877870933
        • Principal Investigator:
          • Altagracia Alcantara-Gonzalez
      • San Juan, Puerto Rico, 00921
        • Recruiting
        • Mgcendo Llc
        • Contact:
          • Phone Number: 7874842757
        • Principal Investigator:
          • Martha Gomez-Cuellar
  • United Kingdom
      • Birmingham, United Kingdom, B21 9RY
        • Recruiting
        • FutureMeds - Birmingham
        • Principal Investigator:
          • Tehmina Ahmed
        • Contact:
          • Phone Number: 0121 592 2050
      • Blackpool, United Kingdom, FY3 7EN
        • Recruiting
        • Layton Medical Centre
        • Contact:
          • Phone Number: 441253951943
        • Principal Investigator:
          • Rebecca Clark
      • Bristol, United Kingdom, BS10 5NB
        • Recruiting
        • Southmead Hospital
        • Principal Investigator:
          • Georgina Russell
        • Contact:
          • Phone Number: 0117 4148125
      • Bromborough, United Kingdom, CH62 6EE
        • Recruiting
        • FutureMeds - Liverpool
        • Principal Investigator:
          • Connor McGladdery
        • Contact:
          • Phone Number: 01513150090
      • Newcastle, United Kingdom, NE6 1SG
        • Recruiting
        • Futuremeds-Newcastle
        • Principal Investigator:
          • Martin Johnson
        • Contact:
          • Phone Number: 07775506109
      • Newquay, United Kingdom, TR7 1RU
        • Recruiting
        • Newquay Health Centre
        • Contact:
          • Phone Number: 01637857903
        • Principal Investigator:
          • Rutesh Patel
      • Nuneaton, United Kingdom, CV10 7DJ
        • Recruiting
        • George Eliot Hospital
        • Principal Investigator:
          • Ponnusamy Saravanan
        • Contact:
          • Phone Number: 02476153592
      • Poole, United Kingdom, BH16 5PW
        • Recruiting
        • The Adam Practice
        • Contact:
          • Phone Number: 01202 339050
        • Principal Investigator:
          • Patrick Moore
      • Rotherham, United Kingdom, S65 1DA
        • Recruiting
        • Clifton Medical Centre
        • Contact:
          • Phone Number: 01709363950
        • Principal Investigator:
          • Matthew Capehorn
      • Torpoint, United Kingdom, PL11 2TB
        • Recruiting
        • Rame Group Practice
        • Contact:
          • Phone Number: (0044) 1752 817900
        • Principal Investigator:
          • Susan Keast
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85028
        • Recruiting
        • Helios Clinical Research - Phoenix
        • Principal Investigator:
          • David Francyk
        • Contact:
          • Phone Number: 480-372-5996
    • California
      • Santa Ana, California, United States, 92706
        • Recruiting
        • Wolverine Clinical Trials
        • Contact:
          • Phone Number: 714-617-2426
        • Principal Investigator:
          • Behnam Khaleghi
    • Florida
      • Ocala, Florida, United States, 34471
        • Recruiting
        • Renstar Medical Research
        • Contact:
          • Phone Number: 352-629-5800
        • Principal Investigator:
          • David Oliver
      • Oviedo, Florida, United States, 32765
        • Recruiting
        • Oviedo Medical Research
        • Contact:
          • Phone Number: 407-977-2705
        • Principal Investigator:
          • Bradley Block
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Recruiting
        • Balanced Life Health Care Solutions/SKYCRNG
        • Principal Investigator:
          • Nadia Cameron, MD
        • Contact:
          • Phone Number: 770-696-4541
      • Lawrenceville, Georgia, United States, 30046
        • Not yet recruiting
        • Physicians Research Associates
        • Contact:
          • Phone Number: 678-252-2375
        • Principal Investigator:
          • Ola Odugbesan
      • Union City, Georgia, United States, 30291
        • Recruiting
        • Rophe Adult and Pediatric Medicine/SKYCRNG
        • Principal Investigator:
          • Dwight Blake
        • Contact:
          • Phone Number: 470-317-3604
      • Woodstock, Georgia, United States, 30189
        • Recruiting
        • North Georgia Clinical Research
        • Contact:
          • Phone Number: 678-494-5735
        • Principal Investigator:
          • Bram Wieskopf
    • Idaho
      • Rexburg, Idaho, United States, 83440
        • Recruiting
        • Elite Clinical Trials
        • Contact:
          • Phone Number: 208-356-8977
        • Principal Investigator:
          • Brian Beesley
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Recruiting
        • Investigators Research Group
        • Contact:
          • Phone Number: 317-852-8280
        • Principal Investigator:
          • Kenneth Maynard
    • New Jersey
      • Pennington, New Jersey, United States, 08534
        • Not yet recruiting
        • Clinical Research of Philadelphia
        • Contact:
          • Phone Number: 215-676-6696
        • Principal Investigator:
          • Taher Modarressi
    • New York
      • Long Island City, New York, United States, 11106
        • Recruiting
        • NYC Research INC
        • Principal Investigator:
          • Anastasios Manessis
        • Contact:
          • Phone Number: 516-574-9232
      • Staten Island, New York, United States, 10310
        • Recruiting
        • Richmond University Medical Center
        • Principal Investigator:
          • Philip Otterbeck
        • Contact:
          • Phone Number: 718-818-2430
      • West Seneca, New York, United States, 14224
        • Recruiting
        • Southgate Medical Group
        • Contact:
          • Phone Number: 716-712-1004
        • Principal Investigator:
          • Brian Snyder
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Lucas Research, Inc.
