A Trial to Assess the Effect of Liraglutide on Gastric Emptying in Healthy Obese Volunteers
- Registration Number
- NCT00978393
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A liraglutide - B liraglutide - C liraglutide - E liraglutide - F liraglutide - D liraglutide -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Gastric emptying: Cmax and AUC0-60min/AUC0-300min of paracetamol postprandial concentration profiles after 35 days of treatment
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇳🇱Maastricht, Netherlands