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CompletedPhase 1

A Study of Multiple Doses of LY3305677 in Healthy Participants

A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677 in Healthy Subjects

Asset

Mazdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

Enrollment

56

actual

Study population

Healthy volunteers

Key I/E criterion

Healthy volunteers

Primary endpoint

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 IDNCT03325387
Org study ID16619
Secondary IDI8P-MC-OXABEli Lilly and Company

Timeline

Milestones

Study start2017-10-27actual
Study first posted2017-10-30actual
Primary completion2018-08-03actual
Study completion2018-08-03actual
Last update posted2018-08-16actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age20 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Are overtly healthy males or females, as determined by medical history and physical examination
Women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause
Are first-generation Japanese or non-Japanese. First-generation Japanese is defined as the participant, the participant's biological parents, and all of the participant's grandparents are of exclusive Japanese descent and have been born in Japan
Have a body weight of more than 54 kilograms (kg)

Exclusion criteria

Currently enrolled in a clinical study or have participated in a study within the past 3 months
Have an abnormality in the 12-lead electrocardiogram (ECG) at screening
Have history of pancreatitis
Have known or ongoing psychiatric disorders
Have undergone bariatric surgery or have used any drugs for weight loss
Have a history of alcoholism
Currently smoke more than 10 cigarettes a day

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.

Safety / tolerability / PK

3 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 115 days

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3305677

Time frame:Days 1 and 29: Predose through 168 hours post dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3305677

Time frame:Days 1 and 29: Predose through 168 hours post dose

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.