Trial Outcomes & Findings for Impact of Liraglutide 3.0 on Body Fat Distribution (NCT NCT03038620)

Results Overview

The effect on relative percent reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment. Positive numbers reflect the reduction in the value from baseline to study endpoint as a percent of the baseline. Reduction in this variable is believed to be associated with lower cardiovascular risk.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

235 participants

Primary outcome timeframe

Baseline, 40 weeks

Results posted on

2021-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	Liraglutide 3.0 mg Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Overall Study STARTED	92	93
Overall Study COMPLETED	73	55
Overall Study NOT COMPLETED	19	38

Reasons for withdrawal

Reasons for withdrawal
Measure	Liraglutide 3.0 mg Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Overall Study Lost to Follow-up	18	23
Overall Study Withdrawal by Subject	0	15
Overall Study Uninterpretable Outcome (Imaging)	1	0

Baseline Characteristics

Impact of Liraglutide 3.0 on Body Fat Distribution

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Total n=128 Participants Total of all reporting groups
Age, Continuous	49.6 years STANDARD_DEVIATION 9.8 • n=5 Participants	50.9 years STANDARD_DEVIATION 8.8 • n=7 Participants	50.2 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	51 Participants n=7 Participants	118 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=5 Participants	43 Participants n=7 Participants	98 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	28 Participants n=5 Participants	19 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	35 Participants n=7 Participants	78 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Total Adipose tissue	39.6 Liters STANDARD_DEVIATION 8.9 • n=5 Participants	40.9 Liters STANDARD_DEVIATION 9.8 • n=7 Participants	40.2 Liters STANDARD_DEVIATION 9.3 • n=5 Participants
Visceral Adipose Tissue	4.5 Liters STANDARD_DEVIATION 2.1 • n=5 Participants	4.5 Liters STANDARD_DEVIATION 1.7 • n=7 Participants	4.5 Liters STANDARD_DEVIATION 1.9 • n=5 Participants
Abdominal Adipose Tissue	15.6 Liters STANDARD_DEVIATION 4.3 • n=5 Participants	16.2 Liters STANDARD_DEVIATION 4.2 • n=7 Participants	15.8 Liters STANDARD_DEVIATION 4.2 • n=5 Participants
Lower Body Adipose Tissue	14.7 Liters STANDARD_DEVIATION 4.3 • n=5 Participants	15.6 Liters STANDARD_DEVIATION 5.0 • n=7 Participants	15.1 Liters STANDARD_DEVIATION 4.6 • n=5 Participants
Liver Fat	7.6 percentage of fat STANDARD_DEVIATION 7.9 • n=5 Participants	6.1 percentage of fat STANDARD_DEVIATION 6.1 • n=7 Participants	6.9 percentage of fat STANDARD_DEVIATION 7.2 • n=5 Participants
