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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
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
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
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 endpointsRelative 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
| Group | Value (mean), percentage of reduction in VAT | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 12.49 | 10.4 – 14.6 |
| Placebo | 1.63 | -1.62 – 4.88 |
Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI
Time frame:Baseline, 40 weeks
Visceral fat, change
percent change from baseline, improvement
Absolute Reduction in Visceral Adipose Tissue Volume
Time frame:Baseline, 40 weeks
Visceral fat, change
change from baseline, improvement
Posted result
| Group | Value (mean), Liters | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 0.53 | — |
| Placebo | 0.10 | — |
Relative Percent Reduction in Body Weight
Time frame:Baseline, 40 weeks
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 6.59 | — |
| Placebo | 1.19 | — |
Absolute Reduction in Body Weight
Time frame:Baseline, 40 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), Kilograms | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 6.75 | — |
| Placebo | 1.3 | — |
Relative Percent Reduction in Waist Circumference
Time frame:Baseline, 40 weeks
Waist circumference, change
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 6.90 | — |
| Placebo | 4.16 | — |
Absolute Reduction in Waist Circumference
Time frame:Baseline, 40 weeks
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (mean), cm | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 7.4 | — |
| Placebo | 4.6 | — |
Relative Percent Reduction in Total Body Adipose Tissue
Time frame:Baseline, 40 weeks
Total fat mass
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 9.59 | — |
| Placebo | 0.95 | — |
Absolute Reduction in Total Body Adipose Tissue
Time frame:Baseline, 40 weeks
Total fat mass
change from baseline, improvement
Posted result
| Group | Value (mean), Liters | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 3.76 | — |
| Placebo | 0.42 | — |
Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue
Time frame:Baseline, 40 weeks
Subcutaneous fat, change
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 9.87 | — |
| Placebo | 0.77 | — |
Absolute Reduction in Abdominal Subcutaneous Adipose Tissue
Time frame:Baseline, 40 weeks
Subcutaneous fat, change
change from baseline, improvement
Posted result
| Group | Value (mean), Liters | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 1.52 | — |
| Placebo | 0.15 | — |
Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue
Time frame:Baseline, 40 weeks
Subcutaneous fat, change
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 9.95 | — |
| Placebo | 1.29 | — |
Absolute Reduction in Lower Body Subcutaneous Adipose Tissue
Time frame:Baseline, 40 weeks
Subcutaneous fat, change
change from baseline, improvement
Posted result
| Group | Value (mean), Liters | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 1.51 | — |
| Placebo | 0.19 | — |
Relative Percent Reduction in Total Body Lean Volume
Time frame:Baseline, 40 weeks
Lean mass
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 2.47 | — |
| Placebo | 0.90 | — |
Absolute Reduction in Total Body Lean Volume
Time frame:Baseline, 40 weeks
Lean mass
change from baseline, improvement
Posted result
| Group | Value (mean), Liters | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 0.54 | — |
| Placebo | 0.17 | — |
Relative Percent Reduction in Total Thigh Muscle Volume
Time frame:Baseline, 40 weeks
Lean mass
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 3.48 | — |
| Placebo | 0.68 | — |
Absolute Reduction in Total Thigh Muscle Volume
Time frame:Baseline, 40 weeks
Lean mass
change from baseline, improvement
Posted result
| Group | Value (mean), Liters | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 0.35 | — |
| Placebo | 0.06 | — |
Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent
Time frame:Baseline,40 weeks
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 2.81 | — |
| Placebo | -0.29 | — |
Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent
Time frame:Baseline,40 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), percentage of fat infiltration | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 0.23 | — |
| Placebo | 0.01 | — |
Change From Baseline in VAT/SAT Ratio
Time frame:Baseline, 40 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), ratio | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 0.01 | — |
| Placebo | 0 | — |
Change From Baseline in Total Fat/Fat-free Mass Ratio
Time frame:Baseline, 40 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), ratio | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | -7.23 | — |
| Placebo | 0.01 | — |
Absolute Reduction in Visceral Adipose Tissue Volume
Time frame:Baseline, 40 weeks
Visceral fat, change
change from baseline, improvement
Relative Percent Reduction in Body Weight
Time frame:Baseline, 40 weeks
