Obesity & OverweightPhase 4NCT07913685
The Effect of Liraglutide on Body Weight, Body Composition, Ectopic Lipid Accumulation and Insulin Sensitivity in Subjects With Overweight or Obesity Without Diabetes
A Phase 4 study testing liraglutide and Low-calorie diet with dietician's monitoring in people with Obesity & Overweight, run by Medical University of Bialystok at 1 site in Poland.
Trial summary
The aim of the study is to evaluate the effect of a 12-week liraglutide treatment as an addition to dietary intervention in comparison to dietary intervention alone on body weight, body composition, ectopic lipid accumulation and insulin sensitivity in subjects with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- liraglutide and Low-calorie diet with dietician's monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 sitePoland
- Study dates
- 5 Apr 2023to 19 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 18 and 60 years (both inclusive)
- body mass index ≥27 kg/m2
- informed oral and written consent
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Bialystok
Bialystok, Podlaskie Voivodeship, 15-276
About this study
Official title: 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
The aim of the study is to evaluate the effect of a 12-week liraglutide treatment as an addition to dietary intervention in comparison to dietary intervention alone on body weight, body composition, ectopic lipid accumulation and insulin sensitivity in subjects with overweight or obesity.
Read the detailed description
Overweight and obesity are associated with an increased risk of metabolic complications and cardiovascular disease, and even moderate weight loss may lead to significant improvement in metabolic profile. The influence of GLP-1 receptor agonists (GLP-1RAs), such as liraglutide, on body weight and body composition, ectopic fat accumulation and insulin sensitivity is not fully elucidated. It is also unclear whether potential beneficial metabolic effects of GLP-1RAs are only weight-loss dependent or are there other mechanisms independent of weight loss. Therefore, the study aims to assess the impact of a 12-week liraglutide treatment on body weight, body composition, ectopic lipid accumulation and insulin sensitivity in subjects with overweight or obesity without diabetes.
The study subjects will be randomly assigned to one of two groups: receiving liraglutide in the maximum dose of 1.8 mg s.c. daily + low calorie diet or receiving low-calorie diet only. The intervention time will be 12 weeks, with control visits and dietary counselling every 4 weeks. Post-intervention visits to assess whether the achieved results are maintained will be performed at 1, 3, and 6 months after completing the intervention.
- Conditions
- Obesity & Overweight
- Being tested
- liraglutide, Low-calorie diet with dietician's monitoring
- Keywords
- liraglutide, insulin sensitivity, weight loss, overweight, obesity, body composition, ectopic lipid accumulation
- Medical subject headings
- Obesity, Overweight, Insulin Resistance, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
Liraglutide dosing:
- Week 1: 0.6 mg once daily
- Week 2: 1.2 mg once daily
- Weeks 3-12: 1.8 mg once daily
Low-calorie diet with dietician's monitoringOther
Low glycemic index diet with a deficit of 500 kcal/day in relation to the participant's individual total daily energy expenditure. The nutrient goals for the diet are established at 45% energy from carbohydrates, 30% from fat, and 25% from protein. All participants will receive detailed guidelines and personalized menus for each day of the intervention before the start and every 4 weeks during the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide+low-calorie diet | Experimental | Liraglutide administered once daily s.c. + low-calorie diet Duration: 12 weeks Receives: Drug: liraglutide; Other: Low-calorie diet with dietician's monitoring |
| Low-calorie diet | Active comparator | Low-calorie diet Duration: 12 weeks Receives: Other: Low-calorie diet with dietician's monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight (kg)
Observed change in body weight from baseline to week 12 in the group treated with liraglutide+LCD compared to dietary intervention alone.
Measured: Week 12
Secondary outcomes (24)
Proportion of subjects losing ≥ 5% of baseline body weight
Percentage of subjects losing at least 5% of baseline body weight after 12 weeks of treatment.
Measured: Week 12
Proportion of subjects losing ≥ 10% of baseline body weight
Percentage of subjects losing at least 10% of baseline body weight after 12 weeks of treatment.
Measured: Week 12
Change in waist circumference (cm)
Observed change in waist circumference from baseline to week 12.
Measured: Week 12
Change in insulin sensitivity measured in hyperinsulinemic euglycemic clamp
Observed change in insulin sensitivity measured in hyperinsulinemic euglycemic clamp from baseline to week 12.
Insulin sensitivity will be expressed as whole-body glucose uptake normalized for fat-free mass.
Measured: Week 12
Change in indirect indices of insulin sensitivity: HOMA-IR
Observed change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to week 12.