Total Body Lean Tissue	21.6 Liters STANDARD_DEVIATION 3.8 • n=5 Participants	21.5 Liters STANDARD_DEVIATION 3.5 • n=7 Participants	21.5 Liters STANDARD_DEVIATION 3.7 • n=5 Participants
Fasting Blood Glucose	100.6 mg/dL STANDARD_DEVIATION 12.9 • n=5 Participants	99.1 mg/dL STANDARD_DEVIATION 14.4 • n=7 Participants	100 mg/dL STANDARD_DEVIATION 13.5 • n=5 Participants
Fasting Insulin	16.3 mIU/L STANDARD_DEVIATION 10.8 • n=5 Participants	18.0 mIU/L STANDARD_DEVIATION 17.0 • n=7 Participants	17.0 mIU/L STANDARD_DEVIATION 13.8 • n=5 Participants
Triglycerides (mg/dL)	109.4 mg/dL STANDARD_DEVIATION 49.7 • n=5 Participants	118.3 mg/dL STANDARD_DEVIATION 50.6 • n=7 Participants	113.2 mg/dL STANDARD_DEVIATION 50.1 • n=5 Participants
C-reactive Protein (mg/L)	8.0 mg/L STANDARD_DEVIATION 4.3 • n=5 Participants	7.8 mg/L STANDARD_DEVIATION 6.8 • n=7 Participants	7.9 mg/L STANDARD_DEVIATION 5.6 • n=5 Participants
N-terminal prohormone of brain natriuretic peptide (NT-proBNP) (pg/mL)	59.6 pg/mL STANDARD_DEVIATION 44.1 • n=5 Participants	63.2 pg/mL STANDARD_DEVIATION 44.7 • n=7 Participants	61.1 pg/mL STANDARD_DEVIATION 44.1 • n=5 Participants
Number of Participants with Hypertension	30 Participants n=5 Participants	20 Participants n=7 Participants	50 Participants n=5 Participants
Number of Participants with Hyperlipidemia	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Number of Participants with Prediabetes	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Systolic blood pressure (mmHg)	130.3 mmHg STANDARD_DEVIATION 14.9 • n=5 Participants	125.8 mmHg STANDARD_DEVIATION 13.9 • n=7 Participants	128.4 mmHg STANDARD_DEVIATION 14.6 • n=5 Participants
Diastolic blood pressure (mmHg)	80.9 mmHg STANDARD_DEVIATION 7.8 • n=5 Participants	78.5 mmHg STANDARD_DEVIATION 8.3 • n=7 Participants	79.8 mmHg STANDARD_DEVIATION 8.1 • n=5 Participants
Weight (kg)	101.0 Kg STANDARD_DEVIATION 17.9 • n=5 Participants	102.3 Kg STANDARD_DEVIATION 17.9 • n=7 Participants	101.5 Kg STANDARD_DEVIATION 17.9 • n=5 Participants
Height (m)	1.6 m STANDARD_DEVIATION 0.1 • n=5 Participants	1.6 m STANDARD_DEVIATION 0.1 • n=7 Participants	1.6 m STANDARD_DEVIATION 0.1 • n=5 Participants
BMI (kg/m^2)	37.2 kg/m^2 STANDARD_DEVIATION 6.0 • n=5 Participants	38.1 kg/m^2 STANDARD_DEVIATION 6.1 • n=7 Participants	37.6 kg/m^2 STANDARD_DEVIATION 6.1 • n=5 Participants
Waist Circumference (cm)	105.5 cm STANDARD_DEVIATION 12.2 • n=5 Participants	104.8 cm STANDARD_DEVIATION 10.6 • n=7 Participants	105.2 cm STANDARD_DEVIATION 11.5 • n=5 Participants
Baseline kcal/day	2177 kcal/day STANDARD_DEVIATION 195 • n=5 Participants	2196 kcal/day STANDARD_DEVIATION 189 • n=7 Participants	2185 kcal/day STANDARD_DEVIATION 192 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed study endpoint assessment (interpretable MRI at baseline and at study end).

