GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4Results posted

The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis

The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis - a Single-center Randomized Controlled Study

Lead sponsor

Helsinki University Central Hospital

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI 27-40

Primary endpoints

•Liver fat content, change•Triglycerides, change•Body weight, absolute change (kg)

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 IDNCT02765399

Org study IDLIRA

Timeline

Milestones

Study start2015-02-01actual

Study first posted2016-05-06estimated

Primary completion2019-02-28actual

Study completion2019-02-28actual

Last update posted2022-04-12actual

Results first posted2022-04-12actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subjects with type 2 diabetes treated with a lifestyle or metformin (any dose)

•waist circumference > 88 cm in women and > 92 cm in men

•BMI 27-40 kg/m2

•triglycerides between 1.0 - 4.0 mmol/L

•LDL < 4.5 mmol/l

Exclusion criteria

•Type 1 diabetes

•Apo E2/2 phenotype

•ALT/AST > 3x ULN

•GFR < 60 ml/min, clinically significant TSH outside normal range

•Lipid-lowering drugs other than statins within 6 months

•Current treatment with pioglitazone, insulin, sulphonylureas, gliptins, glinides, SGLT-2 inhibitors or thiazide diuretics (at a dose of > 25 mg / day)

•Blood pressure > 160 mmHg systolic and/or > 105 diastolic

•History of pancreatitis or stomach / other major bleeding, thyroid neoplasia, persistent hypothyroidism or persistent hyperthyroidism

•Any medical condition that puts the patient in the risk of dehydration

•Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.

•Females of childbearing potential who are not using adequate contraceptive methods

•Subjects who have experienced side-effects previously from GLP-1 agonists

•Non-compliance or withdrawal of consent

•Any information or clinical event described in liraglutide SPC that is a contraindication for the use of liraglutide

Endpoints (42)

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

Cardiometabolic biomarkers

Glycemic / diabetes

Weight & body composition

MASH / liver

Other (unclassified)

Weight & body composition

6 endpoints

Primary/registry result

Body Weight

Time frame:Baseline and after 16 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
LiraglutideBaseline	98.6	—
16 weeks	96.1	—
PlaceboBaseline	92.0	—
16 weeks	89.8	—

p0.002Wilcoxon (Mann-Whitney)

p0.128Wilcoxon (Mann-Whitney)

Primary/registry result

Change in VAT Area

Time frame:Baseline and after 16 weeks

Visceral fat, change

change from baseline, improvement

Posted result

Group	Value (mean), cm3	95% CI
LiraglutideBaseline	3403	—
16 weeks	3185	—
PlaceboBaseline	2710	—
16 weeks	2600	—

p0.047Wilcoxon (Mann-Whitney)

p0.499Wilcoxon (Mann-Whitney)

Primary/registry result

Change in SAT Area

Time frame:Baseline and after 16 weeks

Subcutaneous fat, change

change from baseline, improvement

Posted result

Group	Value (mean), cm3	95% CI
LiraglutideBaseline	4043	—
16 weeks	3792	—
PlaceboBaseline	5400	—
16 weeks	5161	—

p0.004Wilcoxon (Mann-Whitney)

p0.128Wilcoxon (Mann-Whitney)

Primary/protocol endpoint

Body Weight

Time frame:Baseline and after 16 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Primary/protocol endpoint

Change in VAT Area

Time frame:Baseline and after 16 weeks

Visceral fat, change

change from baseline, improvement

Primary/protocol endpoint

Change in SAT Area

Time frame:Baseline and after 16 weeks

Subcutaneous fat, change

change from baseline, improvement

Glycemic / diabetes

8 endpoints

Primary/registry result

Change in HbA1c Level

Time frame:Baseline and after 16 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), HbA1c %	95% CI
LiraglutideBaseline	7.0	—
16 weeks	6.4	—
PlaceboBaseline	6.3	—
16 weeks	6.4	—

p0.005Wilcoxon (Mann-Whitney)

p0.343Wilcoxon (Mann-Whitney)

Primary/registry result

Change in fP-glucose Level

Time frame:Baseline and after 16 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
LiraglutideBaseline	8.3	—
16 weeks	6.4	—
PlaceboBaseline	6.5	—
16 weeks	6.4	—

p0.001Wilcoxon (Mann-Whitney)

p0.865Wilcoxon (Mann-Whitney)

Primary/registry result/low confidence

Change in Insulin Level

Time frame:Baseline and after16 weeks

change from baseline, improvement

Posted result

Group	Value (mean), μU/mL	95% CI
LiraglutideBaseline	13.9	—
16 weeks	14.5	—
PlaceboBaseline	13.8	—
16 weeks	14.1	—

p0.532Wilcoxon (Mann-Whitney)

p0.735Wilcoxon (Mann-Whitney)

