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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978393
• Other study ID #: NN8022-3630
• Secondary ID: 2008-003228-44U1
• Status: Completed
• Phase: Phase 1
• First received: September 15, 2009
• Last updated: July 25, 2017
• Start date: September 16, 2009
• Est. completion date: June 8, 2011

Study information

• Verified date: July 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity

Intervention

Drug:
• liraglutide
High dose liraglutide treatment (3.0 mg) followed by low dose liraglutide treatment (1.8 mg). Injected s.c. (under the skin) once daily in the evening.
• liraglutide
Low dose liraglutide treatment (1.8 mg) followed by high dose liraglutide treatment (3.0 mg). Injected s.c. (under the skin) once daily in the evening.
• liraglutide
Low dose liraglutide treatment (1.8 mg) followed by high placebo treatment (3.0 mg). Injected s.c. (under the skin) once daily in the evening.
• liraglutide
High placebo treatment (3.0 mg) followed by low dose liraglutide treatment (1.8 mg). Injected s.c. (under the skin) once daily in the evening.
• liraglutide
High dose liraglutide treatment (3.0) followed by low placebo treatment (1.8 mg). Injected s.c. (under the skin) once daily in the evening.
• liraglutide
Low placebo treatment (1.8 mg) followed by high dose liraglutide treatment (3.0 mg). Injected s.c. (under the skin) once daily in the evening.

Locations

Country	Name	City	State
Netherlands	Novo Nordisk Investigational Site	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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

Outcome

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

External Links

•   Clinical Trials at Novo Nordisk