CClinicalTrials.gg
RecruitingNCT06897475Updated Sep 14, 2026

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

A Phase 2 interventional study of LY3457263 and Placebo in Type 2 Diabetes, sponsored by Eli Lilly and Company. Recruiting at 60 sites in 6 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 6 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Obesity
  • Overweight
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 200 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    LY3457263 Dose 1

    Participants will receive LY3457263 subcutaneously (SC)

    Drug: LY3457263

  • Experimental
    LY3457263 Dose 2

    Participants will receive LY3457263 SC

    Drug: LY3457263

  • Experimental
    LY3457263 Dose 3

    Participants will receive LY3457263 SC

    Drug: LY3457263

  • Placebo comparator
    Placebo

    Participants will receive placebo SC

    Drug: Placebo

Interventions

  • DrugLY3457263

    Administered SC

  • DrugPlacebo

    Administered SC

06

What researchers measure

Primary outcomes

  1. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 24

Secondary outcomes

  1. Change from Baseline in Fasting Serum Glucose

    Time frame: Baseline, Week 24

  2. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 24

07

Study locations

56 of 60 sites recruiting
  • Helios Clinical Research - Phoenix
    Phoenix, Arizona 85028, United States
    • · Contact · 480-372-5996
    • David Francyk · Principal investigator
    Recruiting
  • Wolverine Clinical Trials
    Santa Ana, California 92706, United States
    • · Contact · 714-617-2426
    • Behnam Khaleghi · Principal investigator
    Recruiting
  • Renstar Medical Research
    Ocala, Florida 34471, United States
    • · Contact · 3526295800
    • David Oliver · Principal investigator
    Recruiting
  • Oviedo Medical Research
    Oviedo, Florida 32765, United States
    • · Contact · 407-977-2705
    • Bradley Block · Principal investigator
    Recruiting
  • Balanced Life Health Care Solutions/SKYCRNG
    Lawrenceville, Georgia 30046, United States
    • · Contact · 770-696-4541
    • Nadia Cameron, MD · Principal investigator
    Recruiting
  • Physicians Research Associates
    Lawrenceville, Georgia 30046, United States
    • · Contact · 678-252-2375
    • Ola Odugbesan · Principal investigator
    Recruiting
  • Rophe Adult and Pediatric Medicine/SKYCRNG
    Union City, Georgia 30291, United States
    • · Contact · 470-317-3604
    • Dwight Blake · Principal investigator
    Recruiting
  • North Georgia Clinical Research
    Woodstock, Georgia 30189, United States
    • · Contact · 6784945735
    • Bram Wieskopf · Principal investigator
    Recruiting
  • Elite Clinical Trials
    Rexburg, Idaho 83440, United States
    • · Contact · 208 356-8977
    • Brian Beesley · Principal investigator
    Recruiting
  • Investigators Research Group
    Brownsburg, Indiana 46112, United States
    • · Contact · 3178528280
    • Kenneth Maynard · Principal investigator
    Recruiting
  • Clinical Research of Philadelphia
    Pennington, New Jersey 08534, United States
    • · Contact · 215-676-6696
    • Taher Modarressi · Principal investigator
    Recruiting
  • NYC Research INC
    Long Island City, New York 11106, United States
    • · Contact · 516-574-9232
    • Anastasios Manessis · Principal investigator
    Recruiting
  • Richmond University Medical Center
    Staten Island, New York 10310, United States
    • Lina Leykina · Principal investigator
    Recruiting
  • Southgate Medical Group
    West Seneca, New York 14224, United States
    • · Contact · 7167121004
    • Brian Snyder · Principal investigator
    Recruiting
