CompletedPhase 1

A Study of LY3457263 in Healthy Participants and Participants With Type 2 Diabetes

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3457263 in Healthy Participants and in Patients With Type 2 Diabetes

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers, Type 2 diabetes

Eligibility highlights

•BMI 18.5-35•Healthy volunteers

Primary endpoint

•Serious AEs (any)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04641312

Org study ID17261

Secondary ID2020-001828-34

Secondary IDJ1R-MC-GZFAEli Lilly and Company

Timeline

Milestones

Study first posted2020-11-23actual

Study start2020-11-25actual

Primary completion2021-12-21actual

Study completion2021-12-21actual

Last update posted2022-01-11actual

Assets

Investigational agents

Dulaglutide

Who this study enrolls

Healthy volunteersType 2 diabetes

Who can enroll

Minimum age20 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Males that agree to use an effective method of contraception or agree to remain abstinent

•Females that are not of childbearing potential due to postmenopausal status or due to surgical sterility

•Part A only:

-Are overtly healthy

-Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²)

•Part B only:

-Have been diagnosed with Type 2 Diabetes (T2D) for at least 6 months prior to screening

-Be treated for T2D with stable dose of metformin, a stable dose of a dipeptidyl peptidase-4 (DPP-4) inhibitor with or without metformin, or a stable dose of a glucagon-like peptide-1 (GLP-1) receptor agonist with or without metformin for at least 3 months prior to screening

-BMI of 27 to 40 kg/m²

Exclusion criteria

•Have undergone any form of bariatric surgery

-Have used or intend to use medications that promote weight loss within 3 months prior to screening, for the duration of the study

-Part A only:

-Have fasting plasma glucose (PG) levels ≥7 millimoles per liter (mmol/L) (≥126 milligrams per deciliter (mg/dL)) at screening

-Have Hemoglobin A1c (HbA1c) level ≥ 6.5% (48 millimoles per mole (mmol/mol)) at screening

-Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >20% and 10%, above the upper limit of normal (ULN), respectively. Elevation of total bilirubin level is considered acceptable in case of Gilbert's disease (with a normal direct bilirubin)

-Part B only:

-Have Type 1 Diabetes or latent autoimmune diabetes in adults

-Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening

-Have known proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy

-Present comorbid conditions commonly associated with diabetes (for example, hypertension, hypercholesterolemia, hypothyroidism) unless they are well-controlled with stable medication

-Have had an episode of severe hypoglycaemia within 6 months prior to screening, or have a history of hypoglycaemia unawareness or poor recognition of hypoglycaemia

-Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase >2 × ULN at screening

-Have a resting heart rate of <50 or >100 beats per minute

-Have an estimated glomerular filtration rate (<60 milliliter/minute (mL/min)/1.73 m2, or a level of estimated glomerular filtration rate that would contraindicate the use of metformin per the label in the respective country

-Have a screening calcitonin ≥20.0 picograms per milliliter (pg/mL)

-Fasting serum triglyceride level of >500 mg/dL at screening

-Have serum AST or ALT >3 × ULN or TBL >1.5 × ULN (except for participants diagnosed with Gilbert's syndrome)

-Have taken any prescription medication that are specifically indicated for lowering serum triglycerides within the last 3 months

-Have taken within the last 3 months any medications that interfere with absorption of dietary cholesterol or fats

-Use of medications known to prolong the QT/QTc interval

-Treated only with diet and exercise at study entry

Endpoints (2)

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.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame:Baseline through Day 42

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3457263

Time frame:Day 1 through Day 42

AUC₀-∞

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.