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

NCT ID
NCT06897475
Registry status
Recruiting
Study type
Not specified in the registry data
Phase
Phase 2
Sponsor
Eli Lilly and Company

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 200 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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 locations

60 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Canada, Germany, Poland, Puerto Rico, United Kingdom, United States

  • Arizona, United States: 1
  • California, United States: 1
  • Florida, United States: 2
  • Georgia, United States: 4
  • Idaho, United States: 1
  • Indiana, United States: 1
  • New Jersey, United States: 1
  • New York, United States: 3
  • North Carolina, United States: 2
  • Ohio, United States: 1
  • Oklahoma, United States: 1
  • Pennsylvania, United States: 1
  • Texas, United States: 5
  • Washington, United States: 1

Sample of listed locations

  • Centricity Research Brampton Endocrinology — Brampton, L6S 0C6, Canada — Site recruitment status not specified in the registry data
  • Ecogene-21 — Chicoutimi, G7H 7K9, Canada — Site recruitment status not specified in the registry data
  • Winterberry Research Inc. — Hamilton, L8J 0B6, Canada — Site recruitment status not specified in the registry data
  • Viacar Recherche Clinique — Longueuil, J4H 4B9, Canada — Site recruitment status not specified in the registry data
  • G A Research Associates — Moncton, E1G 1A7, Canada — Site recruitment status not specified in the registry data
  • Bluewater Clinical Research Group Inc. — Sarnia, N7T 4X3, Canada — Site recruitment status not specified in the registry data
  • Diabetes Heart Research Centre — Toronto, M6G 1M2, Canada — Site recruitment status not specified in the registry data
  • Maple Leaf Research — Toronto, M5G 1K2, Canada — Site recruitment status not specified in the registry data
  • Fadia El Boreky Medicine — Waterloo, N2J 1C4, Canada — Site recruitment status not specified in the registry data
  • InnoDiab Forschung Gmbh — Essen, 45136, Germany — Site recruitment status not specified in the registry data
  • Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut — Leipzig, 04249, Germany — Site recruitment status not specified in the registry data
  • Velocity Clinical Research, Leipzig — Leipzig, 04177, Germany — Site recruitment status not specified in the registry data
  • Institut für Diabetesforschung GmbH Münster — Münster, 48145, Germany — Site recruitment status not specified in the registry data
  • RED-Institut GmbH — Oldenburg, 23758, Germany — Site recruitment status not specified in the registry data
  • Legeartis - Poradnie Specjalistyczne — Bialystok, 15-404, Poland — Site recruitment status not specified in the registry data
  • Centrum Badan Klinicznych PI-House sp. z o.o. — Gdansk, 80-546, Poland — Site recruitment status not specified in the registry data
  • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET — Krakow, 31-261, Poland — Site recruitment status not specified in the registry data
  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna — Lodz, 90-338, Poland — Site recruitment status not specified in the registry data
  • Ekamed — Lublin, 20-718, Poland — Site recruitment status not specified in the registry data
  • Private Practice - Dr. Robert Witek — Tarnów, 33-100, Poland — Site recruitment status not specified in the registry data
  • NBR Polska — Warsaw, 00-710, Poland — Site recruitment status not specified in the registry data
  • Szpital Czerniakowski — Warsaw, 00-737, Poland — Site recruitment status not specified in the registry data
  • 4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ — Wroclaw, 50-981, Poland — Site recruitment status not specified in the registry data
  • Centro de Endocrinologia Alcantara Gonzalez — Bayamón, 00956, Puerto Rico — Site recruitment status not specified in the registry data
  • Mgcendo Llc — San Juan, 00921, Puerto Rico — Site recruitment status not specified in the registry data

Study details

Start date
March 28, 2025
Primary completion date
May 1, 2027
First posted
March 27, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06897475
Registry last updated
September 14, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT06897475 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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