GLP-1 Peptide Atlas, by Delfa

WithdrawnPhase 1

Study of Exenatide Once-Weekly Suspension in Chinese Patients With Type 2 Diabetes Mellitus

A Phase 1, Open-Label Study to Evaluate Single and Multiple Dose Pharmacokinetics, Safety, and Tolerability of Exenatide Once-Weekly Suspension in Chinese Patients With Type 2 Diabetes Mellitus

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

—

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 18.5-35•HbA1c ≤10.5%

Primary endpoints

•Plasma concentration (steady state)•Cmax•Tmax

Identifiers

Registered as

NCT IDNCT04001231

Org study IDD5553C00008

Timeline

Milestones

Study first posted2019-06-28actual

Last update posted2020-06-04actual

Study start2020-06-30estimated

Primary completion2021-07-02estimated

Study completion2021-07-02estimated

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Provision of informed consent prior to any study-specific procedures.

2. Male or female patients with T2DM treated with diet modification and exercise alone or in combination with a stable (in PI's opinion) regimen of metformin only for at least two months prior to screening. The T2DM diagnosis will be confirmed clinically by the PI, and should be consistent with the World Health Organization criteria for diagnosis and classification of diabetes

3. Between 20 to 75 years of age inclusive at Visit 1 (Screening)

4. The following criterion applies to females of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopause) only:

1. Test negative for pregnancy at the time of screening.

2. Intend not to become pregnant during the study.

3. Are sexually inactive or have practiced a reliable method of birth control (for example, use of oral contraceptives or levonorgestrel, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, intrauterine devices, partner with vasectomy) for at least 6 weeks prior to screening.

4. Agree to continue to use a reliable method of birth control (as determined by the PI) during the study and until 90 days after last dose.

5. Have a body weight of ≥45 kg and a body mass index (BMI) of 18.5 to 35 kg/m2 inclusive at Visit 1 (Screening).

6. Have clinical laboratory test results within the normal reference range for the population or study site, or with abnormalities deemed clinically insignificant by the PI. Abnormalities of plasma glucose (fasting ≤12.0 mmol/L and anytime≤15.0mmol/L), HbA1c (<10.5%), plasma lipids (TG<5.7 mmol/L), and urinary protein (with a range of trace < 2+ on dipstick) are acceptable.

7. Venous access sufficient to allow blood sampling as per the protocol.

8. Are reliable and willing to be available for the duration of the study and are willing to follow study procedures.

Exclusion criteria

1. Involvement in the planning and/or conduct of the study (applies to bothAstraZeneca staff and/or staff at the study site, and direct family members).

2. Previous enrollment in the present study or have previously completed or withdrawn from any other study investigating exenatide.

3. Within 30 days of the initial dose of IP, have received treatment with a drug that has not received regulatory approval for any indication.

4. Known allergy or hypersensitivity to exenatide or any of the excipients contained in these agents (exenatide: sodium acetate buffer, mannitol, metacresol, MCT vehicle).

5. Previous treatment with exenatide or related GLP-1 receptor agonist compounds.

6. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.

7. Systolic blood pressure (SBP) persistently (on ≥2 separate occasions) >160 mmHg on stable regimen of antihypertensive medication or >180 mmHg regardless of antihypertensive treatment.

8. History of, or currently have angina, revascularization, myocardial infarction, or heart failure.

9. Clinically significant peripheral vascular disease.

10. Evidence of poorly controlled T2DM or evidence of significant diabetes-related complications such as:

1. Plasma glucose >12 mmol/L (fasting) or >15 mmol/L (anytime) at Visit 1 (Screening)

2. HbA1c >10.5%

3. History of hypoglycemic or hyperglycemic coma within 1 year prior to Visit 1 (Screening)

4. History of active diabetic proliferative retinopathy or macular oedema

5. Known significant autonomic neuropathy as evidenced by urinary retention, orthostatic hypotension, diabetic diarrhea, or gastroparesis

11. Two or more episodes of major hypoglycemia within 6 months prior to Visit 1 (Screening). See Section 5.2.8.1 for hypoglycemia classification.

12. Impaired renal function (serum creatinine >125 μ/mol/L in women, >132 μ/mol/L in men).

13. Liver disease, acute or chronic hepatitis, alanine aminotransferase (ALT/SGPT), or aspartate aminotransferase (AST) ≥3x upper limit of normal (ULN) of the reference range and total bilirubin level (TBL) ≥2xULN.

14. Evidence of hepatitis B and/or positive hepatitis B surface antigen.

15. Clinical symptoms associated with cholelithiasis (eg, cholecystitis or biliary colic), within 3 years of Visit 1 (Screening).

16. History of, or currently have acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL at Visit 1 (Screening).

17. Have a serum calcitonin concentration ≥40 pg/mL at Visit 1 (Screening).

18. An abnormality in the 12-lead ECG that, in the opinion of the PI, increases the risks associated with participating in the study.

19. Evidence of significant active neuropsychiatric disease.

20. Evidence of current use of drugs of abuse or history of use within the past year.

21. Women who are lactating and/or breastfeeding.

22. Use of over-the-counter or prescription medication (other than thyroid replacement therapy, metformin, antihypertensive medication, lipid-lowering agents, aspirin, or paracetamol/acetaminophen) 7 and 14 days, respectively prior to dosing. If this situation arises, inclusion of an otherwise suitable patient may occur if permitted by the PI and Sponsor.

