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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00978393
First received: September 15, 2009
Last updated: July 25, 2017
Last verified: July 2017
  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 Drug: liraglutide Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Gastric emptying: Cmax and AUC0-60min/AUC0-300min of paracetamol postprandial concentration profiles [ Time Frame: after 35 days of treatment ]

Enrollment: 49
Actual Study Start Date: September 16, 2009
Study Completion Date: June 8, 2011
Primary Completion Date: June 8, 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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Novo Nordisk Investigational Site
Maastricht, Netherlands, 6229 ER
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00978393     History of Changes
Other Study ID Numbers: NN8022-3630
2008-003228-44 ( EudraCT Number )
U1111-1111-9119 ( Other Identifier: WHO )
Study First Received: September 15, 2009
Last Updated: July 25, 2017

Additional relevant MeSH terms:
Nutrition Disorders
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 21, 2017