GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT02020616

TerminatedPhase 1, PHASE2Results posted

A Study of the Safety and Effectiveness of LY3053102 in Participants With Type 2 Diabetes

Safety, Tolerability, Pharmacokinetics, and Efficacy of LY3053102 With 12 Weeks of Treatment in Patients With Type 2 Diabetes Mellitus

Lead sponsor

Eli Lilly and Company

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 23-45•HbA1c 7-10.5%

Primary endpoint

•HbA1c, change

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 IDNCT02020616

Org study ID14515

Secondary IDI6I-MC-LMRBEli Lilly and Company

Timeline

Milestones

Study first posted2013-12-25estimated

Results first posted2017-12-20actual

Last update posted2019-10-08actual

Study start2013-12 (month precision)

Primary completion2015-02actual (month precision)

Study completion2015-02actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age21 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participants with type 2 diabetes mellitus for at least 6 months before entering the trial based on the disease diagnostic criteria (World Health Organization [WHO]) classification managed with diet or exercise alone or with a stable dose of metformin of at least 1000 mg/day for at least 60 days before screening or on metformin and an eligible second oral anti-hyperglycemic medication after a 60-day washout of the second oral anti-hyperglycemic medication

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

•Have a hemoglobin A1c value of ≥7.0% and ≤10.5%, if on diet and exercise or diet, exercise, and metformin (stable dose of at least 1000 mg/day for at least 60 days), or have a hemoglobin A1c value of ≥7.0% and ≤9.5%, and are on an appropriate diet and exercise regimen, a stable dose of metformin and willing to discontinue a second oral anti-hyperglycemic medication

•Have a body mass index ≥23 and ≤45 kilograms per square meter (kg/m^2)

Exclusion criteria

•Have used insulin for diabetic control for more than 6 consecutive days within 1 year prior to screening

•Have used thiazolidinediones within 3 months, or any other drugs for treatment of hyperglycemia (except metformin) within 2 months, prior to the first week of the study

•Have hepatitis B and/or positive hepatitis B surface antigen. hepatitis C or human immunodeficiency virus (HIV) and/or positive HIV antibodies

•Have known or suspected cardiac autonomic neuropathy (for example, resting tachycardia or orthostatic hypotension), based on clinical signs, symptoms, or appropriate diagnostic testing

•Have cardiac disease with functional status that is New York Heart Association Class II, III, or IV or in the last 6 months have had any of the following: a history of myocardial infarction , unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, or cerebrovascular accident (for example, stroke)

•Have poorly controlled hypertension, malignant hypertension, renal artery stenosis, and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days prior to the first week of the study

•Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or an alanine transaminase or aspartate aminotransferase levels >2 times the upper limit of the reference range

•Have evidence of hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid-stimulating hormone which, in the opinion of the investigator, would pose a risk to participant safety. Participants on a stable dose of thyroid replacement therapy may be eligible if they meet the other criteria

•Have clinically significant peripheral vascular disease, or clinical evidence of active diabetic proliferative retinopathy, (known significant autonomic neuropathy) as evidenced by urinary retention, orthostatic hypotension, diabetic diarrhea or gastroparesis

•Have an active or untreated malignancy or have been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years

•Have impaired renal function

•Have fasting triglycerides >500 milligrams per deciliter (mg/dL) at screening

•Have experienced a keto-acidotic episode requiring hospitalization in the last 6 months

•Have an electrocardiogram (ECG) considered to be indicative of cardiac disease

•Have personal or family history of long QT syndrome, family history of sudden death in a first-degree relative before age 40, or personal history of unexplained syncope within the last year. Use of prescription or over-the-counter medications known to prolong the QT or QTc interval

•Have a history of bone disease (including osteoporosis or unhealed fractures), evidence of osteoporosis (femoral neck or lumbar spine T-score <-2.5) determined by dual X-ray absorptometry (DXA) scan at screening, evidence of osteopenia (T-score between -1.0 and -2.5 at the femoral neck or lumbar spine) with a high risk of fracture based on risk factors or current active treatment of periodontal disease

Endpoints (12)

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

Glycemic / diabetes

Safety / tolerability / PK

Cardiometabolic biomarkers

Other clinical outcomes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Body Weight at 12-Week Endpoint

