NCT00422058|CompletedPhase 2Results

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

Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes: A 20-week Randomised, Double-blind, Placebo-controlled, Six Armed Parallel Group, Multi-centre, Multinational Trial With an Open Label Orlistat Comparator Arm and With an 84-week Extension Period

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN8022-18072006-004481-13

Study Type

interventional

Target

564

Locations

8 countries

Sites

Timeline

RegisteredJan 2007

StartedJan 2007

CompletionApr 2009

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

564

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jan 2007

Geographic Reach

8 countries

19 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

Study Start

First participant enrolled

January 10, 2007

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2007

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2007

Completed

1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2009

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

October 28, 2010

Completed

Last Updated

November 1, 2017

Status Verified

September 1, 2017

Enrollment Period

8 months

First QC Date

January 12, 2007

Results QC Date

April 27, 2010

Last Update Submit

September 29, 2017

Conditions

Metabolism and Nutrition Disorder Obesity

Outcome Measures

Primary Outcomes (1)

Mean Change From Baseline in Body Weight at Week 20
Calculated as mean body weight at week 20 - baseline
Week 0, week 20

Secondary Outcomes (19)

Mean Change From Baseline in Body Weight at Week 104
Week 0, week 104
Change From Baseline in Fasting Plasma Glucose at Week 20
Week 0, week 20
Change From Baseline in Fasting Plasma Glucose at Week 104
Week 0, week 104
Change From Baseline in Fasting Insulin at Week 20
Week 0, week 20
Change From Baseline in Fasting Insulin at Week 104
Week 0, week 104
+14 more secondary outcomes

Study Arms (6)

Lira placebo/Lira 2.4 mg/Lira 3.0 mg

PLACEBO COMPARATOR

Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)

Drug: placebo

Lira 1.2 mg/Lira 3.0 mg

EXPERIMENTAL

Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)

Drug: liraglutide

Lira 1.8 mg/Lira 3.0 mg

EXPERIMENTAL

Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)

Drug: liraglutide

Lira 2.4 mg/Lira 3.0 mg

EXPERIMENTAL

Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)

Drug: liraglutide

Liraglutide 3.0 mg

EXPERIMENTAL

Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)

Drug: liraglutideDrug: placebo

Orlistat

ACTIVE COMPARATOR

Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)

Drug: orlistat

Interventions

liraglutideDRUG

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

Lira 1.2 mg/Lira 3.0 mgLira 1.8 mg/Lira 3.0 mgLira 2.4 mg/Lira 3.0 mgLiraglutide 3.0 mg

orlistatDRUG

120 mg capsule. Administered thrice daily

Orlistat

placeboDRUG

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

Lira placebo/Lira 2.4 mg/Lira 3.0 mgLiraglutide 3.0 mg

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Body Mass Index (BMI) greater than or equal to 30.0 or lesser than or equal to 40.0 kg/m2
Stable body weight (less than 5% selfreported change within the last 3 months)

You may not qualify if:

Obesity induced by drug treatment
Use of approved drugs for weight lowering intervention (e.g. orlistat, sibutramin, rimonabant) within the last 3 months prior to entering trial
Type 1 or type 2 diabetes

Contact the study team to confirm eligibility.