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CompletedPhase 4Results posted

Impact of Liraglutide 3.0 on Body Fat Distribution

Impact of Liraglutide 3.0 on Body Fat Distribution, Visceral Adiposity, and Cardiometabolic Risk Markers In Overweight and Obese Adults at High Risk for Cardiovascular Disease

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

235

actual

Study population

Metabolic syndrome, Obesity / overweight

Key I/E criterion

BMI ≥30

Primary endpoint

Visceral fat, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03038620
Org study IDSTU 122015-044

Timeline

Milestones

Study first posted2017-01-31estimated
Primary completion2020-10-13actual
Study completion2020-10-13actual
Last update posted2021-11-19actual
Results first posted2021-11-19actual
Study start2017-01actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Metabolic syndromeObesity / overweight

Eligibility

Who can enroll

Minimum age35 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Age ≥ 35 years
Able to provide informed consent
BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with metabolic syndrome
Metabolic syndrome is defined as at least three of the following:3

1. waist circumference > 102 cm (40 in) in men and 88 cm (35 in) in women

2. triglycerides > 150 mg/dL or on treatment for hypertriglyceridemia

3. HDL cholesterol < 40 mg/dL in men and < 50 mg/dL in women

4. blood pressure > 130/85 mmHg or on treatment for hypertension

5. fasting glucose > 100 mg/dL

Exclusion criteria

Treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists (including liraglutide, exenatide or others as they become available), dipeptidyl peptidase 4 (DPP-4) inhibitors or insulin within the last 3 months.
Receipt of any anti-obesity drug or supplement within 1 month prior to screening for this trial.
Self-reported or clinically documented history of significant fluctuations (>5% change) in weight within 3 months prior to screening for this trial.
History of diabetes mellitus (type 1 or 2) or on treatment with anti-diabetes medication.
History of chronic pancreatitis or idiopathic acute pancreatitis (current or prior history).
History of gallbladder disease (cholelithiasis or cholecystitis).
Chronic kidney disease stage III or greater (eGFR<60 mL/min).
Obesity induced by other endocrinologic disorders (e.g. Cushing Syndrome).
Current or history of treatment with medications that may cause significant weight gain, within 1 month prior to screening for this trial, including systemic corticosteroids (except for a short course of treatment, i.e., 7- 10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g., imipramine, amitryptiline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium).
Diet attempts using herbal supplements or over-the-counter medications within 1 month prior to screening for this trial.
Current participation in an organized weight reduction program or within the last 1 month prior to screening for this trial.
Participation in a clinical trial within the last 3 months prior to screening for this trial.
Familial or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma.
Personal history of non-familial medullary thyroid carcinoma.
History of Major Depressive Disorder within the last 2 years.
History of other severe psychiatric disorders, e.g., schizophrenia, bipolar disorder.
Any lifetime history of a suicide attempt.
A history of any suicidal behavior in the last month prior to randomization.
Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the Investigator.
Known or suspected hypersensitivity to trial product(s) or related product(s).
Known or suspected abuse of alcohol or narcotics.
Language barrier, mental incapacity, unwillingness or inability to understand.
Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. These include abstinence and the following methods: diaphragm with spermicide, condom with spermicide (by male partner), intrauterine device, sponge, spermicide, Norplant®, Depo-Provera® or oral contraceptives.

Endpoints (74)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
40
Glycemic / diabetes
12
Cardiometabolic biomarkers
12
MASH / liver
4
Heart failure
4
Safety / tolerability / PK
1
Other (unclassified)
1

Weight & body composition

40 endpoints
Primary/registry result

Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI

Time frame:Baseline, 40 weeks

Visceral fat, change

percent change from baseline, improvement

Posted result

GroupValue (mean), percentage of reduction in VAT95% CI
Liraglutide 3.0 mg12.4910.4 – 14.6
Placebo1.63-1.62 – 4.88
Primary/protocol endpoint

Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI

Time frame:Baseline, 40 weeks

Visceral fat, change

percent change from baseline, improvement

Secondary/registry result

Absolute Reduction in Visceral Adipose Tissue Volume

Time frame:Baseline, 40 weeks

Visceral fat, change

change from baseline, improvement

Posted result

GroupValue (mean), Liters95% CI
Liraglutide 3.0 mg0.53
Placebo0.10
Secondary/registry result

