DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT05582096

CompletedPhase 1

A Study of LY3457263 in Obese Participants

A Dose-Escalation Treatment, Phase 1, Investigator- and Participant-Blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of LY3457263 in Combination With Tirzepatide in Overweight or Obese Participants

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

—

Enrollment

38

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI 27-45•Healthy volunteers

Primary endpoint

•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))

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 IDNCT05582096
Org study ID18463
Secondary IDJ1R-MC-GZFCEli Lilly and Company

Timeline

Milestones

Study first posted2022-10-17actual
Study start2022-11-11actual
Primary completion2023-06-08actual
Study completion2023-06-08actual
Last update posted2023-07-18actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age20 Years
Maximum age70 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Participants who are overtly healthy as determined by medical evaluation
•Have a stable body weight and body mass index (BMI) within the range 27.0 to 45.0 kilograms per meter squared (kg/m²)
•Male or female participants not of childbearing potential

Exclusion criteria

•Have a mean sitting systolic blood pressure (BP) higher than 160 millimeters of mercury (mmHg) or a mean sitting diastolic BP higher than 90 mmHg from 3 measurements
•Have an abnormal 12-lead electrocardiogram (ECG) at screening
•Have type 1 or type 2 diabetes mellitus

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 Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame:Baseline up to 11 weeks

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3457263

Time frame:Predose on Day 1 up to 43 days postdose

AUC₀–∞

concentration, descriptive

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.