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CompletedPhase 1

A Trial to Assess the Effect of Liraglutide on Gastric Emptying in Healthy Obese Volunteers

A Randomised, Placebo-controlled, Double-blind, Incomplete Cross-over Design Trial to Evaluate the Effects of Liraglutide on Gastric Emptying, Energy Expenditure and Appetite, and to Evaluate Liraglutide Pharmacokinetics in Non-diabetic Obese Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

49

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criterion

BMI 30-40

Primary endpoint

Gastric emptying measured as AUC0-300min of paracetamol postprandial

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 IDNCT00978393
Org study IDNN8022-3630
Secondary ID2008-003228-44
Secondary IDU1111-1111-9119WHO

Timeline

Milestones

Study first posted2009-09-16estimated
Study start2009-09-16actual
Primary completion2011-06-08actual
Study completion2011-06-08actual
Last update posted2017-07-27actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Body Mass Index (BMI) between 30.0-40.0 kg/m2
Stable body weight (below 5 kg body weight change during past 3 month)
Fasting plasma glucose below 7.0 mmol/L

Exclusion criteria

Presence or history of cancer or any clinically significant cardiac, metabolic, renal, gastrointestinal, hepatic, endocrine, dermatological, haematological, or psychiatric diseases or disorders, considered by the Investigator to have influence of the results of this trial
History of chronic pancreatitis or idiopathic acute pancreatitis
Current or history of treatment with medications that may cause significant weight gain, within 12 months prior to screening
Use of weight lowering pharmacotherapy within the last 3 months prior to trial start
Previous or scheduled (during the trial period) surgical treatment for obesity
Diagnosed type 1 or type 2 diabetes
Smoking habitually as judged by the Investigator
Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods if not sterile or post-menopausal

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

Safety / tolerability / PK
1
Other (unclassified)
1

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Gastric emptying: Cmax and AUC0-60min/AUC0-300min of paracetamol postprandial concentration profiles

Time frame:after 35 days of treatment

Cmax

concentration, descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Gastric emptying measured as AUC0-300min of paracetamol postprandial concentration profiles during a standardised meal test with intake of 1.5 g paracetamol

Time frame:after 35 days of treatment

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.