Obesity Clinical Trial
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
Verified date | July 2017 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | June 8, 2011 |
Est. primary completion date | June 8, 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Novo Nordisk Investigational Site | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
Netherlands,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Gastric emptying: Cmax and AUC0-60min/AUC0-300min of paracetamol postprandial concentration profiles | after 35 days of treatment |
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