GLP-1 Peptide Atlas, by Delfa

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

Lead sponsor

Eli Lilly and Company

Assets

Semaglutide / Tirzepatide

Listed sites

Recruiting sites

Enrollment

240

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•HbA1c 7.5-10.5%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06897475

Org study ID27344

Secondary ID2024-520328-27-00

Secondary IDJ1R-MC-GZFDEli Lilly and Company

Timeline

Milestones

Study first posted2025-03-27actual

Study start2025-03-28actual

Last update posted2026-05-22actual

Primary completion2026-12estimated (month precision)

Study completion2027-01estimated (month precision)

Assets

Investigational agents

Semaglutide Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 24

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in Fasting Serum Glucose

Time frame:Baseline, Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.