ObesityPhase 4NCT04046822
Effect of Liraglutide on Microbiome in Obesity
A Phase 4 study testing Liraglutide 6 MG/ML [Saxenda] in people with Obesity and Weight Loss, run by Federico II University at 1 site in Italy.
Trial summary
The purpose of the trial is to assess whether the beneficial effect of liraglutide on weight is mediated by changes in the composition of the intestinal Microbiome. The main mechanisms of action of liraglutide were traced to a reduction in the secretion of glucagon and slowing gastric emptying resulting in decreased… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Weight Loss, Microbiome
- What is being tested?
- Liraglutide 6 MG/ML [Saxenda]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jan 2019to 30 Apr 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial;
- Age ≥ 18 years and < 65 years at the time of signing informed consent;
- Body mass index (BMI) ≥ 30 kg/m2
- Stable body weight during the previous 3 months (< 5 kg self-reported weight change).
Who cannot join
- General Safety
- Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial;
- Current use or use within three months before this trial of GLP-1 receptor agonist, pramlintide, sibutramine, orlistat, zonisamide, topiramate or phentermine;
- Type 1 diabetes;
- Type 2 diabetes;
- Obesity related to endocrine diseases;
Show all 30Show fewer
- Hepatic Failure (AST and/or ALT >3 times upper limit of normal and/or Total Bilirubin >1.7 upper limit of normal)
- End stage renal disease (eGFR < 30 ml/min/1.73 m2 ) or chronic or intermittent haemodialysis or peritoneal dialysis
- History or presence of chronic pancreatitis
- Presence of acute pancreatitis within the past 180 days prior to the day of screening
- Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- Presence or history of malignant neoplasms within the past 5 years prior to the day of screening
- Severe psychiatric disorder which in the investigator's opinion could compromise compliance with the protocol
- Known or suspected hypersensitivity to trial product(s) or related products
- Previous participation in this trial. Participation is defined as randomisation
- Receipt of any investigational medicinal product within 30 days before screening
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method i.e.:
- patients who use combined hormonal contraceptives (containing estreogen and progesterone) associated with inhibition of ovulation or oral, intravaginal that transdermal;
- patients who use hormonal contraceptives based only progesterone that inhibit ovulation, whether oral, injectable or implantable
- patients with placement of IUD (intrauterine device)
- patients with positioning of hormone releasing intrauterine systems
- patients with bilateral tubal occlusion
- patients with vasectomized partner
- patients who practice sexual abstinence
- Any disorder, unwillingness or inability, which in the investigator's opinion, might jeopardise the subject's safety or compliance with the protocol
- Previous surgical treatment for obesity (excluding liposuction >1 year before trial entry); 19 ) Inflammatory bowel diseases; 20 ) recent antibiotic therapy ( within 30 days before screening)
- Cardiovascular- related
- Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening;
- Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
"Federico II" University of Naples, Department of Clinical and Molecular Endocrinology and Oncology
Naples, 80131
Annamaria Colao, 00390817462132, colao@unina.it
About this study
Official title: Could Gut Microbiome Contribute to the Therapeutic Effect of Liraglutide 3.0 mg? A Randomized Double Blind Placebo Controlled Trial
The purpose of the trial is to assess whether the beneficial effect of liraglutide on weight is mediated by changes in the composition of the intestinal Microbiome. The main mechanisms of action of liraglutide were traced to a reduction in the secretion of glucagon and slowing gastric emptying resulting in decreased appetite and body weight. It also seems that liraglutide is capable of increasing the satiety signals thanks to a dual mechanism of stimulation and inhibition induced by medication. Pomc neurons (opiomelacortin) present in hypothalamic arcuate nuclei, stimulated by liraglutide, glucagon-like peptide- 1 (GLP-1) receptor expressed by inhibiting intensely appetite. At the same time through the GABAergic neuronal activity is inhibited neuropeptide Y(NPY) deputies to the production of orexins that are powerful promoters of appetite. Alterations in the composition of the human gut microbiome occur in metabolic disorders such as obesity, diabetes. Liraglutide has been reported to switch microbiome composition towards lean-related bacterial phylotypes in animal studies. This leads to hypothesize that the switch of microbiome by liraglutide may be one of the mechanisms through which liraglutide may exert its effect. In particular the investigators hypothesize that liraglutide could restore a healthy microbiome or at least improve the microbiome composition through slowing gastrointestinal motility. Moreover, the liraglutide-related change of microbiome could be an additional mechanism that contribute to the beneficial metabolic effect of liraglutide. To test this hypothesis the investigators will investigate if there will be any change of gut microbiome assessed as Firmicutes-to-Bacteroidetes ratio after liraglutide treatment. In order to understand if the change of gut microbiome after liraglutide treatment occurs as an association or contributes to the effect of liraglutide ,the investigators will correlate the Firmicutes-to-Bacteroidetes ratios with the changes of Body Mass Index, Body Composition, appetite parameters, chronic inflammation parameters, lipid profile and insulin resistance. All the subjects will follow the same diet in order to avoid any bias.
