CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,731 enrolled
Drug / intervention
liraglutide +3 moredrug
Likely dose
liraglutide 3.0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01272219
NCT01272219Phase 3Completed
CompareCT.gov

Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Trial With Stratification of Subject to Either 56 or 160 Weeks of Treatment Based on Pre-diabetes Status at Randomisation

Novo Nordisk A/S·interventional·Posted Jan 7, 2011·Updated Jan 19, 2018

In Brief

A Phase 3 clinical trial evaluating liraglutide and placebo for Metabolism and Nutrition Disorder and Obesity. Completed, enrolled 3,731 participants across 226 sites in 29 countries.

Detailed Summary

This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America. The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline. Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolism and Nutrition Disorder, Obesity
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Poland, Russia, Serbia, Serbia and Montenegro, South Africa, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 7, 2011
Enrollment StartJun 1, 2011
Primary CompletionMar 18, 2013
Study CompletionMar 2, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.5 years ago

Interventions

liraglutidedrug

Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide 3.0 mg for 12 weeks (until week 68).

placebodrug

Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide placebo for 12 weeks (until week 68).

liraglutidedrug

Liraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks.

placebodrug

Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.