RecruitingPhase 2NCT06897475
A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide
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
Sponsor
Eli Lilly and Company
Enrollment
240 participants
Start Date
Mar 28, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria7
- 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 Criteria11
- 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
DRUGLY3457263
Administered SC
DRUGPlacebo
Administered SC
Locations(56)
View Full Details on ClinicalTrials.gov
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NCT06897475
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