        • Principal Investigator:
          • Kathryn Lucas
        • Contact:
          • Phone Number: 252-222-5700
      • Shelby, North Carolina, United States, 28150
        • Recruiting
        • Shelby Clinical Research
        • Principal Investigator:
          • Christian Martin
        • Contact:
          • Phone Number: 980-552-9230
    • Ohio
      • Dayton, Ohio, United States, 45439
        • Recruiting
        • Providence Health Partners-Center for Clinical Research
        • Principal Investigator:
          • Paul Opsahl
        • Contact:
          • Phone Number: 937-297-8994
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Recruiting
        • Alliance for Multispecialty Research, LLC
        • Contact:
          • Phone Number: 405-701-8999
        • Principal Investigator:
          • Lisa Connery
    • Pennsylvania
      • Scottdale, Pennsylvania, United States, 15683
        • Not yet recruiting
        • Frontier Clinical Research, LLC
        • Principal Investigator:
          • Tiffany Pluto
        • Contact:
          • Phone Number: 724-220-5281
    • Texas
      • Houston, Texas, United States, 77040
        • Recruiting
        • Juno Research
        • Contact:
          • Phone Number: 713-779-5494
        • Principal Investigator:
          • Damaris Vega
      • Mesquite, Texas, United States, 75149
        • Recruiting
        • Southern Endocrinology Associates
        • Contact:
          • Phone Number: 214-693-0904
        • Principal Investigator:
          • Sumana Gangi
      • Round Rock, Texas, United States, 78681
        • Recruiting
        • Texas Diabetes & Endocrinology, P.A.
        • Contact:
          • Phone Number: 512-334-3505
        • Principal Investigator:
          • Srujana Yada
      • Shavano Park, Texas, United States, 78231
        • Recruiting
        • Consano Clinical Research, LLC
        • Contact:
          • Phone Number: 210-545-4900
        • Principal Investigator:
          • Michelle Welch
      • Weslaco, Texas, United States, 78596
        • Recruiting
        • Texas Valley Clinical Research
        • Principal Investigator:
          • Eduardo Luna
        • Contact:
          • Phone Number: 956-431-8090
    • Washington
      • Redmond, Washington, United States, 98052
        • Recruiting
        • Eastside Research Associates
        • Contact:
          • Phone Number: 425-869-6828
        • Principal Investigator:
          • Chad Crystal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3457263 Dose 1
Participants will receive LY3457263 subcutaneously (SC)
Drug: LY3457263
Administered SC
Experimental: LY3457263 Dose 2
Participants will receive LY3457263 SC
Drug: LY3457263
Administered SC
Experimental: LY3457263 Dose 3
Participants will receive LY3457263 SC
Drug: LY3457263
Administered SC
Placebo Comparator: Placebo
Participants will receive placebo SC
Drug: Placebo
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 24
Baseline, Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Fasting Serum Glucose
Time Frame: Baseline, Week 24
Baseline, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

March 27, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27344
  • 2024-520328-27-00 (Ctis)
  • J1R-MC-GZFD (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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