ObesityPhase 4NCT04575194
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
A Phase 4 study testing Liraglutide 6 MG/ML [Saxenda] and Naltrexone-Bupropion Combination in people with Obesity and Blood Pressure, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
The aim of the present study is to compare the efficacy of liraglutide vs. naltrexone/bupropion on metabolic and cardiovascular risk markers, weight loss, as well as the postprandial secretion of gastrointestinal hormones involved in hunger and satiety, after a test meal. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Blood Pressure
- What is being tested?
- Liraglutide 6 MG/ML [Saxenda] and Naltrexone-Bupropion Combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 8 Sep 2020to 30 May 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years with BMI ≥ 30 kg / m2 or BMI ≥ 27 kg / m2 in the presence of dyslipidemia or hypertension or obstructive sleep apnea or fatty infiltration or prediabetes.
Who cannot join
- Presence of any clinical contraindications for the administration of liraglutide or bupropion / naltrexone
- Bariatric surgery
- Diabetes type 2
- Active malignancy
- Medication that affects weight (eg corticosteroids, phenothiazines)
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
First Department of Propaedeutic Internal Medicine
Athens, 11527
Alexandros Kokkinos, MD, PhD, 2132061248, rjd@otenet.gr
About this study
Official title: Cardiovascular and Metabolic Effects of Drugs for the Treatment of Obesity
The aim of the present study is to compare the efficacy of liraglutide vs. naltrexone/bupropion on metabolic and cardiovascular risk markers, weight loss, as well as the postprandial secretion of gastrointestinal hormones involved in hunger and satiety, after a test meal. The study will include 40 patients, who will further be divided into two treatment groups (20 patients on liraglutide vs. 20 patients on naltrexone/bupropion). The patients will be examined at baseline, 3 and 6 months after the treatment initiation.
Read the detailed description
This is a prospective study of patients aged ≥18 years, who are overweight (BMI ≥ 27 kg / m2 in the presence of dyslipidemia or hypertension or obstructive sleep apnea or fatty infiltration or prediabetes) or obese patients (BMI ≥ 30 kg / m2). Patients' data will be collected before starting medication (time 0) and at 3 and 6 months under treatment in the clinical practice of the selected drug, as described in the drug's package leaflet, along with a simultaneous dietary intervention and exercise. Patient groups will be comparable in age, gender and BMI.
The aim of the study is the comparison of the efficacy of liraglutide vs. naltrexone/bupropion in metabolic and cardiovascular markers.
The following parameters will be measured:
- Weight, height, waist and hip circumference
- 24-hour recording of blood pressure and heart rate
- HbA1c, total cholesterol, LDL, HDL, urine albumin/creatinine ratio
- Bioelectric impedance for determination of total and visceral fat and muscle mass Indirect calorimetry for the determination of resting metabolic rate and total energy expenditure
- Determination of baroreflex sensitivity (BRS) and heart rate variability (HRV) to investigate the function of the autonomic nervous system
- Blood sample test meal at 0, 30, 60, 90, 120, 150 and 180 min to determine insulin concentration and gastrointestinal hormones involved in hunger and satiety with modern indirect calorimetry to determine postprandial thermogenic analog scales (VAS)
- Neuropathy tests
- Assessment of quality of life with the SF-36 questionnaire and assessment of the feeling of hunger and satiety
- Echocardiographic determination of the left systolic and telodiastolic diameter of the left ventricle, cardiac fat and the Tei index at times 0 and 6 months with medication
- Pericardial fat
- Conditions
- Obesity, Blood Pressure
- Being tested
- Liraglutide 6 MG/ML [Saxenda], Naltrexone-Bupropion Combination
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide 6 MG/ML [Saxenda]Drug
3 mg of sc liraglutide daily plus lifestyle intervention
Naltrexone-Bupropion CombinationDrug
32/360 mg of oral lnaltrexone-bupropion daily plus lifestyle intervention
