A Trial to Assess the Effect of Liraglutide on Gastric Emptying in Healthy Obese Volunteers
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity; Healthy
Intervention: liraglutide (Drug); liraglutide (Drug); liraglutide (Drug); liraglutide (Drug); liraglutide (Drug); liraglutide (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Birgitte Sloth, MSc.PhD, Study Director, Affiliation: Novo Nordisk
Overall contact:
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
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.
Clinical Details
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 design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Gastric emptying measured as AUC0-300min of paracetamol postprandial concentration profiles during a standardised meal test with intake of 1.5 g paracetamol
Secondary outcome: Gastric emptying: Cmax and AUC0-60min/AUC0-300min of paracetamol postprandial concentration profiles
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
Maastricht 6229 ER, Netherlands; Recruiting
Additional Information
Clinical Trials at Novo Nordisk
Starting date: September 2009
Last updated: September 16, 2010
|
