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

Phase 2

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: LY3457263; Drug: Placebo

• Registration Number: NCT06897475
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Study First Posted: 2025-03-27
• Study Start: 2025-03-28
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-09
• Primary Completion: 2026-12
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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:

  • 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3457263 Dose 1	LY3457263	Participants will receive LY3457263 subcutaneously (SC)
LY3457263 Dose 2	LY3457263	Participants will receive LY3457263 SC
LY3457263 Dose 3	LY3457263	Participants will receive LY3457263 SC
Placebo	Placebo	Participants will receive placebo SC

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 24

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Fasting Serum Glucose	Baseline, Week 24
Percent Change from Baseline in Body Weight	Baseline, Week 24

Trial Locations

Locations (56)

Helios Clinical Research - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Wolverine Clinical Trials; 🇺🇸 Santa Ana, California, United States

Renstar Medical Research; 🇺🇸 Ocala, Florida, United States

Oviedo Medical Research; 🇺🇸 Oviedo, Florida, United States

Balanced Life Health Care Solutions/SKYCRNG; 🇺🇸 Lawrenceville, Georgia, United States

Rophe Adult and Pediatric Medicine/SKYCRNG; 🇺🇸 Union City, Georgia, United States

Elite Clinical Trials; 🇺🇸 Rexburg, Idaho, United States

Investigators Research Group; 🇺🇸 Brownsburg, Indiana, United States

Richmond University Medical Center; 🇺🇸 Staten Island, New York, United States

Southgate Medical Group; 🇺🇸 West Seneca, New York, United States

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