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

Lilly

Status and phase: Begins enrollment this month; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: LY3457263; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06897475

J1R-MC-GZFD (Other Identifier)

2024-520328-27-00 (EU Trial (CTIS) Number)

27344

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 4 patient groups, including a placebo group

LY3457263 Dose 1

Experimental group

Description:

Participants will receive LY3457263 subcutaneously (SC)

Treatment:

Drug: LY3457263

LY3457263 Dose 2

Experimental group

Description:

Participants will receive LY3457263 SC

Treatment:

Drug: LY3457263

LY3457263 Dose 3

Experimental group

Description:

Participants will receive LY3457263 SC

Treatment:

Drug: LY3457263

Placebo

Placebo Comparator group

Description:

Participants will receive placebo SC

Treatment:

Drug: Placebo