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
Status: Recruiting
Location: See all (56) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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)
Locations
United States
Arizona
Helios Clinical Research - Phoenix
RECRUITING
Phoenix
California
Wolverine Clinical Trials
RECRUITING
Santa Ana
Florida
Renstar Medical Research
RECRUITING
Ocala
Oviedo Medical Research
RECRUITING
Oviedo
Georgia
Balanced Life Health Care Solutions/SKYCRNG
RECRUITING
Lawrenceville
Rophe Adult and Pediatric Medicine/SKYCRNG
RECRUITING
Union City
Idaho
Elite Clinical Trials
RECRUITING
Rexburg
Indiana
Investigators Research Group
RECRUITING
Brownsburg
North Carolina
Lucas Research, Inc.
RECRUITING
Morehead City
Shelby Clinical Research
RECRUITING
Shelby
New York
Richmond University Medical Center
RECRUITING
Staten Island
Southgate Medical Group
RECRUITING
West Seneca
Ohio
Providence Health Partners-Center for Clinical Research
RECRUITING
Dayton
Oklahoma
Alliance for Multispecialty Research, LLC
RECRUITING
Norman
Texas
Juno Research
RECRUITING
Houston
Southern Endocrinology Associates
RECRUITING
Mesquite
Texas Diabetes & Endocrinology, P.A.
RECRUITING
Round Rock
Consano Clinical Research, LLC
RECRUITING
Shavano Park
Texas Valley Clinical Research
RECRUITING
Weslaco
Washington
Eastside Research Associates
RECRUITING
Redmond
Other Locations
Canada
Centricity Research Brampton Endocrinology
RECRUITING
Brampton
Ecogene-21
RECRUITING
Chicoutimi
Viacar Recherche Clinique
RECRUITING
Greenfield Park
Winterberry Research Inc.
RECRUITING
Hamilton
G A Research Associates
RECRUITING
Moncton
Private Practice - Dr. James Cha
RECRUITING
Oshawa
Bluewater Clinical Research Group Inc.
RECRUITING
Sarnia
Diabetes Heart Research Centre
RECRUITING
Toronto
Maple Leaf Research
RECRUITING
Toronto
Fadia El Boreky Medicine
RECRUITING
Waterloo
Germany
InnoDiab Forschung Gmbh
RECRUITING
Essen
Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
RECRUITING
Leipzig
Velocity Clinical Research, Leipzig
RECRUITING
Leipzig
Institut für Diabetesforschung GmbH Münster
RECRUITING
Münster
RED-Institut GmbH
RECRUITING
Oldenburg
Poland
Legeartis - Poradnie Specjalistyczne
RECRUITING
Bialystok
Centrum Badan Klinicznych PI-House sp. z o.o.
NOT_YET_RECRUITING
Gdansk
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
RECRUITING
Krakow
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
RECRUITING
Lodz
Ekamed
RECRUITING
Lublin
Private Practice - Dr. Robert Witek
RECRUITING
Tarnów
NBR Polska
RECRUITING
Warsaw
Szpital Czerniakowski
NOT_YET_RECRUITING
Warsaw
4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
NOT_YET_RECRUITING
Wroclaw
Puerto Rico
Centro de Endocrinologia Alcantara Gonzalez
RECRUITING
Bayamón
Mgcendo Llc
RECRUITING
San Juan
United Kingdom
FutureMeds - Birmingham
RECRUITING
Birmingham
Layton Medical Centre
RECRUITING
Blackpool
Southmead Hospital
RECRUITING
Bristol
FutureMeds - Liverpool
RECRUITING
Bromborough
Futuremeds-Newcastle
RECRUITING
Newcastle
Newquay Health Centre
RECRUITING
Newquay
George Eliot Hospital
RECRUITING
Nuneaton
The Adam Practice
RECRUITING
Poole
Clifton Medical Centre
RECRUITING
Rotherham
Rame Group Practice
RECRUITING
Torpoint
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-03-28
Estimated Completion Date: 2027-01
Participants
Target number of participants: 240
Treatments
Experimental: LY3457263 Dose 1
Participants will receive LY3457263 subcutaneously (SC)
Experimental: LY3457263 Dose 2
Participants will receive LY3457263 SC
Experimental: LY3457263 Dose 3
Participants will receive LY3457263 SC
Placebo_comparator: Placebo
Participants will receive placebo SC
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company