Read the detailed description
This is a randomized, double-blind, parallel group, placebo-controlled trial comparing liraglutide 3.0 mg with placebo both administered subcutaneously once-daily in subjects with established obesity. Subjects will be randomised in a 1:1 ratio to receive either liraglutide 3.0 mg or placebo as an adjunct to standard-of-care.All baseline assessments will be done prior to administration of the first dose of trial product while all the follow up assessments will be done at the end of the trial. Dose escalation of liraglutide/placebo will take place during the first 4 weeks after randomisation as described. All subjects will aim at reaching the recommended target dose of 3.0 mg liraglutide once-daily or the corresponding volume of placebo. In this trial approximately 70 subjects will be randomly assigned to trial product.
- Conditions
- Obesity, Weight Loss, Microbiome
- Being tested
- Liraglutide 6 MG/ML [Saxenda], Placebo
- Keywords
- obesity, liraglutide, gut microbiome
- Medical subject headings
- Obesity, Weight Loss
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
Also called Saxenda
Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
PlaceboDrug
Also called Saline Injection
Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Active drug | Active comparator | Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day. Receives: Drug: Liraglutide 6 MG/ML [Saxenda] |
| Placebo | Placebo comparator | Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gut microbiome composition assessed by Firmicutes-to-Bacteroidetes ratio using Quantitative polymerase chain reaction (PCR)
The liraglutide treatment effect on gut microbiome composition quantified as Firmicutes-to-Bacteroidetes ratio by Quantitative polymerase chain reaction (PCR)
Measured: Change from baseline in gut microbiome composition at weeks 5 (visit 7)
Secondary outcomes (20)
Change in body weight (kg) assessed by scale
The liraglutide treatment effect on weight ( kg) assessed by scale
Measured: Change from baseline in body weight at weeks 5 (visit 7)
Change in body weight (kg) that will be combined with height (m) to report BMI (kg/m^2) where kg is a person's weight in kilograms and m2 is a person's height in metres squared
The liraglutide treatment effect on body weight (kg) that will be combined with height (m) to report BMI (kg/m^2) where kg is a person's weight in kilograms and m2 is a person's height in metres squared
Measured: Change from baseline in body mass index at weeks 5 (visit 7)
Change in body composition assessed by Bioelectrical impedance analysis (BIA)
The liraglutide treatment effect on body composition assessed by BIA
Measured: Change from baseline in body composition at weeks 5 (visit 7)
Change in hormonal regulation of appetite assessed by ghrelin levels
The liraglutide treatment effect on hormonal regulation of appetite assessed by ghrelin levels
Measured: Change from baseline in ghrelin levels at weeks 5 (visit 7)
Change in hormonal regulation of hunger suppression assessed by cholecystokinin levels
The liraglutide treatment effect on hormonal regulation of hunger suppression assessed by cholecystokinin levels
Measured: Change from baseline in cholecystokinin levels at weeks 5 (visit 7)
Change in hormonal regulation of appetite assessed by polipeptide YY levels
The liraglutide treatment effect on hormonal regulation of appetite assessed by polipeptide YY levels
Measured: Change from baseline in polipeptide YY levels at weeks 5 (visit 7)
Change in hormonal regulation of weight assessed by leptin levels
The liraglutide treatment effect on hormonal regulation of weight assessed by leptin levels
Measured: Change from baseline in leptin levels at weeks 5 (visit 7)
Change in low grade inflammation assessed by C-reactive protein levels
The liraglutide treatment effect on low grade inflammation assessed by C-reactive protein levels
Measured: Change from baseline in C-reactive protein levels at weeks 5 (visit 7)
Change in low grade inflammation assessed by erythrocyte sedimentation rate (ESR) levels
The liraglutide treatment effect on low grade inflammation assessed by ESR levels
