GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1Results posted

A Study of LY3025876 in Participants With Diabetes

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of LY3025876 in Patients With Type 2 Diabetes Mellitus

Lead sponsor

Eli Lilly and Company

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criterion

•BMI ≥23

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 IDNCT01870297

Org study ID14347

Secondary IDI6D-MC-SMRBEli Lilly and Company

Timeline

Milestones

Study first posted2013-06-06estimated

Last update posted2019-01-24actual

Results first posted2019-01-24actual

Study start2013-06 (month precision)

Primary completion2014-12actual (month precision)

Study completion2014-12actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age21 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of type 2 diabetes mellitus (T2DM) as determined by the investigator, controlled with diet or exercise alone or on a stable dose of metformin for at least 30 days

•Have a body mass index (BMI) greater than or equal to 23 and less than or equal to 45 kilograms per square meter (kg/m^2) at screening

•Have a supine blood pressure reading at screening of between 90-160 millimeter of mercury (mmHg) (systolic) and 40-95 mmHg (diastolic)

•Women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause

Exclusion criteria

•Have taken LY3025876 or investigational drugs like it (for example, other fibroblast growth factor-21 [FGF21]-related drugs) or have known allergies to these drugs

•History or presence of bone disease (including osteoporosis or unhealed fractures)

•Current active treatment of periodontal disease

•Have had a significant change in weight, defined as a gain or loss of at least 4 kilogram (kg) (9 pounds) in the last 3 months

•Have had greater than 1 episode of severe hypoglycemia within 6 months of screening that required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions or had a seizure or coma

•Have known allergies or a history of intolerance to liraglutide, glucagon-like peptide 1 (GLP-1) analogues, or other related compounds

•Have a history of acute or chronic pancreatitis

•Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2

Endpoints (10)

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

Glycemic / diabetes

2 endpoints

Secondary/registry result

Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose

Time frame:Baseline, Day 28

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), milligram/deciliter (mg/dL)	95% CI
Placebo Part A	3.52	—
0.5 mg LY3025876	18.08	—
1.5 mg LY3025876	0.12	—
5.0 mg LY3025876	-14.50	—
15 mg LY3025876	22.96	—
Placebo Part B	11.72	—
5.0 mg LY3025876 + Liraglutide	6.32	—

Secondary/protocol endpoint

Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose

Time frame:Baseline, Day 28

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

8 endpoints

Primary/registry result

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:Predose on Day 1 up to Day 56 in each Part

Serious AEs (any)

event count, event

Posted result

Group	Value (number), participants	95% CI
Placebo Part A	0	—
0.5 mg LY3025876	0	—
1.5 mg LY3025876	0	—
5.0 mg LY3025876	0	—
15 mg LY3025876	0	—
Placebo + Liraglutide	0	—
5.0 mg LY3025876 + Liraglutide	0	—

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:Predose on Day 1 up to Day 56 in each Part

Serious AEs (any)

event count, event

Secondary/registry result

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876

Time frame:Predose and 0.5 hour(hr), 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogramshour/milliliter (nghr/mL)	95% CI
0.5 mg LY3025876	51.5	—
1.5 mg LY3025876	207	—
5.0 mg LY3025876	622	—
15 mg LY3025876	1930	—
LY3025876 + Liraglutide	525	—

Secondary/registry result

PK: Maximum Concentration (Cmax) of LY3025876

Time frame:Days 1 and 28: Predose and 0.5 hr, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogram/milliliter (ng/mL)	95% CI
0.5 mg LY3025876Day 1	3.90	—
Day 28	4.87	—
1.5 mg LY3025876Day 1	17.5	—
Day 28	14.2	—
5.0 mg LY3025876Day 1	45.1	—
Day 28	51.9	—
15 mg LY3025876Day 1	126	—
Day 28	185	—
5.0 mg LY3025876 + LiraglutideDay 1	40.3	—
Day 28	44.8	—

Secondary/registry result

Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies

Time frame:Predose on Day 7, 14, 28, 56, and 180

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo Part APositive Antibodies Day 7	0	—
Positive Antibodies Day 14	0	—
Positive Antibodies Day 28	0	—
Positive Antibodies Day 56	0	—
Positive Antibodies Day 180	0	—
0.5 mg LY3025876Positive Antibodies Day 7	0	—
Positive Antibodies Day 14	1	—
Positive Antibodies Day 28	1	—
Positive Antibodies Day 56	1	—
Positive Antibodies Day 180	0	—
1.5 mg LY3025876Positive Antibodies Day 7	0	—
Positive Antibodies Day 14	0	—
Positive Antibodies Day 28	2	—
Positive Antibodies Day 56	4	—
Positive Antibodies Day 180	0	—
5.0 mg LY3025876Positive Antibodies Day 7	0	—
Positive Antibodies Day 14	0	—
Positive Antibodies Day 28	2	—
Positive Antibodies Day 56	2	—
Positive Antibodies Day 180	1	—
15 mg LY3025876Positive Antibodies Day 7	1	—
Positive Antibodies Day 14	0	—
Positive Antibodies Day 28	6	—
Positive Antibodies Day 56	6	—
Positive Antibodies Day 180	4	—
Placebo + LiraglutidePositive Antibodies Day 7	0	—
Positive Antibodies Day 14	0	—
Positive Antibodies Day 28	0	—
Positive Antibodies Day 56	0	—
Positive Antibodies Day 180	0	—
5.0 mg LY3025876 + LiraglutidePositive Antibodies Day 7	1	—
Positive Antibodies Day 14	1	—
Positive Antibodies Day 28	1	—
Positive Antibodies Day 56	1	—
Positive Antibodies Day 180	0	—

Secondary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876

Time frame:Predose and 0.5 hour(hr), 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

PK: Maximum Concentration (Cmax) of LY3025876

Time frame:Days 1 and 28: Predose and 0.5 hr, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose

Cmax

concentration, descriptive

Secondary/protocol endpoint

Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies

Time frame:Predose on Day 7, 14, 28, 56, and 180

Immunogenicity (ADA)

threshold achievement, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.