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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00978393

Enrollment

Registered

2009-09-16

Start date

2009-09-16

Completion date

2011-06-08

Last updated

2017-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolism and Nutrition Disorder, Obesity

Brief summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the effect of liraglutide on gastric emptying, energy expenditure and appetite, and to evaluate liraglutide pharmacokinetics in non-diabetic obese volunteers. The trial is designed as a two-period, six-sequenced, crossover trial where the trial participant will enter two treatment periods with a wash-out period of 6-8 weeks.

Interventions

DRUGliraglutide

High dose liraglutide treatment (3.0 mg) followed by low dose liraglutide treatment (1.8 mg). Injected s.c. (under the skin) once daily in the evening.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Gastric emptying measured as AUC0-300min of paracetamol postprandial concentration profiles during a standardised meal test with intake of 1.5 g paracetamol	after 35 days of treatment

Secondary

Measure	Time frame
Gastric emptying: Cmax and AUC0-60min/AUC0-300min of paracetamol postprandial concentration profiles	after 35 days of treatment

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026