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Recruiting Phase 2 NCT06897475

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

Phase 2 – studying effectiveness and dosage
Conditions: Type 2 Diabetes

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
LY3457263
DRUG
Placebo
DRUG
Locations 61
Canada (10)
Centricity Research Brampton Endocrinology
Brampton
Ecogene-21
Chicoutimi
Viacar Recherche Clinique
Greenfield Park
Winterberry Research Inc.
Hamilton
G A Research Associates
Moncton
Private Practice - Dr. James Cha
Oshawa
Bluewater Clinical Research Group Inc.
Sarnia
Maple Leaf Research
Toronto
Diabetes Heart Research Centre
Toronto
Fadia El Boreky Medicine
Waterloo
Germany (5)
InnoDiab Forschung Gmbh
Essen
Velocity Clinical Research, Leipzig
Leipzig
Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
Leipzig
Institut für Diabetesforschung GmbH Münster
Münster
RED-Institut GmbH
Oldenburg
Poland (9)
Legeartis - Poradnie Specjalistyczne
Bialystok
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
Krakow
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz
Ekamed
Lublin
Private Practice - Dr. Robert Witek
Tarnów
NBR Polska
Warsaw
Szpital Czerniakowski
Warsaw
4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Wroclaw
Puerto Rico (2)
Centro de Endocrinologia Alcantara Gonzalez
Bayamón
Mgcendo Llc
San Juan
United Kingdom (10)
FutureMeds - Birmingham
Birmingham
Layton Medical Centre
Blackpool
Southmead Hospital
Bristol
FutureMeds - Liverpool
Bromborough
Futuremeds-Newcastle
Newcastle
Newquay Health Centre
Newquay
George Eliot Hospital
Nuneaton
The Adam Practice
Poole
Clifton Medical Centre
Rotherham
Rame Group Practice
Torpoint
United States (25)
Investigators Research Group
Brownsburg , Indiana
Providence Health Partners-Center for Clinical Research
Dayton , Ohio
Juno Research
Houston , Texas
Balanced Life Health Care Solutions/SKYCRNG
Lawrenceville , Georgia
Physicians Research Associates
Lawrenceville , Georgia
NOT_YET_RECRUITING
NYC Research INC
Long Island City , New York
NOT_YET_RECRUITING
Southern Endocrinology Associates
Mesquite , Texas
Lucas Research, Inc.
Morehead City , North Carolina
Alliance for Multispecialty Research, LLC
Norman , Oklahoma
Renstar Medical Research
Ocala , Florida
Oviedo Medical Research
Oviedo , Florida
Clinical Research of Philadelphia
Pennington , New Jersey
NOT_YET_RECRUITING
Helios Clinical Research - Phoenix
Phoenix , Arizona
Eastside Research Associates
Redmond , Washington
Elite Clinical Trials
Rexburg , Idaho
Texas Diabetes & Endocrinology, P.A.
Round Rock , Texas
Wolverine Clinical Trials
Santa Ana , California
Frontier Clinical Research, LLC
Scottdale , Pennsylvania
NOT_YET_RECRUITING
Consano Clinical Research, LLC
Shavano Park , Texas
Shelby Clinical Research
Shelby , North Carolina
Richmond University Medical Center
Staten Island , New York
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City , Georgia
Texas Valley Clinical Research
Weslaco , Texas
Southgate Medical Group
West Seneca , New York
North Georgia Clinical Research
Woodstock , Georgia
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
28.03.2025
Completion date
01.01.2027
Registry ID
NCT06897475
Source
clinicaltrials.gov
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