Measured: Change from baseline in ESR levels at weeks 5 (visit 7)
Change in low grade inflammation assessed by interleukin- 1 (IL- 1) levels
The liraglutide treatment effect on low grade inflammation assessed by IL- 1 levels
Measured: Change from baseline in IL- 1 levels at weeks 5 (visit 7)
Change in low grade inflammation assessed by interleukin- 6 (IL- 6) levels
The liraglutide treatment effect on low grade inflammation assessed by IL- 6 levels
Measured: Change from baseline in IL- 6 levels at weeks 5 (visit 7)
Change in low grade inflammation assessed by interleukin- 10 (IL- 10) levels
The liraglutide treatment effect on low grade inflammation assessed by IL- 10 levels
Measured: Change from baseline in IL- 10 levels at weeks 5 (visit 7)
Change in low grade inflammation assessed by Tumor Necrosis Factor -α (TNF-α) levels
The liraglutide treatment effect on low grade inflammation assessed by TNF-α levels
Measured: Change from baseline in TNF-α levels at weeks 5 (visit 7)
Change in low grade inflammation assessed by monocyte chemotactic protein - 1 (MCP-1) levels
The liraglutide treatment effect on low grade inflammation assessed by MCP-1 levels
Measured: Change from baseline in MCP-1 levels at weeks 5 (visit 7)
Change in lipid profile assessed by total cholesterol levels
The liraglutide treatment effect on lipid profile assessed by total cholesterol levels
Measured: Change from baseline in total cholesterol levels at weeks 5 (visit 7)
Change in lipid profile assessed by LDL cholesterol levels
The liraglutide treatment effect on lipid profile assessed by LDL cholesterol levels
Measured: Change from baseline in LDL cholesterol levels at weeks 5 (visit 7)
Change in lipid profile assessed by HDL cholesterol levels
The liraglutide treatment effect on lipid profile assessed by HDL cholesterol levels
Measured: Change from baseline in HDL cholesterol levels at weeks 5 (visit 7)
Change in lipid profile assessed by triglycerides levels
The liraglutide treatment effect on lipid profile assessed by triglycerides levels
Measured: Change from baseline in triglycerides levels at weeks 5 (visit 7)
Change in insulin resistance assessed by Matsuda Index
The liraglutide treatment effect on insulin resistance assessed by Matsuda Index
Measured: Change from baseline in insulin resistance assessed by Matsuda Index at weeks 5 (visit 7)
Change in insulin resistance assessed by homeostasis model assessment - insulin resistance (HOMA-IR) Index
The liraglutide treatment effect on insulin resistance assessed by HOMA-IR Index
Measured: Change from baseline in insulin resistance assessed by HOMA-IR Index at weeks 5 (visit 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start9 Jan 2019
- Primary completion9 Jan 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annamaria Colao, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046822
- Sponsor's protocol ID
- Microbiome 1
- Status last verified
- Aug 2019
- First submitted
- 8 Jul 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eckburg PB, Bik EM, Bernstein CN, Purdom E, Dethlefsen L, Sargent M, Gill SR, Nelson KE, Relman DA. Diversity of the human intestinal microbial flora. Science. 2005 Jun 10;308(5728):1635-8. doi: 10.1126/science.1110591. Epub 2005 Apr 14.
PubMed 15831718Patterson E, Ryan PM, Cryan JF, Dinan TG, Ross RP, Fitzgerald GF, Stanton C. Gut microbiota, obesity and diabetes. Postgrad Med J. 2016 May;92(1087):286-300. doi: 10.1136/postgradmedj-2015-133285. Epub 2016 Feb 24.
PubMed 26912499Dinan TG, Cryan JF. Mood by microbe: towards clinical translation. Genome Med. 2016 Apr 6;8(1):36. doi: 10.1186/s13073-016-0292-1.
PubMed 27048547Nakatani Y, Maeda M, Matsumura M, Shimizu R, Banba N, Aso Y, Yasu T, Harasawa H. Effect of GLP-1 receptor agonist on gastrointestinal tract motility and residue rates as evaluated by capsule endoscopy. Diabetes Metab. 2017 Oct;43(5):430-437. doi: 10.1016/j.diabet.2017.05.009. Epub 2017 Jun 23.
PubMed 28648835Backhed F, Ding H, Wang T, Hooper LV, Koh GY, Nagy A, Semenkovich CF, Gordon JI. The gut microbiota as an environmental factor that regulates fat storage. Proc Natl Acad Sci U S A. 2004 Nov 2;101(44):15718-23. doi: 10.1073/pnas.0407076101. Epub 2004 Oct 25.
