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

Sponsor
Novo Nordisk A/S
Study ID
NCT00978393
Phase
PHASE1
Status
Completed

Conditions

  • Metabolism and Nutrition Disorder
  • Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • liraglutide — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 16, 2009
Status verified
Jul 2017
Primary completion
Jun 8, 2011
Completion
Jun 8, 2011

Study Design

Enrollment
49 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: A
  • Experimental: B
  • Experimental: C
  • Experimental: D
  • Experimental: E
  • Experimental: F

Primary Outcome Measure

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 ]

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