Clinical trial NCT00978393: A Trial to Assess the Effect of Liraglutide on Gastric Emptying in Healthy Obese Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-09-16
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Gastric emptying measured as AUC0-300min of paracetamol postprandial concentration profiles during a standardised meal test with intake of 1.5 g paracetamol
timeFrame: after 35 days of treatment
Secondary outcomes:
measure: Gastric emptying: Cmax and AUC0-60min/AUC0-300min of paracetamol postprandial concentration profiles
timeFrame: after 35 days of treatment
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: van Can J, Sloth B, Jensen CB, Flint A, Blaak EE, Saris WH. Effects of the once-daily GLP-1 analog liraglutide on gastric emptying, glycemic parameters, appetite and energy metabolism in obese, non-diabetic adults. Int J Obes (Lond). 2014 Jun;38(6):784-93. doi: 10.1038/ijo.2013.162. Epub 2013 Sep 3.