GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1, PHASE2Results posted

A Study to Examine the Pharmacokinetics, Tolerability, Safety and Efficacy of Exenatide Once Weekly Suspension

A Two-Cohort, Single- and Repeat Dose Study to Examine the Pharmacokinetics, Tolerability, and Safety of Ready to Use Exenatide Once Weekly in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Type 2 diabetes

Key I/E criteria

•BMI 23-35•HbA1c 7.1-10%

Primary endpoints

•Area Under the Curve (AUC) for Single Dose of 10 mg Exenatide (Cohort 1)•Cmax for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants•Cmax (Tmax) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy

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 IDNCT00894322

Org study IDBCB110

Timeline

Milestones

Study first posted2009-05-07estimated

Results first posted2014-05-14estimated

Last update posted2015-09-18estimated

Study start2009-04 (month precision)

Primary completion2009-08actual (month precision)

Study completion2009-08actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Healthy volunteersType 2 diabetes

Eligibility

Who can enroll

Minimum age19 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Cohort 1:

•Is 19 to 65 years old

•Has a body mass index (BMI) of 23 kg/m2 to 35 kg/m2, inclusive, at study start

Cohort 2:

•Is 19 to 75 years old

•Has been diagnosed with type 2 diabetes mellitus

•Has HbA1c of 7.1% to 10.0%, inclusive, at study start

•Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at study start

•Has been treated with diet and exercise alone or with a stable regimen of metformin, a TZD, or a combination of metformin and a TZD, for a minimum of 2 months prior to study start

•Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:

–Hormone replacement therapy (female subjects)

–Oral contraceptives (female subjects)

–Antihypertensive agents

–Lipid-lowering agents

–Thyroid replacement therapy

–Antidepressant agents

Exclusion criteria

Cohort 1:

•Has a personal history of diabetes mellitus (including impaired glucose tolerance, impaired fasting glucose, or gestational diabetes)

•Has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start

•Has ever been exposed to exenatide (BYETTA, exenatide once weekly, or any other formulation of exenatide) or any GLP 1 analog

Cohort 2:

•Has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start

•Has ever been exposed to exenatide (BYETTA, exenatide once weekly, or any other formulation of exenatide) or any GLP 1 analog

•Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:

–Any DPP-4 inhibitor or sulfonylurea (SU) within 3 months prior to study start

–Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days prior to study start

–Insulin within 2 weeks prior to study start or for more than 1 week within 3 months prior to study start

–Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption

–Prescription or over-the-counter weight loss medications within 3 months prior to study start

Endpoints (19)

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

Cardiometabolic biomarkers

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Mean Change From Baseline at Week 12 in Body Weight in Participants With Diabetes (Cohort 2) in the ITT Population

Time frame:Baseline, Week 12

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Cohort 2 Exenatide 2 mg	-1.41	—
Cohort 2 Placebo	-0.39	—

LS Mean Difference-1.0395% CI-2.73 – 0.68p0.2285ANOVA

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Least Square Mean Change From Baseline in Hemoglobin A1c (HbA1c) to Week 12 in Participants With Diabetes (Cohort 2) in the ITT Population

Time frame:Day 1 to Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percent of hemoglobin	95% CI
Cohort 2 Exenatide 2 mg	-0.87	—
Cohort 2 Placebo	0.08	—

Mean Difference (Final Values)-0.9595% CI-1.50 – -0.40p0.0013ANOVA

Secondary/protocol endpoint

Number of Participants Achieving HbA1c Less Than Equal to (<=) 6.5% and Less Than (<) 7% at Week 12 in Participants With Diabetes (Cohort 2) in the ITT Population

Time frame:Week 12

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), participants	95% CI
Cohort 2 Exenatide 2 mgBaseline HbA1c >= 7%	22	—
Week 12 HbA1c <= 6.5%	9	—
Week 12 HbA1c <7%	14	—
Cohort 2 PlaceboBaseline HbA1c >= 7%	12	—
Week 12 HbA1c <= 6.5%	1	—
Week 12 HbA1c <7%	2	—

p0.0033Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Mean Change From Baseline at Week 12 in Fasting Plasma Glucose in Participants With Diabetes (Cohort 2) for the ITT Population

Time frame:Baseline, Week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Cohort 2 Exenatide 2 mg	-32	—
Cohort 2 Placebo	8	—

