A Phase 4 interventional study of liraglutide and Low-calorie diet with dietician's monitoring in Obesity & Overweight, sponsored by Medical University of Bialystok. Completed at 1 site in Poland. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Medical University of Bialystok · Phase 4, Interventional, and Treatment
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 83 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Medical University of Bialystok is the lead sponsor of 72 studies on the registry; 18 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Liraglutide administered once daily s.c. + low-calorie diet Duration: 12 weeks
Drug: liraglutide · Other: Low-calorie diet with dietician's monitoring
Low-calorie diet Duration: 12 weeks
Other: Low-calorie diet with dietician's monitoring
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 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.
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.
Time frame: Week 12
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.
Time frame: 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.
Time frame: Week 12
Change in waist circumference (cm)
Observed change in waist circumference from baseline to week 12.
Time frame: 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.
Time frame: 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.
Time frame: Week 12
Change in indirect indices of insulin sensitivity: Matsuda
Observed change in Matsuda index from baseline to week 12.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 12
Change in resting energy expenditure
Observed change in resting energy expenditure measured in indirect calorimetry from baseline to week 12.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 24
Change in HOMA-IR after treatment completion
Observed mean change in HOMA-IR from week 12 (end of intervention) to week 24.
Time frame: 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.
Time frame: Week 24
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liraglutide
Medical University of Bialystok