The effect on relative percent reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment. Positive numbers reflect the reduction in the value from baseline to study endpoint as a percent of the baseline. Reduction in this variable is believed to be associated with lower cardiovascular risk.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI	12.49 percentage of reduction in VAT Interval 10.4 to 14.6	1.63 percentage of reduction in VAT Interval -1.62 to 4.88

SECONDARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images.

The effect on absolute reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Absolute Reduction in Visceral Adipose Tissue Volume	0.53 Liters Standard Deviation 0.43	0.10 Liters Standard Deviation 0.53

SECONDARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images.

The effect on relative percent reduction from baseline in body weight after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Relative Percent Reduction in Body Weight	6.59 percent change Standard Deviation 4.80	1.19 percent change Standard Deviation 4.68

SECONDARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images.

The effect on absolute reduction from baseline in body weight after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Absolute Reduction in Body Weight	6.75 Kilograms Standard Deviation 5.35	1.3 Kilograms Standard Deviation 4.79

SECONDARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images.

The effect on relative percent reduction from baseline in waist circumference after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Relative Percent Reduction in Waist Circumference	6.90 percent change Standard Deviation 6.43	4.16 percent change Standard Deviation 6.06

SECONDARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images.

The effect on absolute reduction from baseline in waist circumference after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Absolute Reduction in Waist Circumference	7.4 cm Standard Deviation 6.8	4.6 cm Standard Deviation 6.7

SECONDARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images.

The effect on relative percent reduction from baseline in total body adipose tissue (fat) mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Relative Percent Reduction in Total Body Adipose Tissue	9.59 percent change Standard Deviation 7.15	0.95 percent change Standard Deviation 7.80

SECONDARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images.

The effect on absolute reduction from baseline in total body adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Absolute Reduction in Total Body Adipose Tissue	3.76 Liters Standard Deviation 2.87	0.42 Liters Standard Deviation 2.92

SECONDARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images.

The effect on relative percent reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue	9.87 percent change Standard Deviation 8.23	0.77 percent change Standard Deviation 8.40

SECONDARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images.

The effect on absolute reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Absolute Reduction in Abdominal Subcutaneous Adipose Tissue	1.52 Liters Standard Deviation 1.31	0.15 Liters Standard Deviation 1.24

SECONDARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images.

The effect on relative percent reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue	9.95 percent change Standard Deviation 7.61	1.29 percent change Standard Deviation 8.57

SECONDARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images.

The effect on absolute reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Absolute Reduction in Lower Body Subcutaneous Adipose Tissue	1.51 Liters Standard Deviation 1.34	0.19 Liters Standard Deviation 1.19

SECONDARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images.

The effect on relative percent reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Relative Percent Reduction in Liver Fat Percent	12.37 percent change Standard Deviation 61.43	-20.63 percent change Standard Deviation 104.92

SECONDARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images are reported here.

The effect on absolute reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Absolute Reduction in Liver Fat Percent	2.35 percentage of liver fat Standard Deviation 5.35	-0.01 percentage of liver fat Standard Deviation 3.24

SECONDARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images are reported here.

The effect on relative percent reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Relative Percent Reduction in Total Body Lean Volume	2.47 percent change Standard Deviation 4.04	0.90 percent change Standard Deviation 3.66

SECONDARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images are reported here.

The effect on absolute reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Absolute Reduction in Total Body Lean Volume	0.54 Liters Standard Deviation 0.88	0.17 Liters Standard Deviation 0.80

SECONDARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images are reported here.

The effect on relative percent reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Relative Percent Reduction in Total Thigh Muscle Volume	3.48 percent change Standard Deviation 3.55	0.68 percent change Standard Deviation 3.72

SECONDARY outcome

Timeframe: Baseline, 40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images are reported here.

The effect on absolute reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Absolute Reduction in Total Thigh Muscle Volume	0.35 Liters Standard Deviation 0.35	0.06 Liters Standard Deviation 0.38

SECONDARY outcome

Timeframe: Baseline,40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images are reported here.

The effect on relative percent reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower risk for metabolic disease.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent	2.81 percent change Standard Deviation 6.51	-0.29 percent change Standard Deviation 6.96

SECONDARY outcome

Timeframe: Baseline,40 weeks

Population: Those who completed baseline and endpoint MRI with interpretable images are reported here.

The effect on absolute reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower risk for metabolic disease

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent	0.23 percentage of fat infiltration Standard Deviation 0.49	0.01 percentage of fat infiltration Standard Deviation 0.58

SECONDARY outcome

Timeframe: Baseline, 40 weeks

The effect on absolute reduction from baseline in Visceral adipose tissue/subcutaneous adipose tissue (VAT/SAT) ratio measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. This is the ratio of visceral adipose tissue to subcutaneous adipose tissue and it is thought that lower values (relatively less visceral adipose tissue) are better.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=73 Participants Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.	Placebo n=55 Participants Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Change From Baseline in VAT/SAT Ratio	0.01 ratio Standard Deviation 0.03	0 ratio Standard Deviation 0.02

SECONDARY outcome

Timeframe: Baseline, 40 weeks

The effect on absolute change from baseline in total fat/fat-free mass ratio measured by MRI after 40 weeks on treatment versus placebo. This is a ratio of fat to lean mass and it is believed that lower values (less fat relative to lean mass) is better.