DelfaGLP-1 Atlas

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CompletedPhase 1

Feasibility Study of Exenatide by Continuous Subcutaneous Infusion

An Open-Label Exploratory Study to Investigate the Feasibility of Administering Exenatide by Continuous Subcutaneous Infusion to Healthy Subjects

Lead sponsor

GlaxoSmithKline

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

10

actual

Study population

Healthy volunteers

Key I/E criterion

•Healthy volunteers

Primary endpoints

•Characterization of interruptions or deviations from prescribed exenatide•Infusion rate adjustments when nausea/vomiting occurs in Part B•Treatment-emergent 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 IDNCT01857895
Org study ID200016

Timeline

Milestones

Study start2013-05-16actual
Study first posted2013-05-20estimated
Primary completion2013-11-01actual
Study completion2013-11-01actual
Last update posted2017-10-19actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Male/females aged between 18 and 60 years of age inclusive, at the time of signing the informed consent.
•Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECG. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator agrees and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures and objectives.
•Body Mass Index within the range 18 to 35 kilograms/meter squared (kg/m^2) inclusive.
•A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases a blood sample with simultaneous follicle stimulating hormone > 40 milli international unit/mililiter (mL) and estradiol <40 picogram/mL (<147 picomoles/Liter) is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
•Child-bearing potential females must agree to use one of the contraception methods. This criterion must be followed from the time of the first dose of study medication until follow up visit.
•Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
•Based on QT interval corrected for heart rate (QTc) of single electrocardiogram (ECG): QTc by Fridericia's formula <450 millisecond (msec).
•Aspartate aminotransferase and Alanine aminotransferase <2x upper limit of normal (ULN); alkaline phosphatase and bilirubin <= 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

Exclusion criteria

•Subjects with a personal or family history of thyroid carcinoma or Type 2 Familial Endocrine Neoplasia.
•History of uncorrected thyroid dysfunction or an abnormal thyroid functions as assessed by thyroid stimulating hormones.
•Subjects with a history of severe gastrointestinal disease, or abnormal renal function.
•Subjects with previous exposure to a Glucagon-like peptide-1 mimetic.
•History of chronic or acute pancreatitis. Note: Subjects with a lipase value above 1.5X ULN at screening are excluded.
•Current or chronic history of liver disease, or hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
•History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
•History of sensitivity to heparin or heparin-induced thrombocytopenia.
•History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.

Criteria Based Upon Diagnostic Assessments

•A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
•A positive pre-study drug/alcohol screen.
•A subject with a positive urine cotinine test result will be excluded from the study unless in the judgment of the Investigator the subject will be able to abstain from using tobacco for the duration of the in-house period of the study.
•A positive test for human immuno virus antibody.

Other Criteria

•Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
•The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
•Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

Endpoints (11)

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
10
Cardiometabolic biomarkers
1

Cardiometabolic biomarkers

1 endpoint
Primary/protocol endpoint

Vital sign assessment in Part B

Time frame:23 days

descriptive

Safety / tolerability / PK

10 endpoints
Primary/protocol endpoint

Characterization of interruptions or deviations from prescribed exenatide infusion in Part A

Time frame:2 days

descriptive

Primary/protocol endpoint

Characterization of interruptions or deviations from prescribed exenatide infusion in Part B

Time frame:8 days

descriptive

Primary/protocol endpoint

Infusion rate adjustments when nausea/vomiting occurs in Part B

Time frame:8 days

descriptive

Primary/protocol endpoint

Number of participants with adverse events (AEs) in Part A

Time frame:17 days

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Number of participants with AEs in Part B

Time frame:23 days

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Laboratory parameter assessment in Part A

Time frame:17 days

descriptive

Primary/protocol endpoint

Laboratory parameter assessment in Part B

Time frame:23 days

descriptive

Primary/protocol endpoint

Vital sign assessment in Part A

Time frame:17 days

descriptive

Secondary/protocol endpoint

Pharmacokinetic (PK) profile of exenatide in Part A

Time frame:PK samples will be collected at pre-dose, and at 0.5, 1, 2, 4, 6, 10, 14, 24, and 26 hours post dose.

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic (PK) profile of exenatide in Part B

Time frame:8 days

AUC₀–∞

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.