Body weight, % change
percent change from baseline, improvement
Absolute Reduction in Body Weight
Time frame:Baseline, 40 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Relative Percent Reduction in Waist Circumference
Time frame:Baseline, 40 weeks
Waist circumference, change
percent change from baseline, improvement
Absolute Reduction in Waist Circumference
Time frame:Baseline, 40 weeks
Waist circumference, change
change from baseline, improvement
Relative Percent Reduction in Total Body Adipose Tissue
Time frame:Baseline, 40 weeks
Total fat mass
percent change from baseline, improvement
Absolute Reduction in Total Body Adipose Tissue
Time frame:Baseline, 40 weeks
Total fat mass
change from baseline, improvement
Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue
Time frame:Baseline, 40 weeks
Subcutaneous fat, change
percent change from baseline, improvement
Absolute Reduction in Abdominal Subcutaneous Adipose Tissue
Time frame:Baseline, 40 weeks
Subcutaneous fat, change
change from baseline, improvement
Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue
Time frame:Baseline, 40 weeks
Subcutaneous fat, change
percent change from baseline, improvement
Absolute Reduction in Lower Body Subcutaneous Adipose Tissue
Time frame:Baseline, 40 weeks
Subcutaneous fat, change
change from baseline, improvement
Relative Percent Reduction in Total Body Lean Volume
Time frame:Baseline, 40 weeks
Lean mass
percent change from baseline, improvement
Absolute Reduction in Total Body Lean Volume
Time frame:Baseline, 40 weeks
Lean mass
change from baseline, improvement
Relative Percent Reduction in Total Thigh Muscle Volume
Time frame:Baseline, 40 weeks
percent change from baseline, improvement
Absolute Reduction in Total Thigh Muscle Volume
Time frame:Baseline, 40 weeks
change from baseline, improvement
Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent
Time frame:Baseline,40 weeks
percent change from baseline, improvement
Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent
Time frame:Baseline,40 weeks
change from baseline, improvement
Change From Baseline in VAT/SAT Ratio
Time frame:Baseline, 40 weeks
change from baseline, improvement
Change From Baseline in Total Fat/Fat-free Mass Ratio
Time frame:Baseline, 40 weeks
change from baseline, improvement
Glycemic / diabetes
12 endpointsRelative Percent Change in Fasting Blood Glucose
Time frame:Baseline, 40 weeks
Fasting glucose, change
percent change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | -5.62 | — |
| Placebo | 0.83 | — |
Relative Percent Change in Insulin
Time frame:Baseline, 40 weeks
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 20.58 | — |
| Placebo | 7.73 | — |
Relative Percent Change in HOMA-IR
Time frame:Baseline, 40 weeks
HOMA-IR (insulin sensitivity)
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 15.35 | — |
| Placebo | 11.85 | — |
Absolute Change in Fasting Blood Glucose
Time frame:Baseline,40 weeks
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | -6.49 | — |
| Placebo | -0.22 | — |
Absolute Change in Insulin
Time frame:Baseline, 40 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), mIU/L | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 0.75 | — |
| Placebo | -1.48 | — |
Absolute Change in HOMA-IR
Time frame:Baseline, 40 weeks
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Posted result
| Group | Value (mean), Molar units | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | -0.15 | — |
| Placebo | -0.69 | — |
Relative Percent Change in Fasting Blood Glucose
Time frame:Baseline, 40 weeks
Fasting glucose, change
percent change from baseline, improvement
LOINC 1558-6
Relative Percent Change in Insulin
Time frame:Baseline, 40 weeks
percent change from baseline, improvement
Relative Percent Change in HOMA-IR
Time frame:Baseline, 40 weeks
HOMA-IR (insulin sensitivity)
percent change from baseline, improvement
Absolute Change in Fasting Blood Glucose
Time frame:Baseline,40 weeks
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Absolute Change in Insulin
Time frame:Baseline, 40 weeks
change from baseline, improvement
Absolute Change in HOMA-IR
Time frame:Baseline, 40 weeks
HOMA-IR (insulin sensitivity)
change from baseline, improvement
MASH / liver
4 endpointsRelative Percent Reduction in Liver Fat Percent
Time frame:Baseline, 40 weeks
Liver fat content, change
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 12.37 | — |
| Placebo | -20.63 | — |
Absolute Reduction in Liver Fat Percent
Time frame:Baseline, 40 weeks
Liver fat content, change
change from baseline, improvement
Posted result
| Group | Value (mean), percentage of liver fat | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 2.35 | — |
| Placebo | -0.01 | — |
Relative Percent Reduction in Liver Fat Percent
Time frame:Baseline, 40 weeks
MRI-PDFF, % change
percent change from baseline, improvement
Absolute Reduction in Liver Fat Percent
Time frame:Baseline, 40 weeks
Liver fat content, change
change from baseline, improvement
Heart failure
4 endpointsRelative Percent Change in Nt-proBNP
