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The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes

NCT00422058 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 564

Last updated 2017-11-01

Study results available
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Summary

This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the efficacy of liraglutide to induce body weight loss and the purpose of the extension is to evaluate the long term safety and tolerability of liraglutide.

Trial has the following trial periods: A 20-week randomised, double-blind, placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open label orlistat comparator arm followed by an 84 week extension period.

Conditions

  • Metabolism and Nutrition Disorder
  • Obesity

Interventions

DRUG

liraglutide

Injected s.c. (under the skin) once daily

DRUG

orlistat

120 mg capsule. Administered thrice daily

DRUG

placebo

Injected s.c. (under the skin) once daily

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-10
Primary Completion
2007-09-13
Completion
2009-04-30

Countries

  • Belgium
  • Czechia
  • Denmark
  • Finland
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00422058 on ClinicalTrials.gov