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Comparing LY3457263 to placebo for type 2 diabetes patients on 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

Phase 2 Interventional Eli Lilly and Company · NCT06897475

This study is testing if a new medication called LY3457263 can help people with type 2 diabetes who are already using semaglutide or tirzepatide lower their blood sugar levels better than a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations61 sites (Phoenix, Arizona and 60 other locations)
Trial IDNCT06897475 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with type 2 diabetes, HbA1c levels between 7.5% and 10.5%, and a BMI of 27 kg/m2 or higher who are stable on semaglutide or tirzepatide.

Not a fit: Patients with type 1 diabetes, recent cardiovascular events, or those who have undergone obesity surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could help patients with type 2 diabetes achieve better blood sugar control.

How similar studies have performed: Other studies have shown promising results with similar approaches in managing type 2 diabetes, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Phoenix, Arizona and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Type 2 DiabetesObesityOverweight
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.