Comparing LY3457263 to placebo for type 2 diabetes patients on semaglutide or tirzepatide

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of LY3457263 in lowering hemoglobin A1c (HbA1c) levels compared to a placebo in individuals with type 2 diabetes who are currently on a stable dose of either semaglutide or tirzepatide. Participants must have an HbA1c level between 7.5% and 10.5% and a body mass index (BMI) of 27 kg/m2 or higher. The study will last approximately 9 months, during which the changes in HbA1c will be closely monitored. The goal is to determine if LY3457263 can help patients achieve better glycemic control.

Why it matters

Who can join: the full rules

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's running

• Helios Clinical Research - Phoenix
  Phoenix, Arizona, United States Recruiting
• Wolverine Clinical Trials
  Santa Ana, California, United States Recruiting
• Renstar Medical Research
  Ocala, Florida, United States Recruiting
• Oviedo Medical Research
  Oviedo, Florida, United States Recruiting
• Balanced Life Health Care Solutions/SKYCRNG
  Lawrenceville, Georgia, United States Recruiting
• Physicians Research Associates
  Lawrenceville, Georgia, United States Recruiting

+10 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.