  • Lucas Research, Inc.
    Morehead City, North Carolina 28557, United States
    • · Contact · 252-222-5700
    • Kathryn Lucas · Principal investigator
    Recruiting
  • Shelby Clinical Research
    Shelby, North Carolina 28150, United States
    • · Contact · 9805529230
    • Christian Martin · Principal investigator
    Recruiting
  • Providence Health Partners-Center for Clinical Research
    Dayton, Ohio 45439, United States
    • · Contact · 937-297-8994
    • Paul Opsahl · Principal investigator
    Recruiting
  • Alliance for Multispecialty Research, LLC
    Norman, Oklahoma 73069, United States
    • · Contact · 4057018999
    • Lisa Connery · Principal investigator
    Recruiting
  • Frontier Clinical Research, LLC
    Scottdale, Pennsylvania 15683, United States
    • · Contact · 724-220-5281
    • Tiffany Pluto · Principal investigator
    Recruiting
  • Juno Research
    Houston, Texas 77040, United States
    • · Contact · 713-779-5494
    • Damaris Vega · Principal investigator
    Recruiting
  • Southern Endocrinology Associates
    Mesquite, Texas 75149, United States
    • · Contact · 214-693-0904
    • Sumana Gangi · Principal investigator
    Recruiting
  • Texas Diabetes & Endocrinology, P.A.
    Round Rock, Texas 78681, United States
    • · Contact · 512-334-3505
    • Srujana Yada · Principal investigator
    Recruiting
  • Consano Clinical Research, LLC
    Shavano Park, Texas 78231, United States
    • · Contact · 210-545-4900
    • Michelle Welch · Principal investigator
    Recruiting
  • Texas Valley Clinical Research
    Weslaco, Texas 78596, United States
    • · Contact · 956-431-8090
    • Eduardo Luna · Principal investigator
    Recruiting
  • Eastside Research Associates
    Redmond, Washington 98052, United States
    • · Contact · 4258696828
    • Chad Crystal · Principal investigator
    Recruiting
  • Centricity Research Brampton Endocrinology
    Brampton, L6S 0C6, Canada
    • · Contact · 905 595 0560
    • Harpreet Bajaj · Principal investigator
    Recruiting
  • Ecogene-21
    Chicoutimi, G7H 7K9, Canada
    • · Contact · 418-545-1252
    • Daniel Gaudet · Principal investigator
    Recruiting
  • Winterberry Research Inc.
    Hamilton, L8J 0B6, Canada
    • · Contact · 365-366-6267
    • Steven Zizzo · Principal investigator
    Recruiting
  • Viacar Recherche Clinique
    Longueuil, J4H 4B9, Canada
    • Genevieve Mathieu · Principal investigator
    Recruiting
  • G A Research Associates
    Moncton, E1G 1A7, Canada
    • · Contact · 506-852-9865
    • Jocelyn Cormier · Principal investigator
    Recruiting
  • Bluewater Clinical Research Group Inc.
    Sarnia, N7T 4X3, Canada
    • · Contact · 1 (519) 344-6612
    • John O'Mahony · Principal investigator
    Recruiting
  • Maple Leaf Research
    Toronto, M5G 1K2, Canada
    • · Contact · 4164657936
    • Graham Smith · Principal investigator
    Recruiting
  • Diabetes Heart Research Centre
    Toronto, M6G 1M2, Canada
    • · Contact · 4169245871
    • Luis Noronha · Principal investigator
    Recruiting
  • Fadia El Boreky Medicine
    Waterloo, N2J 1C4, Canada
    • · Contact · 519-569-7592
    • Fadia El Boreky · Principal investigator
    Recruiting
  • InnoDiab Forschung Gmbh
    Essen, 45136, Germany
    Completed
  • Velocity Clinical Research, Leipzig
    Leipzig, 04177, Germany
    • · Contact · +4934126825556
    • Thomas Mueller · Principal investigator
    Recruiting
  • Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
    Leipzig, 04249, Germany
    Completed
  • Institut für Diabetesforschung GmbH Münster
    Münster, 48145, Germany
    Active, not recruiting
  • RED-Institut GmbH
