Brief 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).

Trial Health

On Track

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

3,731

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jun 2011

Typical duration for phase_3

Geographic Reach

27 countries

221 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

3.8 years study duration

First Submitted

Initial submission to the registry

January 6, 2011

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed

5 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2013

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

February 9, 2015

Completed

21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2015

Completed

Last Updated

January 19, 2018

Status Verified

December 1, 2017

Enrollment Period

1.8 years

First QC Date

January 6, 2011

Results QC Date

January 22, 2015

Last Update Submit

December 20, 2017

Conditions

Metabolism and Nutrition Disorder Obesity

Outcome Measures

Primary Outcomes (4)

Change From Baseline in Fasting Body Weight
The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).
Week 0, Week 56
Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.
Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).
At Week 56
Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight
Percentage of subjects losing \>10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).
At 56 weeks
Proportion of Subjects With Onset of Type 2 Diabetes
Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
At 160 weeks

Secondary Outcomes (8)

Change From Baseline in Waist Circumference (cm)
Week 0, Week 56
Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)
Week 0, week 160
Pre-diabetes Status After 56 Weeks of Treatment
Week 0, Week 56
Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment
Week 0, week 160
Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)
Week 0, week 160
+3 more secondary outcomes

Study Arms (5)

Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)

EXPERIMENTAL

Drug: liraglutide

Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)

EXPERIMENTAL

Drug: placebo

Liraglutide Placebo, no Pre-diabetes

PLACEBO COMPARATOR

Drug: placebo

Liraglutide 3.0mg, Pre-diabetes

EXPERIMENTAL

Drug: liraglutide

Liraglutide Placebo, Pre-diabetes

PLACEBO COMPARATOR

Drug: placebo

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).

Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)

placeboDRUG

Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)Liraglutide Placebo, no Pre-diabetes

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Informed consent obtained
Body Mass Index (BMI) of 30.0 kg/m\^2 or above
Body Mass Index (BMI) of 27 kg/m\^2 or above in the presence of co-morbidities of treated or untreated dyslipidemia and/or hypertension
Stable body weight
Preceding failed dietary effort

You may not qualify if:

Known type 1 or type 2 diabetes
Glycosylated haemoglobin (HbA1c) of 6.5 % or above (Screening visit 1) or FPG of 126 mg/dL (7 mmol/L) or above (Screening visit 2) or 2 hour post-challenge (OGTT) plasma glucose of 200 mg/dL (11.1 mmol/L) or above (Screening visit 2)
Screening calcitonin of 50 ng/L or above
Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
Personal history of non-familial medullary thyroid carcinoma
History of acute or chronic pancreatitis
Obesity induced by drug treatment
Use of approved weight lowering pharmacotherapy
Previous surgical treatment of obesity
History of major depressive disorder or suicide attempt
Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)

Contact the study team to confirm eligibility.