Measured: Week 12
Change in indirect indices of insulin sensitivity: Matsuda
Observed change in Matsuda index from baseline to week 12.
Measured: Week 12
Change in indirect indices of insulin sensitivity: FLAIS
Observed change in Fasting Laboratory Assessment of Insulin Sensitivity (FLAIS) index from baseline to week 12.
FLAIS is an index of insulin sensitivity, calculated from RBC count, ALT, C-peptide, SHBG, adiponectin and IGFBP-1. Higher values of FLAIS reflect higher insulin sensitivity.
Measured: Week 12
Change in body composition: total fat mass (kg)
Observed change in total fat mass measured in dual-energy X-ray absorptiometry (DEXA) from baseline to week 12.
Measured: Week 12
Change in body composition: total lean mass (kg)
Observed change in total lean mass measured in dual-energy X-ray absorptiometry (DEXA) from baseline to week 12.
Measured: Week 12
Change in body composition: visceral adipose tissue mass (g)
Observed change in visceral adipose tissue mass measured in dual-energy X-ray absorptiometry (DEXA) from baseline to week 12.
Measured: Week 12
Change in body composition: subcutaneous adipose tissue mass (g)
Observed change in subcutaneous adipose tissue mass measured in dual-energy X-ray absorptiometry (DEXA) from baseline to week 12.
Measured: Week 12
Change in liver steatosis: CAP
Observed change in liver steatosis expressed as controlled attenuation parameter (CAP) measured with noninvasive transient elastography from baseline to week 12.
Measured: Week 12
Change in intrahepatic lipid content measured with proton magnetic resonance spectroscopy (%)
Observed change in intrahepatic lipid content measured with 1.5 T proton magnetic resonance spectroscopy from baseline to week 12.
Measured: Week 12
Change in intramuscular lipid content measured in proton magnetic resonance spectroscopy (%)
Observed change in intramuscular lipid content measured with 1.5 T proton magnetic resonance spectroscopy from baseline to week 12.
Measured: Week 12
Change in cytokine concentrations
Observed change in the concentrations of pro- and anti-inflammatory cytokines, adhesion molecules, endothelial markers and adipokines from baseline to week 12.
Measured: Week 12
Change in gene expression
Observed change in the expression of genes associated with insulin signaling and inflammation in peripheral blood mononuclear cells assessed with qPCR/NGS from baseline to week 12.
Measured: Week 12
Change in resting energy expenditure
Observed change in resting energy expenditure measured in indirect calorimetry from baseline to week 12.
Measured: Week 12
Change in Beck Depression Inventory score (BDI)
Observed change in depressive symptoms assessed using BDI from baseline to week 12.
Total score: 0-63 points; higher scores reflect greater severity of depressive symptoms.
Measured: Week 12
Change in Hospital Anxiety and Depression Scale (HADS)
Observed change in depressive and anxiety symptoms assessed with HADS from baseline to week 12.
Total score: 0-42 points; higher scores reflect greater severity of depressive and anxiety symptoms.
Measured: Week 12
Change in Montreal Cognitive Assessment (MoCA) score
Observed mean change in cognitive function assessed with MoCA from baseline to week 12.
Total score: 0-30 points; 26 points or higher is considered a normal result.
Measured: Week 12
Change in Short Form 36 Health Survey (SF-36)
Observed mean change in functional status, well-being, and overall evaluation of health assessed with SF-36 from baseline to week 12.
36 questions and standardized response choices, organized into eight multi-item scales. All raw scale scores are converted to a 0 - 100 scale, with higher scores indicating higher levels of functioning or well-being.
Measured: Week 12
Change in body weight (kg) after treatment completion
Observed mean change in body weight from week 12 (end of intervention) to week 24.
Measured: Week 24
Change in HOMA-IR after treatment completion
Observed mean change in HOMA-IR from week 12 (end of intervention) to week 24.
Measured: Week 24
Change in FLAIS after treatment completion
Observed mean change in FLAIS from week 12 (end of intervention) to week 24.
FLAIS is an index of insulin sensitivity, calculated from RBC count, ALT, C-peptide, SHBG, adiponectin and IGFBP-1. Higher values of FLAIS reflect higher insulin sensitivity.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start5 Apr 2023
- Primary completion9 Sep 2025
- Study completion19 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monika Karczewska-Kupczewska, Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913685
- Sponsor's protocol ID
- APK.002.82.2023
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07913685
- Acronym / sponsor ID
- APK.002.82.2023
- Conditions
- Obesity & Overweight
- Keywords
- liraglutide, insulin sensitivity, weight loss, overweight, obesity, body composition, ectopic lipid accumulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 9 Sep 2025 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate the effect of a 12-week liraglutide treatment as an addition to dietary intervention in comparison to dietary intervention alone on body weight, body composition, ectopic lipid accumulation and insulin sensitivity in subjects with overweight or obesity.