    Oldenburg, 23758, Germany
    Active, not recruiting
  • Legeartis - Poradnie Specjalistyczne
    Bialystok, 15-404, Poland
    • · Contact · 48 507 18 11 18
    • Anna Modzelewska · Principal investigator
    Recruiting
  • Centrum Badan Klinicznych PI-House sp. z o.o.
    Gdansk, 80-546, Poland
    • · Contact · 48603790004
    • Monika Lukaszewicz · Principal investigator
    Recruiting
  • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
    Krakow, 31-261, Poland
    • · Contact · 48126237122
    • Joanna Mirocka · Principal investigator
    Recruiting
  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
    Lodz, 90-338, Poland
    • · Contact · 607536360
    • Malgorzata Jozefowska · Principal investigator
    Recruiting
  • Ekamed
    Lublin, 20-718, Poland
    • · Contact · 48603787884
    • Ewa Skokowska · Principal investigator
    Recruiting
  • Private Practice - Dr. Robert Witek
    Tarnów, 33-100, Poland
    • · Contact · 48721000040
    • Robert Witek · Principal investigator
    Recruiting
  • NBR Polska
    Warsaw, 00-710, Poland
    • · Contact · 48514876203
    • Katarzyna Klodawska · Principal investigator
    Recruiting
  • Szpital Czerniakowski
    Warsaw, 00-737, Poland
    • · Contact · 4847722052
    • Olga Turowska · Principal investigator
    Recruiting
  • 4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
    Wroclaw, 50-981, Poland
    • · Contact · 71 7210 873
    • Mateusz Tabin · Principal investigator
    Recruiting
  • Centro de Endocrinologia Alcantara Gonzalez
    Bayamón, 00956, Puerto Rico
    • · Contact · 7877870933
    • Altagracia Alcantara-Gonzalez · Principal investigator
    Recruiting
  • Mgcendo Llc
    San Juan, 00921, Puerto Rico
    • · Contact · 7874842757
    • Martha Gomez-Cuellar · Principal investigator
    Recruiting
  • FutureMeds - Birmingham
    Birmingham, B21 9RY, United Kingdom
    • · Contact · 0121 592 2050
    • Tehmina Ahmed · Principal investigator
    Recruiting
  • Layton Medical Centre
    Blackpool, FY3 7EN, United Kingdom
    • · Contact · 441253951943
    • Rebecca Clark · Principal investigator
    Recruiting
  • Southmead Hospital
    Bristol, BS10 5NB, United Kingdom
    • · Contact · 0117 4148125
    • Georgina Russell · Principal investigator
    Recruiting
  • FutureMeds - Liverpool
    Bromborough, CH62 6EE, United Kingdom
    • · Contact · 01513150090
    • Connor McGladdery · Principal investigator
    Recruiting
  • Futuremeds-Newcastle
    Newcastle, NE6 1SG, United Kingdom
    • · Contact · 07775506109
    • Martin Johnson · Principal investigator
    Recruiting
  • Newquay Health Centre
    Newquay, TR7 1RU, United Kingdom
    • · Contact · 01637857903
    • Rutesh Patel · Principal investigator
    Recruiting
  • George Eliot Hospital
    Nuneaton, CV10 7DJ, United Kingdom
    • · Contact · 02476153592
    • Ponnusamy Saravanan · Principal investigator
    Recruiting
  • The Adam Practice
    Poole, BH16 5PW, United Kingdom
    • · Contact · 01202 339050
    • Patrick Moore · Principal investigator
    Recruiting
  • Clifton Medical Centre
    Rotherham, S65 1DA, United Kingdom
    • · Contact · 01709363950
    • Matthew Capehorn · Principal investigator
    Recruiting
  • Rame Group Practice
    Torpoint, PL11 2TB, United Kingdom
    • · Contact · (0044) 1752 817900
    • Susan Keast · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06897475
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Mar 27, 2025
Start date
Mar 28, 2025
Primary completion
May 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 14, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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