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Completed

NCT Number: NCT00978393

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

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.

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Key information

Conditions

Metabolism and Nutrition Disorder Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Maastricht, 6229 ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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 outcomes

  1. Gastric emptying: Cmax and AUC0-60min/AUC0-300min of paracetamol postprandial concentration profiles

    Time frame: after 35 days of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 16, 2009
Registry last updated
Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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