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

Novo Nordisk A/S1 site in 1 country49 target enrollmentSeptember 16, 2009

ConditionsMetabolism and Nutrition Disorder Obesity

Interventionsliraglutide

Drugsliraglutide

Overview

Phase: Phase 1
Intervention: liraglutide
Conditions: Metabolism and Nutrition Disorder
Sponsor: Novo Nordisk A/S
Enrollment: 49
Locations: 1
Primary Endpoint: Gastric emptying measured as AUC0-300min of paracetamol postprandial concentration profiles during a standardised meal test with intake of 1.5 g paracetamol
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 16, 2009

End Date

June 8, 2011

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

A

Intervention: liraglutide

B

Intervention: liraglutide

C

Intervention: liraglutide

D

Intervention: liraglutide

E

Intervention: liraglutide

F

Intervention: liraglutide

Outcomes

Primary Outcomes

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