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
- Diseases
- Obesity, Type 2 diabetes
- 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
Sites (60)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centricity Research Brampton Endocrinology Coordinator of this site? Confirm its status | Brampton | Canada | Recruiting |
| Ecogene-21 Coordinator of this site? Confirm its status | Chicoutimi | Canada | Recruiting |
| Winterberry Research Inc. Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| Viacar Recherche Clinique Coordinator of this site? Confirm its status | Longueuil | Canada | Recruiting |
| G A Research Associates Coordinator of this site? Confirm its status | Moncton | Canada | Recruiting |
| Bluewater Clinical Research Group Inc. Coordinator of this site? Confirm its status | Sarnia | Canada | Recruiting |
| Diabetes Heart Research Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Maple Leaf Research Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Fadia El Boreky Medicine Coordinator of this site? Confirm its status | Waterloo | Canada | Recruiting |
| InnoDiab Forschung Gmbh Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut Coordinator of this site? Confirm its status | Leipzig | Germany | Active, not recruiting |
| Velocity Clinical Research, Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Active, not recruiting |
| Institut fuer Diabetesforschung Muenster GmbH Coordinator of this site? Confirm its status | Muenster | Germany | Active, not recruiting |
| R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH Coordinator of this site? Confirm its status | Oldenburg in Holstein | Germany | Active, not recruiting |
| FutureMeds - Birmingham Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| Layton Medical Centre Coordinator of this site? Confirm its status | Blackpool | United Kingdom | Recruiting |
| Southmead Hospital Coordinator of this site? Confirm its status | Bristol | United Kingdom | Recruiting |
| FutureMeds - Liverpool Coordinator of this site? Confirm its status | Bromborough | United Kingdom | Recruiting |
| Futuremeds-Newcastle Coordinator of this site? Confirm its status | Newcastle | United Kingdom | Recruiting |
| Newquay Health Centre Coordinator of this site? Confirm its status | Newquay | United Kingdom | Recruiting |
| George Eliot Hospital Coordinator of this site? Confirm its status | Nuneaton | United Kingdom | Recruiting |
| The Adam Practice Coordinator of this site? Confirm its status | Poole | United Kingdom | Recruiting |
| Clifton Medical Centre Coordinator of this site? Confirm its status | Rotherham | United Kingdom | Recruiting |
| Rame Group Practice Coordinator of this site? Confirm its status | Torpoint | United Kingdom | Recruiting |
| Legeartis Poradnie Specjalistyczne Sp. z o.o. Coordinator of this site? Confirm its status | Bialystok | Poland | Active, not recruiting |
| Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| EKAMED sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek Coordinator of this site? Confirm its status | Tarnów | Poland | Active, not recruiting |
| Szpital Czerniakowski Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| NBR Polska Coordinator of this site? Confirm its status | Warszawa | Poland | Active, not recruiting |
| 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Centro de Endocrinologia Alcantara Gonzalez Coordinator of this site? Confirm its status | Bayamón | Puerto Rico | Recruiting |
| Mgcendo Llc Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Recruiting |
| Investigators Research Group Coordinator of this site? Confirm its status | Brownsburg | United States | Recruiting |
| Providence Health Partners-Center for Clinical Research Coordinator of this site? Confirm its status | Dayton | United States | Recruiting |
| Juno Research Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Physicians Research Associates Coordinator of this site? Confirm its status | Lawrenceville | United States | Recruiting |
| Balanced Life Health Care Solutions/SKYCRNG Coordinator of this site? Confirm its status | Lawrenceville | United States | Recruiting |
| NYC Research Inc. Coordinator of this site? Confirm its status | Long Island City | United States | Recruiting |
| Southern Endocrinology Associates Coordinator of this site? Confirm its status | Mesquite | United States | Recruiting |
| Lucas Research, Inc. Coordinator of this site? Confirm its status | Morehead City | United States | Recruiting |
| Alliance for Multispecialty Research, LLC Coordinator of this site? Confirm its status | Norman | United States | Recruiting |
| Renstar Medical Research Coordinator of this site? Confirm its status | Ocala | United States | Recruiting |
| Oviedo Medical Research Coordinator of this site? Confirm its status | Oviedo | United States | Recruiting |
| Clinical Research of Philadelphia Coordinator of this site? Confirm its status | Pennington | United States | Recruiting |
| Helios Clinical Research - Phoenix Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Eastside Research Associates Coordinator of this site? Confirm its status | Redmond | United States | Recruiting |
| Elite Clinical Trials Coordinator of this site? Confirm its status | Rexburg | United States | Recruiting |
| Texas Diabetes & Endocrinology, P.A. Coordinator of this site? Confirm its status | Round Rock | United States | Recruiting |
| Wolverine Clinical Trials Coordinator of this site? Confirm its status | Santa Ana | United States | Recruiting |
| Frontier Clinical Research, LLC Coordinator of this site? Confirm its status | Scottdale | United States | Recruiting |
| Consano Clinical Research, LLC Coordinator of this site? Confirm its status | Shavano Park | United States | Recruiting |
| Shelby Clinical Research Coordinator of this site? Confirm its status | Shelby | United States | Recruiting |
| Richmond University Medical Center Coordinator of this site? Confirm its status | Staten Island | United States | Recruiting |
| Rophe Adult and Pediatric Medicine/SKYCRNG Coordinator of this site? Confirm its status | Union City | United States | Recruiting |
| Texas Valley Clinical Research Coordinator of this site? Confirm its status | Weslaco | United States | Recruiting |
| Southgate Medical Group Coordinator of this site? Confirm its status | West Seneca | United States | Recruiting |
| North Georgia Clinical Research Coordinator of this site? Confirm its status | Woodstock | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.