RECRUITING

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

Description

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.

Conditions

Type 2 Diabetes
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Related Conditions:

Type 2 Diabetes

Study Overview

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Study Details

Study 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.

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

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

Condition
Type 2 Diabetes
Intervention / Treatment

-

Contacts and Locations

Phoenix

Helios Clinical Research - Phoenix, Phoenix, Arizona, United States, 85028

Tustin

Wolverine Clinical Trials, Tustin, California, United States, 92780

Ocala

Renstar Medical Research, Ocala, Florida, United States, 34471

Oviedo

Oviedo Medical Research, Oviedo, Florida, United States, 32765

Lawrenceville

Balanced Life Health Care Solutions/SKYCRNG, Lawrenceville, Georgia, United States, 30046

Union City

Rophe Adult and Pediatric Medicine/SKYCRNG, Union City, Georgia, United States, 30291

Rexburg

Elite Clinical Trials, Rexburg, Idaho, United States, 83440

Brownsburg

Investigators Research Group, Brownsburg, Indiana, United States, 46112

Staten Island

Richmond University Medical Center, Staten Island, New York, United States, 10310

West Seneca

Southgate Medical Group, West Seneca, New York, United States, 14224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • * Injectable semaglutide (1 and 2 milligram (mg))
  • * Injectable tirzepatide (5, 7.5, 10, 12.5 and 15 mg)
  • * 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 another oral antihyperglycemic medication (OAM) (including but not limited to, Dipeptidyl Peptidase IV Inhibitors (DPP-4i) and meglitinides) may be randomized if the additional 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 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2027-01