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

NCT06897475

RecruitingPhase 2

Sponsor: Eli Lilly and Company

Conditions: Type 2 Diabetes

Interventions: LY3457263, Placebo

Countries: United States, Canada, Germany, Poland, Puerto Rico, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (60)
  • Phoenix, Arizona, United States
  • Santa Ana, California, United States
  • Ocala, Florida, United States
  • Oviedo, Florida, United States
  • Lawrenceville, Georgia, United States
  • Lawrenceville, Georgia, United States
  • Union City, Georgia, United States
  • Woodstock, Georgia, United States
  • Rexburg, Idaho, United States
  • Brownsburg, Indiana, United States
  • Pennington, New Jersey, United States
  • Long Island City, New York, United States
  • Staten Island, New York, United States
  • West Seneca, New York, United States
  • Morehead City, North Carolina, United States
  • Shelby, North Carolina, United States
  • Dayton, Ohio, United States
  • Norman, Oklahoma, United States
  • Scottdale, Pennsylvania, United States
  • Houston, Texas, United States
  • Mesquite, Texas, United States
  • Round Rock, Texas, United States
  • Shavano Park, Texas, United States
  • Weslaco, Texas, United States
  • Redmond, Washington, United States
  • Brampton, Canada
  • Chicoutimi, Canada
  • Hamilton, Canada
  • Longueuil, Canada
  • Moncton, Canada
  • + 30 more on CT.gov