Relative Percent Reduction in Body Weight

Time frame:Baseline, 40 weeks

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
Liraglutide 3.0 mg6.59
Placebo1.19
Secondary/registry result

Absolute Reduction in Body Weight

Time frame:Baseline, 40 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), Kilograms95% CI
Liraglutide 3.0 mg6.75
Placebo1.3
Secondary/registry result

Relative Percent Reduction in Waist Circumference

Time frame:Baseline, 40 weeks

Waist circumference, change

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
Liraglutide 3.0 mg6.90
Placebo4.16
Secondary/registry result

Absolute Reduction in Waist Circumference

Time frame:Baseline, 40 weeks

Waist circumference, change

change from baseline, improvement

Posted result

GroupValue (mean), cm95% CI
Liraglutide 3.0 mg7.4
Placebo4.6
Secondary/registry result

Relative Percent Reduction in Total Body Adipose Tissue

Time frame:Baseline, 40 weeks

Total fat mass

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
Liraglutide 3.0 mg9.59
Placebo0.95
Secondary/registry result

Absolute Reduction in Total Body Adipose Tissue

Time frame:Baseline, 40 weeks

Total fat mass

change from baseline, improvement

Posted result

GroupValue (mean), Liters95% CI
Liraglutide 3.0 mg3.76
Placebo0.42
Secondary/registry result

Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue

Time frame:Baseline, 40 weeks

Subcutaneous fat, change

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
Liraglutide 3.0 mg9.87
Placebo0.77
Secondary/registry result

Absolute Reduction in Abdominal Subcutaneous Adipose Tissue

Time frame:Baseline, 40 weeks

Subcutaneous fat, change

change from baseline, improvement

Posted result

GroupValue (mean), Liters95% CI
Liraglutide 3.0 mg1.52
Placebo0.15
Secondary/registry result

Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue

Time frame:Baseline, 40 weeks

Subcutaneous fat, change

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
Liraglutide 3.0 mg9.95
Placebo1.29
Secondary/registry result

Absolute Reduction in Lower Body Subcutaneous Adipose Tissue

Time frame:Baseline, 40 weeks

Subcutaneous fat, change

change from baseline, improvement

Posted result

GroupValue (mean), Liters95% CI
Liraglutide 3.0 mg1.51
Placebo0.19
Secondary/registry result

Relative Percent Reduction in Total Body Lean Volume

Time frame:Baseline, 40 weeks

Lean mass

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
Liraglutide 3.0 mg2.47
Placebo0.90
Secondary/registry result

Absolute Reduction in Total Body Lean Volume

Time frame:Baseline, 40 weeks

Lean mass

change from baseline, improvement

Posted result

GroupValue (mean), Liters95% CI
Liraglutide 3.0 mg0.54
Placebo0.17
Secondary/registry result

Relative Percent Reduction in Total Thigh Muscle Volume

Time frame:Baseline, 40 weeks

Lean mass

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
Liraglutide 3.0 mg3.48
Placebo0.68
Secondary/registry result

Absolute Reduction in Total Thigh Muscle Volume

Time frame:Baseline, 40 weeks

Lean mass

change from baseline, improvement

Posted result

GroupValue (mean), Liters95% CI
Liraglutide 3.0 mg0.35
Placebo0.06
Secondary/registry result

Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent

Time frame:Baseline,40 weeks

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
Liraglutide 3.0 mg2.81
Placebo-0.29
Secondary/registry result

Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent

Time frame:Baseline,40 weeks

change from baseline, improvement

Posted result

GroupValue (mean), percentage of fat infiltration95% CI
Liraglutide 3.0 mg0.23
Placebo0.01
Secondary/registry result

Change From Baseline in VAT/SAT Ratio

Time frame:Baseline, 40 weeks

change from baseline, improvement

Posted result

GroupValue (mean), ratio95% CI
Liraglutide 3.0 mg0.01
Placebo0
Secondary/registry result