Primary/registry result

Change in Matsuda Index

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Posted result

Group	Value (mean), index	95% CI
LiraglutideBaseline	2.5	—
16 weeks	3.5	—
PlaceboBaseline	3.1	—
16 weeks	3.1	—

p0.017Wilcoxon (Mann-Whitney)

p0.753Wilcoxon (Mann-Whitney)

Primary/protocol endpoint

Change in HbA1c Level

Time frame:Baseline and after 16 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Change in fP-glucose Level

Time frame:Baseline and after 16 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Primary/protocol endpoint

Change in Insulin Level

Time frame:Baseline and after16 weeks

change from baseline, improvement

Primary/protocol endpoint

Change in Matsuda Index

Time frame:Baseline and after 16 weeks

change from baseline, improvement

MASH / liver

4 endpoints

Primary/registry result

Change in Liver Fat Content

Time frame:Baseline and after 16 weeks

Liver fat content, change

change from baseline, improvement

Posted result

Group	Value (mean), fat %	95% CI
LiraglutideBaseline	14.8	—
16 weeks	10.7	—
PlaceboBaseline	16.1	—
16 weeks	13.9	—

p0.001Wilcoxon (Mann-Whitney)

p0.028Wilcoxon (Mann-Whitney)

Primary/protocol endpoint

Change in Liver Fat Content

Time frame:Baseline and after 16 weeks

Liver fat content, change

change from baseline, improvement

Secondary/registry result/low confidence

Change in Hepatic de Novo Lipogenesis

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Posted result

Group	Value (mean), μmol/L	95% CI
LiraglutideBaseline	15.4	—
16 weeks	19.1	—
PlaceboBaseline	12.6	—
16 weeks	13.8	—

p0.152Wilcoxon (Mann-Whitney)

p0.866Wilcoxon (Mann-Whitney)

Secondary/protocol endpoint

Change in Hepatic de Novo Lipogenesis

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Cardiometabolic biomarkers

23 endpoints

Primary/registry result

Plasma Triglyceride (TG) Area Under Curve (AUC)

Time frame:Baseline and after 16 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (mean), mmol/l per h	95% CI
LiraglutideBaseline	22.0	—
16 weeks	17.1	—
PlaceboBaseline	17.5	—
16 weeks	19.0	—

p0.011Wilcoxon (Mann-Whitney)

p0.612Wilcoxon (Mann-Whitney)

Primary/registry result

Change in ApoCIII Level

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
LiraglutideBaseline	12.0	—
16 weeks	9.9	—
PlaceboBaseline	9.7	—
16 weeks	8.6	—

p0.018Wilcoxon (Mann-Whitney)

p0.578Wilcoxon (Mann-Whitney)

Primary/protocol endpoint

Plasma Triglyceride (TG) Area Under Curve (AUC)

Time frame:Baseline and after 16 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/registry result

Change in Systolic RR

Time frame:Baseline and after 16 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mm Hg	95% CI
LiraglutideBaseline	135	—
16 weeks	139	—
PlaceboBaseline	145	—
16 weeks	137	—

p0.173Wilcoxon (Mann-Whitney)

p0.018Wilcoxon (Mann-Whitney)

Secondary/registry result/low confidence

Mean Total Production of apoB48

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Posted result

Group	Value (mean), mg/day	95% CI
LiraglutideBaseline	490	—
16 weeks	329	—
PlaceboBaseline	570	—
16 weeks	530	—

p0.002Wilcoxon (Mann-Whitney)

p1Wilcoxon (Mann-Whitney)

Secondary/registry result

Mean Production Rate of apoB48 in CM

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Posted result

Group	Value (mean), mg/day	95% CI
LiraglutideBaseline	284	—
16 weeks	113	—
PlaceboBaseline	190	—
16 weeks	160	—

p<0.001Wilcoxon (Mann-Whitney)

p0.79Wilcoxon (Mann-Whitney)

Secondary/registry result

Mean apoB48 FTR to VLDL1 Particles

Time frame:Baseline and after 16 weeks

change from baseline, descriptive

Posted result

Group	Value (mean), pools/day	95% CI
LiraglutideBaseline	12	—
16 weeks	26	—
PlaceboBaseline	34	—
16 weeks	30	—

p<0.001Wilcoxon (Mann-Whitney)

p0.13Wilcoxon (Mann-Whitney)