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide 3 mg | Active comparator | Patients will be prescribed sc liraglutide 3 mg/day along with a dietary and physical activity intervention. Receives: Drug: Liraglutide 6 MG/ML [Saxenda] |
| Naltrexone/bupropion 32/360 mg | Active comparator | Patients will be prescribed oral naltrexone/bupropion 32/360 mg/day along with a dietary and physical activity intervention. Receives: Drug: Naltrexone-Bupropion Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood pressure
Blood pressure as assessed by 24-hour recording (numerical scale)
Measured: 3 and 6 months
Secondary outcomes (9)
Weight loss
Percentage of weight lost will be measured by an electronic scale (numerical scale)
Measured: 3 and 6 months
Changes in glycemic
Measurement of HbA1c will be measured biochemically (numerical scale)
Measured: 3 and 6 months
Changes in lipemic profile
Total cholesterol, Triglycerides, LDL-C, HDL-C will be measured biochemically (numerical scale)
Measured: 3 and 6 months
Percentage of visceral fat
Measurement of visceral fat by bioimpedance analysis (numerical scale)
Measured: 3 and 6 months
Fat mass
Measurement of fat mass by bioimpedance analysis (numerical scale)
Measured: 3 and 6 months
Fat free mass
Measurement of fat free mass by bioimpedance analysis (numerical scale)
Measured: 3 and 6 months
Autonomic nervous system function
Measurement of heart rate variability will be measured through Ewing score and Spectral analysis testing (numerical scale)
Measured: 3 and 6 months
Changes in meal induced thermogenesis
Measurement through indirect calorimetry and assessment of changes in Resting Metabolic Rate (RMR) (numerical scale)
Measured: 3 and 6 months
Changes in gut hormones involved in appetite regulation
Measurement in plasma before and after the intervention during a mixed meal test will be measured through ELISA kits (numerical scale)
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start8 Sep 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Athens Medical Center
- Responsible party
- Principal investigator, Alexandros Kokkinos, National and Kapodistrian University of Athens
- Investigators
- Alexandros Kokkinos, MD, PhD, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575194
- Sponsor's protocol ID
- Obesity drugs study
- Status last verified
- Oct 2020
- First submitted
- 30 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stefanakis K, Kokkinos A, Simati S, Argyrakopoulou G, Konstantinidou SK, Kouvari M, Kumar A, Kalra B, Mantzoros CS. Circulating levels of all proglucagon-derived peptides are differentially regulated postprandially by obesity status and in response to high-fat meals vs. high-carbohydrate meals. Clin Nutr. 2023 Aug;42(8):1369-1378. doi: 10.1016/j.clnu.2023.06.026. Epub 2023 Jun 28.
PubMed 37418844
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular and Metabolic Effects of Drugs for the Treatment of Obesity
- ClinicalTrials.gov ID
- NCT04575194
- Acronym / sponsor ID
- Obesity drugs study
- Conditions
- Obesity, Blood Pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- Athens Medical Center
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 5 Oct 2020 (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 present study is to compare the efficacy of liraglutide vs. naltrexone/bupropion on metabolic and cardiovascular risk markers, weight loss, as well as the postprandial secretion of gastrointestinal hormones involved in hunger and satiety, after a test meal. The study will include 40 patients, who will further be divided into two treatment groups (20 patients on liraglutide vs. 20 patients on naltrexone/bupropion). The patients will be examined at baseline, 3 and 6 months after the treatment initiation.
Detailed description
This is a prospective study of patients aged ≥18 years, who are overweight (BMI ≥ 27 kg / m2 in the presence of dyslipidemia or hypertension or obstructive sleep apnea or fatty infiltration or prediabetes) or obese patients (BMI ≥ 30 kg / m2). Patients' data will be collected before starting medication (time 0) and at 3 and 6 months under treatment in the clinical practice of the selected drug, as described in the drug's package leaflet, along with a simultaneous dietary intervention and exercise. Patient groups will be comparable in age, gender and BMI.
The aim of the study is the comparison of the efficacy of liraglutide vs. naltrexone/bupropion in metabolic and cardiovascular markers.
