DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT01056549

CompletedPhase NA

Exenatide (Byetta ®) Regulation of Intestinal and Hepatic Lipoprotein Particle Production in Humans

Exenatide (Byetta ®) Regulation of Intestinal and Hepatic Lipoprotein Particle Production in Humans.

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

15

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI 20-25

Primary endpoint

•Objective is to examine the change in apoB48 production rate after one

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 IDNCT01056549
Org study IDREB 09-0428-B

Timeline

Milestones

Study first posted2010-01-26estimated
Last update posted2012-06-22estimated
Study start2010-01 (month precision)
Primary completion2011-09actual (month precision)
Study completion2011-09actual (month precision)

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

1. Men and women, aged 18 to 60 years

2. Body mass index 20 kg/m2 to 25 kg/m2

3. Hemoglobin above 130g/L.

4. Normal glucose tolerance in response to a 75g, 2-hr OGTT

Exclusion criteria

1. Subject has a history of hepatitis/hepatic disease that has been active within the previous two years.

2. Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr > 1.5 mg/dL), genitourinary, hematological systems, or has severe uncontrolled treated or untreated hypertension (sitting diastolic BP > 100 or systolic > 180) or proliferative retinopathy

3. History of diabetes or OGTT indicative of diabetes or impaired glucose tolerance.

4. Any history of a MI or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ECG, unstable angina, or decompensated heart failure.

5. Any laboratory values: AST > 2x ULN; ALT > 2x ULN TSH > 6 mU/l

6. Current addiction to alcohol or substances of abuse as determined by the investigator.

7. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation

8. Taking any prescription or non-prescription medications at the time of the study

9. Having donated blood three months prior to and three months post study procedures

10. A pregnancy test will be performed 1 to 3 days prior to each study in all female subjects. Those who test positive for pregnancy will be excluded.

11. No clinical evidence of neoplasms which have been known to overexpress GLP-1 receptors i.e. pheochromocytomas, brain tumors and embryonic tumors.

12. Hypersensitivity to egg-, soya-,or peanut protein or previous allergy to intralipid

13. Those with known sensitivity to metoclopramide

Endpoints (2)

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

Cardiometabolic biomarkers
1
Other (unclassified)
1

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint/low confidence

The secondary objective is to examine the change in apoB100 production rate in the same conditions, and the secondary measure is the difference between exenatide and placebo in the mean production of TRL-apoB100

Time frame:over 10 hours

change from baseline, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

The objective is to examine the change in apoB48 production rate after one subcutaneous injection of exenatide, under conditions of a pancreatic clamp and a steady state fed state.

Time frame:over 10 hours

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.