Time frame:Baseline, Week 12

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram (kg)	95% CI
Placebo	0.7	—
7 mg LY3053102	1.5	—
15 mg LY3053102	0.0	—
50 mg LY3053102	0.4	—
100 mg LY3053102	-1.7	—
200 mg LY3053102	-2.0	—
2 mg Exenatide ER	-0.1	—

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint

Time frame:Baseline, Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percent of HbA1c	95% CI
Placebo	-0.49	—
7 mg LY3053102	-0.70	—
15 mg LY3053102	-0.75	—
50 mg LY3053102	-0.22	—
100 mg LY3053102	-0.48	—
200 mg LY3053102	-0.52	—
2 mg Exenatide ER	-1.43	—

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint

Time frame:Week 12

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of Participants	95% CI
PlaceboHbA1c <7.0%	0.0	—
HbA1c ≤6.5%	0.0	—
7 mg LY3053102HbA1c <7.0%	14.3	—
HbA1c ≤6.5%	0.0	—
15 mg LY3053102HbA1c <7.0%	40.0	—
HbA1c ≤6.5%	0.0	—
50 mg LY3053102HbA1c <7.0%	20.0	—
HbA1c ≤6.5%	0.0	—
100 mg LY3053102HbA1c <7.0%	0.0	—
HbA1c ≤6.5%	0.0	—
200 mg LY3053102HbA1c <7.0%	0.0	—
HbA1c ≤6.5%	0.0	—
2 mg Exenatide ERHbA1c <7.0%	83.3	—
HbA1c ≤6.5%	66.7	—

Secondary/protocol endpoint

Percentage of Participants That Require Rescue Therapy

Time frame:Baseline through Week 12

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of Participants	95% CI
Placebo	0.0	—
7 mg LY3053102	0.0	—
15 mg LY3053102	12.5	—
50 mg LY3053102	14.3	—
100 mg LY3053102	0.0	—
200 mg LY3053102	0.0	—
2 mg Exenatide ER	0.0	—

Secondary/protocol endpoint

Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milligram/deciliter (mg/dL)	95% CI
PlaceboMorning Meal (Post- minus Pre-prandial)	-23.4	—
Midday Meal (Post- minus Pre-prandial)	-1.1	—
Evening Meal (Post- minus Pre-prandial)	-18.8	—
Bedtime	3.9	—
7 mg LY3053102Morning Meal (Post- minus Pre-prandial)	-18.7	—
Midday Meal (Post- minus Pre-prandial)	-31.3	—
Evening Meal (Post- minus Pre-prandial)	-11.1	—
Bedtime	18.8	—
15 mg LY3053102Morning Meal (Post- minus Pre-prandial)	-57.7	—
Midday Meal (Post- minus Pre-prandial)	-55.0	—
Evening Meal (Post- minus Pre-prandial)	-46.5	—
Bedtime	-44.5	—
50 mg LY3053102Morning Meal (Post- minus Pre-prandial)	-34.9	—
Midday Meal (Post- minus Pre-prandial)	-24.7	—
Evening Meal (Post- minus Pre-prandial)	-25.9	—
Bedtime	-10.1	—
100 mg LY3053102Morning Meal (Post- minus Pre-prandial)	4.7	—
Midday Meal (Post- minus Pre-prandial)	2.5	—
Evening Meal (Post- minus Pre-prandial)	-39.0	—
Bedtime	4.9	—
200 mg LY3053102Morning Meal (Post- minus Pre-prandial)	-26.8	—
Midday Meal (Post- minus Pre-prandial)	-24.6	—
Evening Meal (Post- minus Pre-prandial)	-61.3	—
Bedtime	-13.0	—
2 mg Exenatide ERMorning Meal (Post- minus Pre-prandial)	-47.9	—
Midday Meal (Post- minus Pre-prandial)	-31.3	—
Evening Meal (Post- minus Pre-prandial)	-4.9	—
Bedtime	-53.6	—

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Lipids at 12-Week Endpoint

Time frame:Baseline, Week 12

change from baseline, improvement

componentsHDL-C, change, LDL-C, change, Triglycerides, change, Total cholesterol, change

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
PlaceboHDL-C	1.0	—
LDL-C	12.1	—
7 mg LY3053102HDL-C	6.0	—
LDL-C	6.8	—
15 mg LY3053102HDL-C	9.3	—
LDL-C	-25.6	—
50 mg LY3053102HDL-C	6.4	—
LDL-C	-6.5	—
100 mg LY3053102HDL-C	6.0	—
LDL-C	-2.2	—
200 mg LY3053102HDL-C	11.4	—
LDL-C	-7.3	—
2 mg Exenatide ERHDL-C	-2.3	—
LDL-C	-19.9	—