The following parameters will be measured:
- Weight, height, waist and hip circumference
- 24-hour recording of blood pressure and heart rate
- HbA1c, total cholesterol, LDL, HDL, urine albumin/creatinine ratio
- Bioelectric impedance for determination of total and visceral fat and muscle mass Indirect calorimetry for the determination of resting metabolic rate and total energy expenditure
- Determination of baroreflex sensitivity (BRS) and heart rate variability (HRV) to investigate the function of the autonomic nervous system
- Blood sample test meal at 0, 30, 60, 90, 120, 150 and 180 min to determine insulin concentration and gastrointestinal hormones involved in hunger and satiety with modern indirect calorimetry to determine postprandial thermogenic analog scales (VAS)
- Neuropathy tests
- Assessment of quality of life with the SF-36 questionnaire and assessment of the feeling of hunger and satiety
- Echocardiographic determination of the left systolic and telodiastolic diameter of the left ventricle, cardiac fat and the Tei index at times 0 and 6 months with medication
- Pericardial fat
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide 3 mg | Active comparator | Drug: Liraglutide 6 MG/ML [Saxenda]Patients will be prescribed sc liraglutide 3 mg/day along with a dietary and physical activity intervention. |
| Naltrexone/bupropion 32/360 mg | Active comparator | Drug: Naltrexone-Bupropion CombinationPatients will be prescribed oral naltrexone/bupropion 32/360 mg/day along with a dietary and physical activity intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥18 years with BMI ≥ 30 kg / m2 or BMI ≥ 27 kg / m2 in the presence of dyslipidemia or hypertension or obstructive sleep apnea or fatty infiltration or prediabetes.
Key exclusion criteria (5 listed)
- Presence of any clinical contraindications for the administration of liraglutide or bupropion / naltrexone
- Bariatric surgery
- Diabetes type 2
- Active malignancy
- Medication that affects weight (eg corticosteroids, phenothiazines)
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 |
|---|---|---|
| Liraglutide 6 MG/ML [Saxenda]3 mg of sc liraglutide daily plus lifestyle intervention | Drug | Liraglutide 3 mg |
| Naltrexone-Bupropion Combination32/360 mg of oral lnaltrexone-bupropion daily plus lifestyle intervention | Drug | Naltrexone/bupropion 32/360 mg |
Primary outcome
Changes in blood pressure
Time frame: 3 and 6 months
Blood pressure as assessed by 24-hour recording (numerical scale)
9 secondary outcomes
Weight loss
Time frame: 3 and 6 months
Changes in glycemic
Time frame: 3 and 6 months
Changes in lipemic profile
Time frame: 3 and 6 months
Percentage of visceral fat
Time frame: 3 and 6 months
Fat mass
Time frame: 3 and 6 months
Fat free mass
Time frame: 3 and 6 months
Autonomic nervous system function
Time frame: 3 and 6 months
Changes in meal induced thermogenesis
Time frame: 3 and 6 months
Changes in gut hormones involved in appetite regulation
Time frame: 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 37418844Stefanakis K, Kokkinos A, Simati S, Argyrakopoulou G, Konstantinidou SK, Kouvari M, Kumar A, Kalra B, Mantzoros CS. Circulating levels of all proglucagon-derived peptides are differentially regulated postprandially by obesity status and in response to high-fat meals vs. high-carbohydrate meals. Clin Nutr. 2023 Aug;42(8):1369-1378. doi: 10.1016/j.clnu.2023.06.026. Epub 2023 Jun 28.
- Individual participant dataSharing planned: No
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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.
Alexandros Kokkinos, MD, PhD principal investigator
National and Kapodistrian University of Athens
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 6 MG/ML [Saxenda] and Naltrexone-Bupropion Combination in people with Obesity and Blood Pressure, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandros Kokkinos, MD, PhD (+302132061248, rjd@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood pressure (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04575194, which also lists 1 linked publication.
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 8 Oct 2020.