CompletedPhase 4

The Effect of Liraglutide on Body Weight, Body Composition, Ectopic Lipid Accumulation and Insulin Sensitivity in Subjects With Overweight or Obesity Without Diabetes

The Effect of Liraglutide as an Adjunct to Dietary Intervention on Body Weight, Body Composition, Ectopic Lipid Accumulation and Insulin Sensitivity in Subjects With Overweight or Obesity Without Diabetes

Lead sponsor

Medical University of Bialystok

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight, Prediabetes / glucose intolerance

Eligibility highlights

•BMI ≥27

Primary endpoint

•Body weight (kg)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07913685

Org study IDAPK.002.82.2023

Timeline

Milestones

Study start2023-04-05actual

Primary completion2025-09-09actual

Study completion2026-01-19actual

Study first posted2026-11-03actual

Last update posted2026-11-03actual

Assets

Investigational agents

Liraglutide

Who this study enrolls

Obesity / overweightPrediabetes / glucose intolerance

Who can enroll

Minimum age18 Years

Maximum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•age between 18 and 60 years (both inclusive)

•body mass index ≥27 kg/m2

•informed oral and written consent

Exclusion criteria

•diabetes diagnosed previously or during screening

•chronic inflammatory diseases

•uncontrolled hyperthyroidism or hypothyroidism

•coronary syndromes and heart failure

•malignant neoplasm - current or in the past

•the use of glucose-, weight- and lipid-lowering medications or anti-inflammatory drugs within the past 3 months

•current use of anticoagulative and/or antiplatelet medications

•use of steroids in the past 12 months

•psychiatric disorders and/or current use of antidepressive or antipsychotic medications

•pharmacologic treatment of obesity in the previous 3 months

•chronic kidney or liver failure

•current smoking

•regular high-intensity physical activity

•specific dietary requirements impossible to fit into study plan

•pregnancy and/or breastfeeding

•polycystic ovary syndrome and/or other hormonal disorders, oral contraception, hormone replacement therapy

•alcohol and/or drug abuse

•infections in the previous month - temporary exclusion

Endpoints (25)

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

Other (unclassified)

Glycemic / diabetes

Cardiometabolic biomarkers

MASH / liver

Patient-reported / QoL

Weight & body composition

9 endpoints

Primary/protocol endpoint

Change in body weight (kg)

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Proportion of subjects losing ≥ 5% of baseline body weight

Time frame:Week 12

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of subjects losing ≥ 10% of baseline body weight

Time frame:Week 12

threshold achievement, improvement

Secondary/protocol endpoint

Change in waist circumference (cm)

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in body composition: total fat mass (kg)

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in body composition: total lean mass (kg)

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in body composition: visceral adipose tissue mass (g)

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in body composition: subcutaneous adipose tissue mass (g)

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight (kg) after treatment completion

Time frame:Week 24

change from baseline, improvement

Glycemic / diabetes

5 endpoints

Secondary/protocol endpoint

Change in insulin sensitivity measured in hyperinsulinemic euglycemic clamp

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in indirect indices of insulin sensitivity: HOMA-IR

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in indirect indices of insulin sensitivity: Matsuda

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in indirect indices of insulin sensitivity: FLAIS

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in HOMA-IR after treatment completion

Time frame:Week 24

change from baseline, improvement

MASH / liver

1 endpoint

Secondary/protocol endpoint

Change in liver steatosis: CAP

Time frame:Week 12

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change in intrahepatic lipid content measured with proton magnetic resonance spectroscopy (%)

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in intramuscular lipid content measured in proton magnetic resonance spectroscopy (%)

Time frame:Week 12

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change in Short Form 36 Health Survey (SF-36)

Time frame:Week 12

change from baseline, improvement

Other (unclassified)

7 endpoints

Secondary/protocol endpoint/low confidence

Change in cytokine concentrations

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in gene expression

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in resting energy expenditure

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Beck Depression Inventory score (BDI)

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Hospital Anxiety and Depression Scale (HADS)

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Montreal Cognitive Assessment (MoCA) score

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in FLAIS after treatment completion

Time frame:Week 24

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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 November 5, 2026 snapshot.