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NCT06897475RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
200 (estimated)
First submitted
25 Mar 2025
Start date
28 Mar 2025
Primary completion date
May 2027
Lead sponsor
Eli Lilly and Company
NCT number
NCT06897475
EU CT number
2024-520328-27-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 200
  • From 28 Mar 2025 to the primary completion date, May 2027
  • 60 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 taken any medications or alternative remedies for weight loss within three months prior to screening

Other illness

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

Lab values

  • 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

Who the study is looking for

  • 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)

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (60)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centricity Research Brampton Endocrinology
Coordinator of this site? Confirm its status
BramptonCanadaRecruiting
Ecogene-21
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ChicoutimiCanadaRecruiting
Winterberry Research Inc.
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HamiltonCanadaRecruiting
Viacar Recherche Clinique
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LongueuilCanadaRecruiting
G A Research Associates
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MonctonCanadaRecruiting
Bluewater Clinical Research Group Inc.
Coordinator of this site? Confirm its status
SarniaCanadaRecruiting
Diabetes Heart Research Centre
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Maple Leaf Research
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TorontoCanadaRecruiting
Fadia El Boreky Medicine
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WaterlooCanadaRecruiting
InnoDiab Forschung Gmbh
Coordinator of this site? Confirm its status
EssenGermanyActive, not recruiting
Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
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LeipzigGermanyActive, not recruiting
Velocity Clinical Research, Leipzig
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LeipzigGermanyActive, not recruiting
Institut fuer Diabetesforschung Muenster GmbH
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MuensterGermanyActive, not recruiting
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
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Oldenburg in HolsteinGermanyActive, not recruiting
FutureMeds - Birmingham
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BirminghamUnited KingdomRecruiting
Layton Medical Centre
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BlackpoolUnited KingdomRecruiting
Southmead Hospital
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BristolUnited KingdomRecruiting
FutureMeds - Liverpool
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BromboroughUnited KingdomRecruiting
Futuremeds-Newcastle
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NewcastleUnited KingdomRecruiting
Newquay Health Centre
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NewquayUnited KingdomRecruiting
George Eliot Hospital
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NuneatonUnited KingdomRecruiting
The Adam Practice
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PooleUnited KingdomRecruiting
Clifton Medical Centre
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RotherhamUnited KingdomRecruiting
Rame Group Practice
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TorpointUnited KingdomRecruiting
Legeartis Poradnie Specjalistyczne Sp. z o.o.
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BialystokPolandActive, not recruiting
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
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CracowPolandActive, not recruiting
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandActive, not recruiting
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
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LodzPolandActive, not recruiting
EKAMED sp. z o.o.
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LublinPolandActive, not recruiting
Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek
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TarnówPolandActive, not recruiting
Szpital Czerniakowski Sp. z o.o.
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WarsawPolandActive, not recruiting
NBR Polska
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WarszawaPolandActive, not recruiting
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
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WroclawPolandActive, not recruiting
Centro de Endocrinologia Alcantara Gonzalez
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BayamónPuerto RicoRecruiting
Mgcendo Llc
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San JuanPuerto RicoRecruiting
Investigators Research Group
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BrownsburgUnited StatesRecruiting
Providence Health Partners-Center for Clinical Research
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DaytonUnited StatesRecruiting
Juno Research
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HoustonUnited StatesRecruiting
Physicians Research Associates
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LawrencevilleUnited StatesRecruiting
Balanced Life Health Care Solutions/SKYCRNG
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LawrencevilleUnited StatesRecruiting
NYC Research Inc.
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Long Island CityUnited StatesRecruiting
Southern Endocrinology Associates
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MesquiteUnited StatesRecruiting
Lucas Research, Inc.
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Morehead CityUnited StatesRecruiting
Alliance for Multispecialty Research, LLC
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NormanUnited StatesRecruiting
Renstar Medical Research
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OcalaUnited StatesRecruiting
Oviedo Medical Research
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OviedoUnited StatesRecruiting
Clinical Research of Philadelphia
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PenningtonUnited StatesRecruiting
Helios Clinical Research - Phoenix
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PhoenixUnited StatesRecruiting
Eastside Research Associates
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RedmondUnited StatesRecruiting
Elite Clinical Trials
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RexburgUnited StatesRecruiting
Texas Diabetes & Endocrinology, P.A.
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Round RockUnited StatesRecruiting
Wolverine Clinical Trials
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Santa AnaUnited StatesRecruiting
Frontier Clinical Research, LLC
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ScottdaleUnited StatesRecruiting
Consano Clinical Research, LLC
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Shavano ParkUnited StatesRecruiting
Shelby Clinical Research
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ShelbyUnited StatesRecruiting
Richmond University Medical Center
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Staten IslandUnited StatesRecruiting
Rophe Adult and Pediatric Medicine/SKYCRNG
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Union CityUnited StatesRecruiting
Texas Valley Clinical Research
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WeslacoUnited StatesRecruiting
Southgate Medical Group
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West SenecaUnited StatesRecruiting
North Georgia Clinical Research
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WoodstockUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.