LS Mean Difference-40.495% CI-66.5 – -14.3p0.0035ANOVA

Cardiometabolic biomarkers

2 endpoints

Primary/protocol endpoint

Mean Change From Baseline to End of Study in Sitting Diastolic and Systolic Blood Pressure in Cohorts 1 and 2 in ITT Population

Time frame:Day 1 to Week 12

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), mmHg	95% CI
Cohort 1 Exenatide 10 mgDiastolic Blood Pressure	6.2	—
Systolic Blood Pressure	-1.4	—
Cohort 2 Exenatide 2 mgDiastolic Blood Pressure	4.6	—
Systolic Blood Pressure	-8.4	—
Cohort 2 PlaceboDiastolic Blood Pressure	6.8	—
Systolic Blood Pressure	-1.7	—

Primary/protocol endpoint

Mean Change From Baseline to End of Study in Sitting Heart Rate in Cohorts 1 and 2 in ITT Population

Time frame:Day 1 to Week 12

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), bpm	95% CI
Cohort 1 Exenatide 10 mg	-7.5	—
Cohort 2 Exenatide 2 mg	-5.4	—
Cohort 2 Placebo	-9.1	—

Safety / tolerability / PK

13 endpoints

Primary/protocol endpoint

Area Under the Curve (AUC) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population

Time frame:Day 1, Week 12

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), pg*h/mL	95% CI
Cohort 1 Exenatide 10 mgAUC (0-8h), n=30	125.6	—
AUC (0-Week 12), n=30	147220.2	—

Primary/protocol endpoint

Maximum Concentration (Cmax) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population

Time frame:Day 1, Week 12

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_mean), pg/mL	95% CI
Cohort 1 Exenatide 10 mgCmax 0 hour to 8 hours	34.9	—
Cmax 0 hour to Week 12	331.2	—

Primary/protocol endpoint

Time to Maximum Concentration (Tmax) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population

Time frame:Day 1, Week 12

Tmax

descriptive

Posted result

Group	Value (geometric_mean), hours	95% CI
Cohort 1 Exenatide 10 mgTmax (0 to 8 hours), n=27	7.0	—
Tmax (0 hour to Week 12), n=30	998.1	—

Primary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Injection Site TEAEs, Serious Adverse Events (SAEs), Deaths, and Withdrawals Due to AEs in Cohort 1 and Cohort 2 in Intent to Treat (ITT) Population

Time frame:Day 1 to Week12

Treatment-emergent AEs (any)

descriptive

componentsTreatment-emergent AEs (any), Serious AEs (any), Death (safety endpoint), Discontinuation due to AE

Posted result

Group	Value (number), participants	95% CI
Cohort 1 Exenatide 10 mgTEAE	26	—
Injection Site TEAEs	16	—
Withdrawal due to AE	0	—
SAE	0	—
Death	0	—
Cohort 2 Exenatide 2 mgTEAE	22	—
Injection Site TEAEs	18	—
Withdrawal due to AE	0	—
SAE	0	—
Death	0	—
Cohort 2 PlaceboTEAE	9	—
Injection Site TEAEs	7	—
Withdrawal due to AE	0	—
SAE	1	—
Death	0	—

Primary/protocol endpoint

Number of Participants With Concomitant Medications in Cohort 1 and Cohort 2 in ITT Population

Time frame:Day 1 to 12 weeks

descriptive

Posted result

Group	Value (number), participants	95% CI
Cohort 1 Exenatide 10 mg	30	—
Cohort 2 Exenatide 2 mg	21	—
Cohort 2 Placebo	11	—

Primary/protocol endpoint

Number of Participants With Hematology and Serum Chemistry Laboratory Values of Potential Clinical Importance in Cohorts 1 and 2 in ITT Population