23. Significant active hematological disease and/or blood donation of more than 400 mL within the last 6 months.

24. An average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or patients unwilling to adhere to study alcohol restrictions (1 unit=360 mL of beer; 150 mL of wine; 45 mL of distilled spirits).

25. A personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B.

26. Currently enrolled in any other clinical study.

27. Determined by the PI to be unsuitable for inclusion in this study.

Endpoints (25)

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

Cardiometabolic biomarkers

Glycemic / diabetes

1 endpoint

Other/protocol endpoint

HbA1c

Time frame:Blood sample will be collected at Visit1 (screening), Visit3 (Day1, pre-dose), Visit7 (Week 3, pre-dose), V10 (Week6, pre-dose), Visit13 (Week9, pre-dose), Visit16 (Week12, pre-dose), Visit21 (Week14, Day7, post-dose) and Visit29 (Week 26, follow-up)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Blood pressure (BP)

Time frame:Blood pressure will be collected at Visit 1, Visit 3 (pre-dose, 2- and 24-hours post-dose), Visit 4 (post-dose), Visit 5 (post-dose), Visit 6-17 (pre-dose), Visit 18 (pre-dose, 2- and 24-hours post-dose), Visit 19-21 (post-dose), Visit 22-29

descriptive

Secondary/protocol endpoint

Pulse rate

Time frame:Pulse rate will be collected at Visit 1, Visit 3 (pre-dose, 2- and 24-hours post-dose), Visit 4 (post-dose), Visit 5 (post-dose), Visit 6-17 (pre-dose), Visit 18 (pre-dose, 2- and 24-hours post-dose), Visit 19-21 (post-dose), Visit 22-29

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

22 endpoints

Primary/protocol endpoint

Plasma concentrations versus time profile of exenatide

Time frame:Blood sample will be collected on Visit 3-6 (pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8, 24, 72, 120, 168 hours post-dose). Visit 7-17 (pre-dose). Visit 18-22 (pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8, 24, 72, 120, 168 hours post-dose). Visit 23-29 (once/visit).

Plasma concentration (steady state)

concentration, descriptive

Primary/protocol endpoint

Cmax

concentration, descriptive

Primary/protocol endpoint

tmax

Tmax

concentration, descriptive

Primary/protocol endpoint

AUC(0-8h)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

AUC(0-168h)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

AUCτ,ss

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Cav,ss

Plasma concentration (steady state)

concentration, descriptive

Primary/protocol endpoint

λ z

descriptive

Primary/protocol endpoint

t½

Half-life

descriptive

Primary/protocol endpoint

CL/F

descriptive

Primary/protocol endpoint

Vss/F

descriptive

Primary/protocol endpoint

Rac

ratio, descriptive

Primary/protocol endpoint

Ctrough

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Electrocardiograms (ECGs)

Time frame:ECGs will be performed at Visit 1 (screening), Visit 3 (Day 1, pre-dose and 2 hours post-dose), Visit 18 (Week 14, Day 1, pre-dose and 2 hours post-dose) and Visit 29 (Week 26, follow-up)

descriptive

Secondary/protocol endpoint

Body temperature

Time frame:Body temperature will be collected at Visit 1, Visit 3 (pre-dose, 2- and 24-hours post-dose), Visit 4 (post-dose), Visit 5 (post-dose), Visit 6-17 (pre-dose), Visit 18 (pre-dose, 2- and 24-hours post-dose), Visit 19-21 (post-dose), Visit 22-29

descriptive

Secondary/protocol endpoint

Safety and tolerability as determined by abnormality in clinical chemistry compared to baseline.

Time frame:Blood sample will be collected at Visit 1 (screening), Visit 2 (admission, day -1), Visit 6 (Week2, pre-dose), Visit 8 (Week4, pre-dose), Visit 17 (Week13, pre-dose), Visit 23 (Week16, follow-up), Visit 29 (Week26, follow-up)

descriptive

Secondary/protocol endpoint

Safety and tolerability as determined by abnormality in hematology compared to baseline.

descriptive

Secondary/protocol endpoint

Safety and tolerability as determined by abnormality in urinalysis compared to baseline.

descriptive

Secondary/protocol endpoint

Fasting blood glucose

Time frame:Blood sample will be collected at Visit1, Visit3 (Day1, pre-dose), Visit4-5 (Day4, Day6, post-dose), Visit6-18 (Week2-14, pre-dose), Visit19 (Week14, Day4, post-dose) and Visit20 (Week14, Day6, post-dose), Visit22-26 (Week15-20) and Visit29 (Week26)

descriptive

LOINC 1558-6

Secondary/protocol endpoint

Calcitonin

Time frame:Blood sample will be collected at Visit1 (screening), Visit21 (Week14, Day7) and Visit29 (Week26, follow-up)

Thyroid event

descriptive

Secondary/protocol endpoint

Number of subjects with adverse events

Time frame:Adverse event will be collected from Visit 1 (screening) to Visit 29 (Week 26, follow-up).

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

The presence and titer of anti-exenatide antibodies

Time frame:Visit 3, Visit 6~18, Visit 21 and Visit 29 (once every visit)

Immunogenicity (ADA)

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.