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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00978393
First received: September 15, 2009
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Metabolism and Nutrition Disorder
Obesity
Healthy
Drug: liraglutide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Gastric emptying measured as AUC0-300min of paracetamol postprandial concentration profiles during a standardised meal test with intake of 1.5 g paracetamol [ Time Frame: after 35 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gastric emptying: Cmax and AUC0-60min/AUC0-300min of paracetamol postprandial concentration profiles [ Time Frame: after 35 days of treatment ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: September 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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.
Experimental: B Drug: 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.
Experimental: C Drug: 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.
Experimental: D Drug: 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.
Experimental: E Drug: 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.
Experimental: F Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978393

Locations
Netherlands
Maastricht, Netherlands, 6229 ER
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Birgitte Sloth, MSc.PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00978393     History of Changes
Other Study ID Numbers: NN8022-3630, 2008-003228-44, U1111-1111-9119
Study First Received: September 15, 2009
Last Updated: June 26, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Obesity
Nutrition Disorders
Malnutrition
Overnutrition
Overweight
Body Weight
Signs and Symptoms
Liraglutide
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014