DRUG
LY3457263
Administered SC
Status
Recruiting
Phase
Phase 2
Enrollment
240
Locations
60
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Administered SC
DRUG
Administered SC
Timeline
First posted
Mar 27, 2025
Study start
Mar 28, 2025
Primary completion
Dec 2026
Study completion
Jan 2027
Results posted
Not reported
Registry updated
Jul 20, 2026
Outcomes
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame · Baseline, Week 24
Change from Baseline in Fasting Serum Glucose
Time frame · Baseline, Week 24
Percent Change from Baseline in Body Weight
Time frame · Baseline, Week 24
Eligibility
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
Canada · Germany · Poland · Puerto Rico · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
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