Time frame:Day 1 to Week 12

threshold achievement, event

Posted result

Group	Value (number), participants	95% CI
Cohort 1 Exenatide 10 mgHematocrit low <36%	0	—
Platelets high <75 to >500*10^3/µ/L	0	—
Calcium high <8 to >11 mg/dL	0	—
CK high >3*ULN	1	—
G-GT high >3*ULN in U/L	0	—
Glucose low <50 to > 450 mg/dL	1	—
Lipase high >3*ULN in U/L	0	—
Uric Acid high >8.0 mg/dL	0	—
Cohort 2 Exenatide 2 mgHematocrit low <36%	0	—
Platelets high <75 to >500*10^3/µ/L	1	—
Calcium high <8 to >11 mg/dL	1	—
CK high >3*ULN	0	—
G-GT high >3*ULN in U/L	0	—
Glucose low <50 to > 450 mg/dL	0	—
Lipase high >3*ULN in U/L	0	—
Uric Acid high >8.0 mg/dL	1	—
Cohort 2 PlaceboHematocrit low <36%	1	—
Platelets high <75 to >500*10^3/µ/L	0	—
Calcium high <8 to >11 mg/dL	0	—
CK high >3*ULN	0	—
G-GT high >3*ULN in U/L	1	—
Glucose low <50 to > 450 mg/dL	0	—
Lipase high >3*ULN in U/L	1	—
Uric Acid high >8.0 mg/dL	0	—

Primary/protocol endpoint

Antibody Titers for Participants With Treatment Emergent Positive Antibodies to Exenatide in Participants Who Received Exenatide in Cohorts 1 and 2

Time frame:Day 1 to Week 12

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (geometric_mean), Reportable Titers	95% CI
Cohort 1 Exenatide 10 mgWeek 2, N=30, 23; n=4, 1	25.0	—
Week 4, N=30, 23; n=14, 10	394.6	—
Week 6, N=30, 23; n=0, 15	NA	—
Week 8, N=29, 23; n=22,15	300.7	—
Week 10, N=29, 23; n=0,15	NA	—
Last visit, N=30, 23; n=20, 15	202.6	—
Cohort 2 Exenatide 2 mgWeek 2, N=30, 23; n=4, 1	25.0	—
Week 4, N=30, 23; n=14, 10	202.6	—
Week 6, N=30, 23; n=0, 15	295.9	—
Week 8, N=29, 23; n=22,15	561.4	—
Week 10, N=29, 23; n=0,15	453.0	—
Last visit, N=30, 23; n=20, 15	625.0	—

Primary/protocol endpoint

Area Under the Curve (AUC) for 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population

Time frame:Week 10-11; Weeks 10 - 12

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), pg*hr/mL	95% CI
Cohort 2 Exenatide 2 mgAUC (0-6h) at Week 10, n=18	1535.3	—
AUC (0-168h) at Weeks 10-11, n=18	49100.2	—
AUC (0-tlast) at Weeks 10-12, n=17	101615.0	—

Primary/protocol endpoint

Average Exenatide Concentration (Cave) of 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population

Time frame:Week 10 - Week 11; Week 10 - Week 12

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Value (geometric_mean), pg/mL	95% CI
Cohort 2 Exenatide 2 mgCave at Weeks 10-11; n=18	292.7	—
Cave at Weeks 10-12; n=17	302.4	—

Primary/protocol endpoint

Maximum Concentration (Cmax) for 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population

Time frame:Week 10, Weeks 10-11, Weeks 10-12

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_mean), pg/mL	95% CI
Cohort 2 Exenatide 2 mgCmax at 0-6 h Week 10; n=18	304.9	—
Cmax at 0-168 h Weeks 10=11; n=18	362.6	—
Cmax at 0-tlast Weeks 10-12; n=17	410.5	—

Primary/protocol endpoint

Time to Maximum Concentration (Tmax) of 2 mg Exenatide (Cohort 2) in Participants With Diabetes in Pharmacokinetic Evaluable Population

Time frame:Week 10, Weeks 10-11, Weeks 10-12

Tmax

descriptive

Posted result

Group	Value (geometric_mean), hours	95% CI
Cohort 2 Exenatide 2 mgTmax 0-6 h Week; n=18	1.4	—
Tmax 0-168 h Weeks 10-11; n=18	34.3	—
Tmax 0-tlast Weeks 10-12; n=17	60.0	—

Secondary/protocol endpoint

AUC (0 Hour to 168 Hour) for 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population

Time frame:Day 1 to Week 1

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), pg*h/mL	95% CI
Cohort 1 Exenatide 10 mg	3269.6	—

Secondary/protocol endpoint

Average Exenatide Concentration (Cave) of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population

Time frame:Day 1 to Week 1

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Value (geometric_mean), pg/mL	95% CI
Cohort 1 Exenatide 10 mg	32.5	—

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.