Secondary/registry result/low confidence

Mean TG Fractional Catabolic Rates in CM

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Posted result

Group	Value (mean), pools/day	95% CI
LiraglutideBaseline	33	—
16 weeks	46	—
PlaceboBaseline	64	—
16 weeks	59	—

p0.011Wilcoxon (Mann-Whitney)

p0.13Wilcoxon (Mann-Whitney)

Secondary/registry result/low confidence

Mean CM FDC of apoB48

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Posted result

Group	Value (mean), pools/day	95% CI
LiraglutideBaseline	9	—
16 weeks	0.8	—
PlaceboBaseline	4.4	—
16 weeks	3.2	—

p<0.001Wilcoxon (Mann-Whitney)

p0.13Wilcoxon (Mann-Whitney)

Secondary/registry result

Change in Direct CM-apoB48 Clearance

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Posted result

Group	Value (mean), mg/day	95% CI
LiraglutideBaseline	106	—
16 weeks	3.8	—
PlaceboBaseline	20	—
16 weeks	17	—

p<0.001Wilcoxon (Mann-Whitney)

p0.79Wilcoxon (Mann-Whitney)

Secondary/registry result/low confidence

Mean CM-apoB48 Transfer Rates to VLDL1

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Posted result

Group	Value (mean), mg/day	95% CI
LiraglutideBaseline	127	—
16 weeks	110	—
PlaceboBaseline	170	—
16 weeks	150	—

p0.017Wilcoxon (Mann-Whitney)

p0.79Wilcoxon (Mann-Whitney)

Secondary/registry result

Mean VLDL1-TG Production Rates

Time frame:Baseline and after16 weeks

VLDL, change

change from baseline, improvement

Posted result

Group	Value (mean), g/day	95% CI
LiraglutideBaseline	51	—
16 weeks	35	—
PlaceboBaseline	43	—
16 weeks	35	—

p0.017Wilcoxon (Mann-Whitney)

p0.18Wilcoxon (Mann-Whitney)

Secondary/registry result

Mean Fractional Catabolic Rate of VLDL2-apoB100

Time frame:Baseline and after 16 weeks

change from baseline, descriptive

Posted result

Group	Value (mean), pools/day	95% CI
LiraglutideBaseline	6.7	—
16 weeks	5.6	—
PlaceboBaseline	4.5	—
16 weeks	5.1	—

p0.068Wilcoxon (Mann-Whitney)

p0.63Wilcoxon (Mann-Whitney)

Secondary/protocol endpoint

Change in Systolic RR

Time frame:Baseline and after 16 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Mean Total Production of apoB48

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Secondary/protocol endpoint

Mean Production Rate of apoB48 in CM

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Secondary/protocol endpoint

Mean apoB48 FTR to VLDL1 Particles

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Mean TG Fractional Catabolic Rates in CM

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Secondary/protocol endpoint

Mean CM FDC of apoB48

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Direct CM-apoB48 Clearance

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Secondary/protocol endpoint

Mean CM-apoB48 Transfer Rates to VLDL1

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Secondary/protocol endpoint

Mean VLDL1-TG Production Rates

Time frame:Baseline and after16 weeks

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Fractional Catabolic Rate of VLDL2-apoB100

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Change in ApoCIII Level

Time frame:Baseline and after 16 weeks

change from baseline, improvement

Publications (6)

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

Effects of liraglutide on the metabolism of triglyceride-rich lipoproteins in type 2 diabetes.
Diabetes, obesity & metabolism2021 May (month)PMID33502078doi:10.1111/dom.14328via CT.gov reference
Investigation of human apoB48 metabolism using a new, integrated non-steady-state model of apoB48 and apoB100 kinetics.
Journal of internal medicine2019 May (month)PMID30779243doi:10.1111/joim.12877via CT.gov reference
Liraglutide treatment improves postprandial lipid metabolism and cardiometabolic risk factors in humans with adequately controlled type 2 diabetes: A single-centre randomized controlled study.
Diabetes, obesity & metabolism2019 Jan (month)PMID30073766doi:10.1111/dom.13487via CT.gov reference
Pioglitazone improves insulin sensitivity among nondiabetic patients with a recent transient ischemic attack or ischemic stroke.
Stroke2003 Jun (month)PMID12730556doi:10.1161/01.STR.0000071108.00234.0Evia CT.gov background
Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp.
Diabetes care1999 Sep (month)PMID10480510doi:10.2337/diacare.22.9.1462via CT.gov background
Kinetic model for production and metabolism of very low density lipoprotein triglycerides. Evidence for a slow production pathway and results for normolipidemic subjects.
The Journal of clinical investigation1979 Jun (month)PMID221537doi:10.1172/JCI109421via CT.gov background

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.