Change From Baseline in Total Fat/Fat-free Mass Ratio

Time frame:Baseline, 40 weeks

change from baseline, improvement

Posted result

GroupValue (mean), ratio95% CI
Liraglutide 3.0 mg-7.23
Placebo0.01
Secondary/protocol endpoint

Absolute Reduction in Visceral Adipose Tissue Volume

Time frame:Baseline, 40 weeks

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Relative Percent Reduction in Body Weight

Time frame:Baseline, 40 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Reduction in Body Weight

Time frame:Baseline, 40 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Relative Percent Reduction in Waist Circumference

Time frame:Baseline, 40 weeks

Waist circumference, change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Reduction in Waist Circumference

Time frame:Baseline, 40 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Relative Percent Reduction in Total Body Adipose Tissue

Time frame:Baseline, 40 weeks

Total fat mass

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Reduction in Total Body Adipose Tissue

Time frame:Baseline, 40 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue

Time frame:Baseline, 40 weeks

Subcutaneous fat, change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Reduction in Abdominal Subcutaneous Adipose Tissue

Time frame:Baseline, 40 weeks

Subcutaneous fat, change

change from baseline, improvement

Secondary/protocol endpoint

Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue

Time frame:Baseline, 40 weeks

Subcutaneous fat, change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Reduction in Lower Body Subcutaneous Adipose Tissue

Time frame:Baseline, 40 weeks

Subcutaneous fat, change

change from baseline, improvement

Secondary/protocol endpoint

Relative Percent Reduction in Total Body Lean Volume

Time frame:Baseline, 40 weeks

Lean mass

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Reduction in Total Body Lean Volume

Time frame:Baseline, 40 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Relative Percent Reduction in Total Thigh Muscle Volume

Time frame:Baseline, 40 weeks

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Reduction in Total Thigh Muscle Volume

Time frame:Baseline, 40 weeks

change from baseline, improvement

Secondary/protocol endpoint

Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent

Time frame:Baseline,40 weeks

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent

Time frame:Baseline,40 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in VAT/SAT Ratio

Time frame:Baseline, 40 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Total Fat/Fat-free Mass Ratio

Time frame:Baseline, 40 weeks

change from baseline, improvement

Glycemic / diabetes

12 endpoints
Secondary/registry result

Relative Percent Change in Fasting Blood Glucose

Time frame:Baseline, 40 weeks

Fasting glucose, change

percent change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), percent change95% CI
Liraglutide 3.0 mg-5.62
Placebo0.83
Secondary/registry result

Relative Percent Change in Insulin

Time frame:Baseline, 40 weeks

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
Liraglutide 3.0 mg20.58
Placebo7.73
Secondary/registry result

Relative Percent Change in HOMA-IR

Time frame:Baseline, 40 weeks

HOMA-IR (insulin sensitivity)

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
Liraglutide 3.0 mg15.35
Placebo11.85
Secondary/registry result

Absolute Change in Fasting Blood Glucose

Time frame:Baseline,40 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), mg/dL95% CI
Liraglutide 3.0 mg-6.49
Placebo-0.22
Secondary/registry result/low confidence

Absolute Change in Insulin

Time frame:Baseline, 40 weeks

change from baseline, improvement

Posted result

GroupValue (mean), mIU/L95% CI
Liraglutide 3.0 mg0.75
Placebo-1.48
Secondary/registry result

Absolute Change in HOMA-IR

Time frame:Baseline, 40 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

GroupValue (mean), Molar units95% CI
Liraglutide 3.0 mg-0.15
Placebo-0.69
Secondary/protocol endpoint

Relative Percent Change in Fasting Blood Glucose

Time frame:Baseline, 40 weeks

Fasting glucose, change

percent change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Relative Percent Change in Insulin

Time frame:Baseline, 40 weeks

percent change from baseline, improvement

Secondary/protocol endpoint

Relative Percent Change in HOMA-IR

Time frame:Baseline, 40 weeks

HOMA-IR (insulin sensitivity)

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Change in Fasting Blood Glucose

Time frame:Baseline,40 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Absolute Change in Insulin