PubMed 15505215
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Gut Microbiome Contribute to the Therapeutic Effect of Liraglutide 3.0 mg? A Randomized Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04046822
- Acronym / sponsor ID
- Microbiome 1
- Conditions
- Obesity, Weight Loss, Microbiome
- Keywords
- obesity, liraglutide, gut microbiome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 9 Jan 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 6 Aug 2019 (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 purpose of the trial is to assess whether the beneficial effect of liraglutide on weight is mediated by changes in the composition of the intestinal Microbiome. The main mechanisms of action of liraglutide were traced to a reduction in the secretion of glucagon and slowing gastric emptying resulting in decreased appetite and body weight. It also seems that liraglutide is capable of increasing the satiety signals thanks to a dual mechanism of stimulation and inhibition induced by medication. Pomc neurons (opiomelacortin) present in hypothalamic arcuate nuclei, stimulated by liraglutide, glucagon-like peptide- 1 (GLP-1) receptor expressed by inhibiting intensely appetite. At the same time through the GABAergic neuronal activity is inhibited neuropeptide Y(NPY) deputies to the production of orexins that are powerful promoters of appetite. Alterations in the composition of the human gut microbiome occur in metabolic disorders such as obesity, diabetes. Liraglutide has been reported to switch microbiome composition towards lean-related bacterial phylotypes in animal studies. This leads to hypothesize that the switch of microbiome by liraglutide may be one of the mechanisms through which liraglutide may exert its effect. In particular the investigators hypothesize that liraglutide could restore a healthy microbiome or at least improve the microbiome composition through slowing gastrointestinal motility. Moreover, the liraglutide-related change of microbiome could be an additional mechanism that contribute to the beneficial metabolic effect of liraglutide. To test this hypothesis the investigators will investigate if there will be any change of gut microbiome assessed as Firmicutes-to-Bacteroidetes ratio after liraglutide treatment. In order to understand if the change of gut microbiome after liraglutide treatment occurs as an association or contributes to the effect of liraglutide ,the investigators will correlate the Firmicutes-to-Bacteroidetes ratios with the changes of Body Mass Index, Body Composition, appetite parameters, chronic inflammation parameters, lipid profile and insulin resistance. All the subjects will follow the same diet in order to avoid any bias.
Detailed description
This is a randomized, double-blind, parallel group, placebo-controlled trial comparing liraglutide 3.0 mg with placebo both administered subcutaneously once-daily in subjects with established obesity. Subjects will be randomised in a 1:1 ratio to receive either liraglutide 3.0 mg or placebo as an adjunct to standard-of-care.All baseline assessments will be done prior to administration of the first dose of trial product while all the follow up assessments will be done at the end of the trial. Dose escalation of liraglutide/placebo will take place during the first 4 weeks after randomisation as described. All subjects will aim at reaching the recommended target dose of 3.0 mg liraglutide once-daily or the corresponding volume of placebo. In this trial approximately 70 subjects will be randomly assigned to trial product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active drug | Active comparator | Drug: Liraglutide 6 MG/ML [Saxenda]Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial;
- Age ≥ 18 years and < 65 years at the time of signing informed consent;
- Body mass index (BMI) ≥ 30 kg/m2
- Stable body weight during the previous 3 months (< 5 kg self-reported weight change).
Key exclusion criteria (30 listed)
- General Safety
- Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial;
- Current use or use within three months before this trial of GLP-1 receptor agonist, pramlintide, sibutramine, orlistat, zonisamide, topiramate or phentermine;
- Type 1 diabetes;
- Type 2 diabetes;
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]Also: SaxendaLiraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day. | Drug | Active drug |
| PlaceboAlso: Saline InjectionPlacebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day. | Drug | Placebo |
Primary outcome
Change in gut microbiome composition assessed by Firmicutes-to-Bacteroidetes ratio using Quantitative polymerase chain reaction (PCR)
Time frame: Change from baseline in gut microbiome composition at weeks 5 (visit 7)
The liraglutide treatment effect on gut microbiome composition quantified as Firmicutes-to-Bacteroidetes ratio by Quantitative polymerase chain reaction (PCR)
20 secondary outcomes
Change in body weight (kg) assessed by scale
Time frame: Change from baseline in body weight at weeks 5 (visit 7)
Change in body weight (kg) that will be combined with height (m) to report BMI (kg/m^2) where kg is a person's weight in kilograms and m2 is a person's height in metres squared
