DelfaGLP-1 Atlas

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CompletedPhase 1

A Study of LY3305677 in Healthy Participants

A First-in-Human, Single 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

66

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 IDNCT02972645
Org study ID16350
Secondary IDI8P-MC-OXAAEli Lilly and Company

Timeline

Milestones

Study first posted2016-11-23estimated
Study start2016-12-05actual
Primary completion2017-07-14actual
Study completion2017-07-14actual
Last update posted2017-07-24actual

Assets

Investigational agents

Mazdutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age20 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Overtly healthy as determined by medical history and physical examination
•Male participants: will agree to use a reliable method of birth control and will not donate sperm during the study and for at least 3 months following the last dose of the investigational product
•Female participants: women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause
•First generation Japanese participants or non-Japanese participants
•Have a body weight of more than 50 kilograms (kg)

Exclusion criteria

•Have participated within the last 3 months in a clinical trial involving an investigational product
•Have known allergies to glucagon-like peptide-1 (GLP-1) analogs, or any components of the formulation, or history of significant atopy
•Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or Day -1
•Have undergone any form of bariatric surgery
•Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
•Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase
•Show evidence of human immunodeficiency virus (HIV) or Hepatitis B or C
•Have used or intend to use medications that promote weight loss
•Have donated blood of more than 500 milliliter (mL) within the last month
•Currently smoke more than 10 cigarettes per 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 to Study Completion (approximately 16 weeks)

Serious AEs (any)

event count, event

Secondary/protocol endpoint

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

Time frame:Day 1 Pre-dose through Day 85

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Day 1 Pre-dose through Day 85

Cmax

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.