Detailed description
Overweight and obesity are associated with an increased risk of metabolic complications and cardiovascular disease, and even moderate weight loss may lead to significant improvement in metabolic profile. The influence of GLP-1 receptor agonists (GLP-1RAs), such as liraglutide, on body weight and body composition, ectopic fat accumulation and insulin sensitivity is not fully elucidated. It is also unclear whether potential beneficial metabolic effects of GLP-1RAs are only weight-loss dependent or are there other mechanisms independent of weight loss. Therefore, the study aims to assess the impact of a 12-week liraglutide treatment on body weight, body composition, ectopic lipid accumulation and insulin sensitivity in subjects with overweight or obesity without diabetes.
The study subjects will be randomly assigned to one of two groups: receiving liraglutide in the maximum dose of 1.8 mg s.c. daily + low calorie diet or receiving low-calorie diet only. The intervention time will be 12 weeks, with control visits and dietary counselling every 4 weeks. Post-intervention visits to assess whether the achieved results are maintained will be performed at 1, 3, and 6 months after completing the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide+low-calorie diet | Experimental | Drug: liraglutide, Other: Low-calorie diet with dietician's monitoringLiraglutide administered once daily s.c. + low-calorie diet Duration: 12 weeks |
| Low-calorie diet | Active comparator | Other: Low-calorie diet with dietician's monitoringLow-calorie diet Duration: 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 18 and 60 years (both inclusive)
- body mass index ≥27 kg/m2
- informed oral and written consent
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutideLiraglutide dosing: * Week 1: 0.6 mg once daily * Week 2: 1.2 mg once daily * Weeks 3-12: 1.8 mg once daily | Drug | Liraglutide+low-calorie diet |
| Low-calorie diet with dietician's monitoringLow glycemic index diet with a deficit of 500 kcal/day in relation to the participant's individual total daily energy expenditure. The nutrient goals for the diet are established at 45% energy from carbohydrates, 30% from fat, and 25% from protein. All participants will receive detailed guidelines and personalized menus for each day of the intervention before the start and every 4 weeks during the intervention. | Other | Liraglutide+low-calorie diet, Low-calorie diet |
Primary outcome
Change in body weight (kg)
Time frame: Week 12
Observed change in body weight from baseline to week 12 in the group treated with liraglutide+LCD compared to dietary intervention alone.
24 secondary outcomes
Proportion of subjects losing ≥ 5% of baseline body weight
Time frame: Week 12
Proportion of subjects losing ≥ 10% of baseline body weight
Time frame: Week 12
Change in waist circumference (cm)
Time frame: Week 12
Change in insulin sensitivity measured in hyperinsulinemic euglycemic clamp
Time frame: Week 12
Change in indirect indices of insulin sensitivity: HOMA-IR
Time frame: Week 12
Change in indirect indices of insulin sensitivity: Matsuda
Time frame: Week 12
Change in indirect indices of insulin sensitivity: FLAIS
Time frame: Week 12
Change in body composition: total fat mass (kg)
Time frame: Week 12
Change in body composition: total lean mass (kg)
Time frame: Week 12
Change in body composition: visceral adipose tissue mass (g)
Time frame: Week 12
Change in body composition: subcutaneous adipose tissue mass (g)
Time frame: Week 12
Change in liver steatosis: CAP
Time frame: Week 12
Change in intrahepatic lipid content measured with proton magnetic resonance spectroscopy (%)
Time frame: Week 12
Change in intramuscular lipid content measured in proton magnetic resonance spectroscopy (%)
Time frame: Week 12
Change in cytokine concentrations
Time frame: Week 12
Change in gene expression
Time frame: Week 12
Change in resting energy expenditure
Time frame: Week 12
Change in Beck Depression Inventory score (BDI)
Time frame: Week 12
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Week 12
Change in Montreal Cognitive Assessment (MoCA) score
Time frame: Week 12
Change in Short Form 36 Health Survey (SF-36)
Time frame: Week 12
Change in body weight (kg) after treatment completion
Time frame: Week 24
Change in HOMA-IR after treatment completion
Time frame: Week 24
Change in FLAIS after treatment completion
Time frame: Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing liraglutide and Low-calorie diet with dietician's monitoring in people with Obesity & Overweight, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (kg) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.