DelfaGLP-1 Atlas

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CompletedPhase 1

A Study of LY3325656 in Healthy Participants and Participants With Type 2 Diabetes

A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3325656 After Single Dose in Healthy Subjects and Patients With Type 2 Diabetes

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

2

Recruiting sites

—

Enrollment

80

actual

Study population

Healthy volunteers, Type 2 diabetes

Key I/E criteria

•BMI ≥18.5•HbA1c ≥7%•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 IDNCT03115099
Org study ID16433
Secondary IDI8U-MC-DMBAEli Lilly and Company

Timeline

Milestones

Study first posted2017-04-14actual
Study start2017-05-31actual
Primary completion2018-04-05actual
Study completion2018-04-05actual
Last update posted2018-08-23actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Healthy volunteersType 2 diabetes

Eligibility

Who can enroll

Minimum age21 Years
Maximum age70 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

For all participants:

•Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
•Have a screening body mass index (BMI) of at least 18.5 kilograms per square meter (kg/m²)
•Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study

For participants with Type 2 Diabetes Mellitus:

•Have diabetes controlled on diet and exercise with or without metformin for at least 30 days prior to screening, or on sulfonylureas with or without metformin
•Have a glycated hemoglobin (HbA1c) value of greater than or equal to 7% and less than or equal to 11% at screening (exercise with or without metformin)
•Have a HbA1c value of greater than or equal to 7% and less than or equal to 8.5% at screening (sulfonylureas with or without metformin)

Exclusion criteria

For all participants:

•Are currently participating in another clinical study or completed one in the last 30 days
•Are allergic to LY3325656 or other related drugs
•Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
•Have electrocardiogram (ECG) readings that are not suitable for the study
•Are infected with hepatitis B
•Are infected with human immunodeficiency virus (HIV)
•Have donated more than 450 mL of blood in the last 3 months or if have donated any blood in the last month
•Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
•Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic

For participants with Type 2 Diabetes Mellitus:

•Have had heart disease or stroke within 6 months before entering the study
•Have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment as determined by the study doctor
•Have been hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
•Have used insulin to control diabetes in the last 6 months
•Show symptoms of high blood sugar e.g. frequent urination, always feeling thirsty, or unexpected weight loss

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 approximately 12 weeks and 5 weeks after first administration of study drug in Parts A and B, respectively

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3325656

Time frame:Baseline up to 72 hours after each dose of study drug

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics: Maximum Concentration (Cmax) of LY3325656

Time frame:Baseline up to 72 hours after each dose of study drug

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.