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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether LY3457263 lowers HbA1c (average blood sugar) compared with a placebo, which has no active study drug. It is for people with type 2 diabetes whose blood sugar is still above goal while taking a steady dose of semaglutide or tirzepatide. The study lasts about 9 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have type 2 diabetes.
  • Have an HbA1c (average blood sugar) of 7.5% to 10.5% at screening.
  • Have a BMI of 27 or higher at screening. BMI is a measure of weight compared with height.
  • Have had a steady body weight for the 3 months before screening.
  • Have taken the same dose of semaglutide or tirzepatide shots for at least 3 months before screening: semaglutide at 1 or 2 mg, or tirzepatide at 5, 7.5, 10, 12.5, or 15 mg.

Who can't join

  • Have type 1 diabetes or latent autoimmune diabetes, in which the body's defenses attack cells that make insulin.
  • Have ever had ketoacidosis (dangerous acid buildup in the blood) or hyperosmolar coma (coma from very high blood sugar).
  • Have had or plan to have weight-loss surgery.
  • Within 3 months before screening, had a heart attack, stroke, unstable angina (new or worsening heart-related chest pain), or a hospital stay for heart failure.
  • Used insulin to control blood sugar within the past year. Short-term use is allowed.
  • Take diabetes pills that the study does not allow, such as DPP-4 inhibitors or meglitinides, unless stopped at least 3 months before screening. Up to 3 allowed diabetes pills may be used at steady doses for at least 3 months: metformin, SGLT2 inhibitors, alpha-glucosidase inhibitors, sulfonylureas, or thiazolidinediones (TZDs).
  • Took any medicine or alternative remedy for weight loss within 3 months before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (25)

AZ

CA

FL

GA

ID

IN

NC

NJ

NY

OH

  • Providence Health Partners-Center for Clinical Research · Dayton, OH 45439 · Study contact · 937-297-8994Paul Opsahl · Principal investigatorMore trials in Dayton

OK

PA

TX

WA