A Trial to Assess the Effect of Liraglutide on Gastric Emptying in Healthy Obese Volunteers

• Status: Completed
• Trial end date: 2011-06-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Liraglutide

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