Time frame:Baseline, 40 weeks

change from baseline, improvement

Secondary/protocol endpoint

Absolute Change in HOMA-IR

Time frame:Baseline, 40 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

MASH / liver

4 endpoints
Secondary/registry result

Relative Percent Reduction in Liver Fat Percent

Time frame:Baseline, 40 weeks

Liver fat content, change

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
Liraglutide 3.0 mg12.37
Placebo-20.63
Secondary/registry result

Absolute Reduction in Liver Fat Percent

Time frame:Baseline, 40 weeks

Liver fat content, change

change from baseline, improvement

Posted result

GroupValue (mean), percentage of liver fat95% CI
Liraglutide 3.0 mg2.35
Placebo-0.01
Secondary/protocol endpoint

Relative Percent Reduction in Liver Fat Percent

Time frame:Baseline, 40 weeks

MRI-PDFF, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Reduction in Liver Fat Percent

Time frame:Baseline, 40 weeks

Liver fat content, change

change from baseline, improvement

Heart failure

4 endpoints
Secondary/registry result

Relative Percent Change in Nt-proBNP

Time frame:Baseline, 40 weeks

NT-proBNP, change

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
Liraglutide 3.0 mg12.10
Placebo20.47
Secondary/registry result

Absolute Change in Nt-proBNP

Time frame:Baseline, 40 weeks

NT-proBNP, change

change from baseline, improvement

Posted result

GroupValue (mean), pg/mL95% CI
Liraglutide 3.0 mg-8.10
Placebo1.44
Secondary/protocol endpoint

Relative Percent Change in Nt-proBNP

Time frame:Baseline, 40 weeks

NT-proBNP, change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Change in Nt-proBNP

Time frame:Baseline, 40 weeks

NT-proBNP, change

change from baseline, improvement

Cardiometabolic biomarkers

12 endpoints
Secondary/registry result

Relative Percent Change in C-reactive Protein

Time frame:Baseline, 40 weeks

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Posted result

GroupValue (mean), percent change95% CI
Liraglutide 3.0 mg-19.91
Placebo19.02
Secondary/registry result

Relative Percent Change in Triglyceride/HDL-C Ratio

Time frame:Baseline, 40 weeks

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
Liraglutide 3.0 mg-2.10
Placebo-2.18
Secondary/registry result

Absolute Change in CRP

Time frame:Baseline, 40 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Posted result

GroupValue (mean), mg/L95% CI
Liraglutide 3.0 mg-2.18
Placebo-0.64
Secondary/registry result

Absolute Change in Triglyceride/HDL-C Ratio

Time frame:Baseline, 40 weeks

change from baseline, improvement

Posted result

GroupValue (mean), ratio95% CI
Liraglutide 3.0 mg-0.02
Placebo-0.16
Secondary/registry result

Change From Baseline in Heart Rate

Time frame:Baseline, 40 weeks

Heart rate, change

change from baseline, improvement

Posted result

GroupValue (mean), beats per minute95% CI
Liraglutide 3.0 mg4.84
Placebo2.67
Secondary/registry result

Change From Baseline in Blood Pressure

Time frame:Baseline, 40 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

GroupValue (mean), mmHg95% CI
Liraglutide 3.0 mg-5.84
Placebo-0.02
Secondary/protocol endpoint

Relative Percent Change in C-reactive Protein

Time frame:Baseline, 40 weeks

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Relative Percent Change in Triglyceride/HDL-C Ratio

Time frame:Baseline, 40 weeks

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Change in CRP

Time frame:Baseline, 40 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Absolute Change in Triglyceride/HDL-C Ratio

Time frame:Baseline, 40 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Heart Rate

Time frame:Baseline, 40 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Blood Pressure

Time frame:Baseline, 40 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Safety / tolerability / PK

1 endpoint
Other_pre_specified/registry result

On-treatment Time, Weeks

Time frame:weeks

descriptive

Posted result

GroupValue (mean), weeks95% CI
Liraglutide 3.0 mg36.2
Placebo36.1

Other (unclassified)

1 endpoint
Other/protocol endpoint/low confidence

On-treatment Time, Weeks

Time frame:weeks

descriptive

Publications (26)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.