Time frame: Change from baseline in body mass index at weeks 5 (visit 7)
Change in body composition assessed by Bioelectrical impedance analysis (BIA)
Time frame: Change from baseline in body composition at weeks 5 (visit 7)
Change in hormonal regulation of appetite assessed by ghrelin levels
Time frame: Change from baseline in ghrelin levels at weeks 5 (visit 7)
Change in hormonal regulation of hunger suppression assessed by cholecystokinin levels
Time frame: Change from baseline in cholecystokinin levels at weeks 5 (visit 7)
Change in hormonal regulation of appetite assessed by polipeptide YY levels
Time frame: Change from baseline in polipeptide YY levels at weeks 5 (visit 7)
Change in hormonal regulation of weight assessed by leptin levels
Time frame: Change from baseline in leptin levels at weeks 5 (visit 7)
Change in low grade inflammation assessed by C-reactive protein levels
Time frame: Change from baseline in C-reactive protein levels at weeks 5 (visit 7)
Change in low grade inflammation assessed by erythrocyte sedimentation rate (ESR) levels
Time frame: Change from baseline in ESR levels at weeks 5 (visit 7)
Change in low grade inflammation assessed by interleukin- 1 (IL- 1) levels
Time frame: Change from baseline in IL- 1 levels at weeks 5 (visit 7)
Change in low grade inflammation assessed by interleukin- 6 (IL- 6) levels
Time frame: Change from baseline in IL- 6 levels at weeks 5 (visit 7)
Change in low grade inflammation assessed by interleukin- 10 (IL- 10) levels
Time frame: Change from baseline in IL- 10 levels at weeks 5 (visit 7)
Change in low grade inflammation assessed by Tumor Necrosis Factor -α (TNF-α) levels
Time frame: Change from baseline in TNF-α levels at weeks 5 (visit 7)
Change in low grade inflammation assessed by monocyte chemotactic protein - 1 (MCP-1) levels
Time frame: Change from baseline in MCP-1 levels at weeks 5 (visit 7)
Change in lipid profile assessed by total cholesterol levels
Time frame: Change from baseline in total cholesterol levels at weeks 5 (visit 7)
Change in lipid profile assessed by LDL cholesterol levels
Time frame: Change from baseline in LDL cholesterol levels at weeks 5 (visit 7)
Change in lipid profile assessed by HDL cholesterol levels
Time frame: Change from baseline in HDL cholesterol levels at weeks 5 (visit 7)
Change in lipid profile assessed by triglycerides levels
Time frame: Change from baseline in triglycerides levels at weeks 5 (visit 7)
Change in insulin resistance assessed by Matsuda Index
Time frame: Change from baseline in insulin resistance assessed by Matsuda Index at weeks 5 (visit 7)
Change in insulin resistance assessed by homeostasis model assessment - insulin resistance (HOMA-IR) Index
Time frame: Change from baseline in insulin resistance assessed by HOMA-IR Index at weeks 5 (visit 7)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Background: PubMed 15831718Eckburg PB, Bik EM, Bernstein CN, Purdom E, Dethlefsen L, Sargent M, Gill SR, Nelson KE, Relman DA. Diversity of the human intestinal microbial flora. Science. 2005 Jun 10;308(5728):1635-8. doi: 10.1126/science.1110591. Epub 2005 Apr 14.
- Background: PubMed 26912499Patterson E, Ryan PM, Cryan JF, Dinan TG, Ross RP, Fitzgerald GF, Stanton C. Gut microbiota, obesity and diabetes. Postgrad Med J. 2016 May;92(1087):286-300. doi: 10.1136/postgradmedj-2015-133285. Epub 2016 Feb 24.
- Background: PubMed 27048547Dinan TG, Cryan JF. Mood by microbe: towards clinical translation. Genome Med. 2016 Apr 6;8(1):36. doi: 10.1186/s13073-016-0292-1.
- Background: PubMed 28648835Nakatani Y, Maeda M, Matsumura M, Shimizu R, Banba N, Aso Y, Yasu T, Harasawa H. Effect of GLP-1 receptor agonist on gastrointestinal tract motility and residue rates as evaluated by capsule endoscopy. Diabetes Metab. 2017 Oct;43(5):430-437. doi: 10.1016/j.diabet.2017.05.009. Epub 2017 Jun 23.
- Background: PubMed 15505215Backhed F, Ding H, Wang T, Hooper LV, Koh GY, Nagy A, Semenkovich CF, Gordon JI. The gut microbiota as an environmental factor that regulates fat storage. Proc Natl Acad Sci U S A. 2004 Nov 2;101(44):15718-23. doi: 10.1073/pnas.0407076101. Epub 2004 Oct 25.
- 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.
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] in people with Obesity and Weight Loss, run by Federico II University at 1 site in Italy.
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 4 inclusion and 30 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 20 Aug 2019. 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 Italy. 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. Some participants in this study may receive a placebo. 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 Annamaria Colao, MD (00390817462132, colao@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut microbiome composition assessed by Firmicutes-to-Bacteroidetes ratio using Quantitative polymerase chain reaction (PCR) (time frame: Change from baseline in gut microbiome composition at weeks 5 (visit 7)). 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 NCT04046822, which also lists 5 linked publications.
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 20 Aug 2019.