← Trials/Trial dossier/NCT03928379

CompletedPhase 1

A Study of LY3305677 in Participants With Type 2 Diabetes

A Multiple-Ascending Dose Study in Patients With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677

Asset

Mazdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

Enrollment

24

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

BMI 25-40

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 IDNCT03928379
Org study ID17011
Secondary ID2018-004779-11
Secondary IDI8P-MC-OXADEli Lilly and Company

Timeline

Milestones

Study first posted2019-04-26actual
Study start2019-10-27actual
Primary completion2021-07-08actual
Study completion2021-07-08actual
Last update posted2021-07-19actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years
Maximum age69 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Have Type II diabetes
Body mass index (BMI) of 25-40 kilograms per square meter (kg/m²), inclusive
Have a body weight of <150 kilograms (kg)
Have clinical lab test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator; however, should have serum magnesium and potassium levels, along with lactate dehydrogenase, CK values within the normal range at screening and Day -2.

Exclusion criteria

Have Type 1 diabetes or latent autoimmune diabetes in adults
Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization for 6 months prior to screening
Have had an episode of severe hypoglycemia, defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, within 6 months prior to Visit 1
Have an abnormal 12-lead electrocardiogram (ECG) at screening and/or Day -2 that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis
Have poorly controlled hypertension at screening; or a change in antihypertensive medication within 30 days of screening
Have an estimated glomerular filtration rate <45 milliliters per minute per 1.73 meters squared of body surface area (mL/min/1.73 m²)

Endpoints (5)

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

Safety / tolerability / PK
3
Glycemic / diabetes
2

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose

Time frame:Baseline, through Week 16

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

PD: Change from Baseline in Fasting Plasma Insulin

Time frame:Baseline, through Week 16

change from baseline, improvement

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

Time frame:Baseline through 24 weeks

Serious AEs (any)

event count, event

Secondary/protocol endpoint

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

Time frame:Baseline through 48 hours postdose

Cmax

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Baseline through 48 hours 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.