Current partner codePEPTIDESDE
NCT06897475·Phase 2·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 2

Enrollment

240

Locations

60

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

LY3457263

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Mar 27, 2025

  2. Study start

    Mar 28, 2025

  3. Primary completion

    Dec 2026

  4. Study completion

    Jan 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 20, 2026

Outcomes

What the study measures.

Primary outcomes

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame · Baseline, Week 24

Secondary outcomes

Change from Baseline in Fasting Serum Glucose

Time frame · Baseline, Week 24

Percent Change from Baseline in Body Weight

Time frame · Baseline, Week 24

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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 locations

60 registered sites.

Canada · Germany · Poland · Puerto Rico · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

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

Physicians Research Associates

Lawrenceville, Georgia, United States

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States

North Georgia Clinical Research

Woodstock, Georgia, United States

Elite Clinical Trials

Rexburg, Idaho, United States

Investigators Research Group

Brownsburg, Indiana, United States

Clinical Research of Philadelphia

Pennington, New Jersey, United States

NYC Research INC

Long Island City, New York, United States

Richmond University Medical Center

Staten Island, New York, United States

Southgate Medical Group

West Seneca, New York, United States

Lucas Research, Inc.

Morehead City, North Carolina, United States

Shelby Clinical Research

Shelby, North Carolina, United States

Providence Health Partners-Center for Clinical Research

Dayton, Ohio, United States

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, United States

Frontier Clinical Research, LLC

Scottdale, Pennsylvania, United States

Juno Research

Houston, Texas, United States

Southern Endocrinology Associates

Mesquite, Texas, United States

Texas Diabetes & Endocrinology, P.A.

Round Rock, Texas, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Texas Valley Clinical Research

Weslaco, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Tirzepatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.