A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide
Recruiting · NCT06897475 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
LY3457263Placebo
What this trial is about
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 take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 14 US states.
- Helios Clinical Research - Phoenix - Phoenix, Arizona, United States
- Wolverine Clinical Trials - Santa Ana, California, United States
- Renstar Medical Research - Ocala, Florida, United States
- Oviedo Medical Research - Oviedo, Florida, United States
- Balanced Life Health Care Solutions/SKYCRNG - Lawrenceville, Georgia, United States
- Physicians Research Associates - Lawrenceville, Georgia, United States
- Rophe Adult and Pediatric Medicine/SKYCRNG - Union City, Georgia, United States
- North Georgia Clinical Research - Woodstock, Georgia, United States
- Elite Clinical Trials - Rexburg, Idaho, United States
- Investigators Research Group - Brownsburg, Indiana, United States
- Clinical Research of Philadelphia - Pennington, New Jersey, United States
- NYC Research INC - Long Island City, New York, United States
- Richmond University Medical Center - Staten Island, New York, United States
- Southgate Medical Group - West Seneca, New York, United States
- Lucas Research, Inc. - Morehead City, North Carolina, United States
- Shelby Clinical Research - Shelby, North Carolina, United States
- Providence Health Partners-Center for Clinical Research - Dayton, Ohio, United States
- Alliance for Multispecialty Research, LLC - Norman, Oklahoma, United States
- Frontier Clinical Research, LLC - Scottdale, Pennsylvania, United States
- Juno Research - Houston, Texas, United States
- Southern Endocrinology Associates - Mesquite, Texas, United States
- Texas Diabetes & Endocrinology, P.A. - Round Rock, Texas, United States
- Consano Clinical Research, LLC - Shavano Park, Texas, United States
- Texas Valley Clinical Research - Weslaco, Texas, United States
- Eastside Research Associates - Redmond, Washington, United States
- Centro de Endocrinologia Alcantara Gonzalez - Bayamón, Puerto Rico
- Legeartis - Poradnie Specjalistyczne - Bialystok, Poland
- FutureMeds - Birmingham - Birmingham, United Kingdom
- Layton Medical Centre - Blackpool, United Kingdom
- Centricity Research Brampton Endocrinology - Brampton, Canada
- Southmead Hospital - Bristol, United Kingdom
- FutureMeds - Liverpool - Bromborough, United Kingdom
- Ecogene-21 - Chicoutimi, Canada
- InnoDiab Forschung Gmbh - Essen, Germany
- Centrum Badan Klinicznych PI-House sp. z o.o. - Gdansk, Poland
- Winterberry Research Inc. - Hamilton, Canada
- Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET - Krakow, Poland
- Velocity Clinical Research, Leipzig - Leipzig, Germany
- Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut - Leipzig, Germany
- Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna - Lodz, Poland
- Viacar Recherche Clinique - Longueuil, Canada
- Ekamed - Lublin, Poland
- G A Research Associates - Moncton, Canada
- Institut für Diabetesforschung GmbH Münster - Münster, Germany
- Futuremeds-Newcastle - Newcastle, United Kingdom
- Newquay Health Centre - Newquay, United Kingdom
- George Eliot Hospital - Nuneaton, United Kingdom
- RED-Institut GmbH - Oldenburg, Germany
- The Adam Practice - Poole, United Kingdom
- Clifton Medical Centre - Rotherham, United Kingdom
- Mgcendo Llc - San Juan, Puerto Rico
- Bluewater Clinical Research Group Inc. - Sarnia, Canada
- Private Practice - Dr. Robert Witek - Tarnów, Poland
- Maple Leaf Research - Toronto, Canada
- Diabetes Heart Research Centre - Toronto, Canada
- Rame Group Practice - Torpoint, United Kingdom
- NBR Polska - Warsaw, Poland
- Szpital Czerniakowski - Warsaw, Poland
- Fadia El Boreky Medicine - Waterloo, Canada
- 4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ - Wroclaw, Poland