Secondary/protocol endpoint

Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP])

Time frame:Baseline, Week 12

bone formation markers

change from baseline, descriptive

Posted result

Group	Value (least_squares_mean), microgram/liter (ug/L)	95% CI
PlaceboOsteocalcin	1.2	—
Bone-Specific ALP	0.4	—
7 mg LY3053102Osteocalcin	-0.7	—
Bone-Specific ALP	-0.1	—
15 mg LY3053102Osteocalcin	-1.7	—
Bone-Specific ALP	-0.2	—
50 mg LY3053102Osteocalcin	0.0	—
Bone-Specific ALP	-1.9	—
100 mg LY3053102Osteocalcin	-2.6	—
Bone-Specific ALP	-1.9	—
200 mg LY3053102Osteocalcin	-0.2	—
Bone-Specific ALP	-0.3	—
2 mg Exenatide EROsteocalcin	0.3	—
Bone-Specific ALP	-2.3	—

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Percentage of Participants With Anti-Drug Antibodies to LY3053102

Time frame:Baseline through Study Completion (Up to 6 Months)

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (number), Percentage of Participants	95% CI
Placebo	0	—
7 mg LY3053102	1	—
15 mg LY3053102	1	—
50 mg LY3053102	0	—
100 mg LY3053102	2	—
200 mg LY3053102	2	—
2 mg Exenatide ER	2	—

Secondary/protocol endpoint

Percentage of Participants With Hypoglycemia

Time frame:Baseline through Week 12

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), Percentage of Participants	95% CI
Placebo	10.0	—
7 mg LY3053102	12.5	—
15 mg LY3053102	0.0	—
50 mg LY3053102	0.0	—
100 mg LY3053102	12.5	—
200 mg LY3053102	12.5	—
2 mg Exenatide ER	20.0	—

Secondary/protocol endpoint

Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC [τ,ss]) of LY3053102

Time frame:Predose, 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 hours post-dose

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), microgram•hour/milliliter (µg•h/mL)	95% CI
7 mg LY3053102	22.6	—
15 mg LY3053102	76.8	—
50 mg LY3053102	190.0	—
100 mg LY3053102	350.0	—
200 mg LY3053102	917.0	—

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint/low confidence

Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP])

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), nanogram/milliliter (ng/mL)	95% CI
PlaceboBeta-Crosslaps	-0.038	—
P1NP	5.0	—
7 mg LY3053102Beta-Crosslaps	-0.033	—
P1NP	-0.3	—
15 mg LY3053102Beta-Crosslaps	-0.023	—
P1NP	0.9	—
50 mg LY3053102Beta-Crosslaps	0.001	—
P1NP	1.9	—
100 mg LY3053102Beta-Crosslaps	0.004	—
P1NP	-6.8	—
200 mg LY3053102Beta-Crosslaps	0.031	—
P1NP	-0.2	—
2 mg Exenatide ERBeta-Crosslaps	-0.010	—
P1NP	2.3	—

Secondary/protocol endpoint/low confidence

Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milligram/square centimeter (mg/cm2)	95% CI
PlaceboL1-L4 Intervertebral Space	1.4	—
Neck of Femur	0.2	—
Total Hip	0.2	—
7 mg LY3053102L1-L4 Intervertebral Space	-0.4	—
Neck of Femur	-0.6	—
Total Hip	-0.6	—
15 mg LY3053102L1-L4 Intervertebral Space	1.2	—
Neck of Femur	-0.4	—
Total Hip	-0.7	—
50 mg LY3053102L1-L4 Intervertebral Space	1.0	—
Neck of Femur	-0.8	—
Total Hip	-1.0	—
100 mg LY3053102L1-L4 Intervertebral Space	2.0	—
Neck of Femur	-0.3	—
Total Hip	0.1	—
200 mg LY3053102L1-L4 Intervertebral Space	1.6	—
Neck of Femur	-1.2	—
Total Hip	-0.7	—
2 mg Exenatide ERL1-L4 Intervertebral Space	1.8	—
Neck of Femur	-2.1	—
Total Hip	-1.0	—

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.