Time frame:Baseline, 40 weeks
NT-proBNP, change
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 12.10 | — |
| Placebo | 20.47 | — |
Absolute Change in Nt-proBNP
Time frame:Baseline, 40 weeks
NT-proBNP, change
change from baseline, improvement
Posted result
| Group | Value (mean), pg/mL | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | -8.10 | — |
| Placebo | 1.44 | — |
Relative Percent Change in Nt-proBNP
Time frame:Baseline, 40 weeks
NT-proBNP, change
percent change from baseline, improvement
Absolute Change in Nt-proBNP
Time frame:Baseline, 40 weeks
NT-proBNP, change
change from baseline, improvement
Cardiometabolic biomarkers
12 endpointsRelative Percent Change in C-reactive Protein
Time frame:Baseline, 40 weeks
hs-CRP, change
percent change from baseline, improvement
LOINC 30522-7
Posted result
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | -19.91 | — |
| Placebo | 19.02 | — |
Relative Percent Change in Triglyceride/HDL-C Ratio
Time frame:Baseline, 40 weeks
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | -2.10 | — |
| Placebo | -2.18 | — |
Absolute Change in CRP
Time frame:Baseline, 40 weeks
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Posted result
| Group | Value (mean), mg/L | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | -2.18 | — |
| Placebo | -0.64 | — |
Absolute Change in Triglyceride/HDL-C Ratio
Time frame:Baseline, 40 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), ratio | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | -0.02 | — |
| Placebo | -0.16 | — |
Change From Baseline in Heart Rate
Time frame:Baseline, 40 weeks
Heart rate, change
change from baseline, improvement
Posted result
| Group | Value (mean), beats per minute | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 4.84 | — |
| Placebo | 2.67 | — |
Change From Baseline in Blood Pressure
Time frame:Baseline, 40 weeks
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Posted result
| Group | Value (mean), mmHg | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | -5.84 | — |
| Placebo | -0.02 | — |
Relative Percent Change in C-reactive Protein
Time frame:Baseline, 40 weeks
hs-CRP, change
percent change from baseline, improvement
LOINC 30522-7
Relative Percent Change in Triglyceride/HDL-C Ratio
Time frame:Baseline, 40 weeks
percent change from baseline, improvement
Absolute Change in CRP
Time frame:Baseline, 40 weeks
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Absolute Change in Triglyceride/HDL-C Ratio
Time frame:Baseline, 40 weeks
change from baseline, improvement
Change From Baseline in Heart Rate
Time frame:Baseline, 40 weeks
Heart rate, change
change from baseline, improvement
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 endpointOn-treatment Time, Weeks
Time frame:weeks
descriptive
Posted result
| Group | Value (mean), weeks | 95% CI |
|---|---|---|
| Liraglutide 3.0 mg | 36.2 | — |
| Placebo | 36.1 | — |
Other (unclassified)
1 endpointOn-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
- The lancet. Diabetes & endocrinology2021 Sep (month)PMID34358471doi:10.1016/S2213-8587(21)00179-0via clinicaltrials gov reference derived + pubmed nct search
- Journal of the American College of Cardiology2014 Sep 9PMID25190234doi:10.1016/j.jacc.2014.05.057via CT.gov background
- Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2014 Sep (month)PMID25253227doi:10.4158/EP14280.PSvia CT.gov background
- Journal of the American College of Cardiology2014 Mar 25PMID24345592doi:10.1016/j.jacc.2013.11.035via CT.gov background
- Mayo Clinic proceedings2014 Mar (month)PMID24582192doi:10.1016/j.mayocp.2013.11.011via CT.gov background
- International journal of obesity (2005)2013 Nov (month)PMID23812094doi:10.1038/ijo.2013.120via CT.gov background
- Journal of the American College of Cardiology2013 Sep 3PMID23850922doi:10.1016/j.jacc.2013.06.027via CT.gov background
- Circulation. Cardiovascular imaging2013 Sep (month)PMID23929898doi:10.1161/CIRCIMAGING.113.000532via CT.gov background
- International journal of obesity (2005)2012 Jun (month)PMID21844879doi:10.1038/ijo.2011.158via CT.gov background
- The Journal of clinical endocrinology and metabolism2011 Nov (month)PMID21865361doi:10.1210/jc.2011-0615via CT.gov background
- The New England journal of medicine2010 Dec 2PMID21121834doi:10.1056/NEJMoa1000367via CT.gov background
- Lancet (London, England)2009 Nov 7PMID19853906doi:10.1016/S0140-6736(09)61375-1via CT.gov background
- Arteriosclerosis, thrombosis, and vascular biology2008 Jun (month)PMID18356555doi:10.1161/ATVBAHA.107.159228via CT.gov background
- Journal of the American College of Cardiology2007 Aug 21PMID17707180doi:10.1016/j.jacc.2007.04.066via CT.gov background
- Critical pathways in cardiology2005 Dec (month)PMID18340209doi:10.1097/00132577-200512000-00018via CT.gov background
- Lancet (London, England)2005 Sep 24-30 (month)PMID16182882doi:10.1016/S0140-6736(05)67402-8via CT.gov background
- Food and nutrition bulletin2005 Mar (month)PMID15810802via CT.gov background
Provenance
Sources
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.