ObesityPhase 4LIRAOBNCT03347890
Reward Mechanisms in Obesity
A Phase 4 study of Obesity, run by Zoltan Pataky at 1 site in Switzerland.
Trial summary
The study aims to investigate the effects of 3.0 mg of liraglutide on reward brain circuits in human obesity and to better understand its effects on weight loss (in patients without diabetes). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- 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 siteSwitzerland
- Study dates
- 5 Mar 2018to 30 Mar 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥ 30 kg/m2 and < 40 kg/m2
- right-handed
- current non-smokers
- with stable body weight (<5% reported change during the previous 3 months)
Who cannot join
- History of any psychiatric, neurological, cardiovascular, renal or liver disease, malignancies, type 1 and type 2 diabetes mellitus
- use of centrally acting medication, glucocorticoides, insulin, orlistat
- any substance abuse
- food allergies
- deficits of smell and taste
- history of pancreatitis
Show all 9Show fewer
- family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma
- pregnancy
- contraindications for fMRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Central Nervous System Effects of Liraglutide® 3.0 mg on Reward Mechanisms in Obese Patients Without Diabetes, in Relation to Food Addiction. A Randomized, Single-centre, Double-blind, Placebo Controlled Clinical Trial.
The study aims to investigate the effects of 3.0 mg of liraglutide on reward brain circuits in human obesity and to better understand its effects on weight loss (in patients without diabetes).
According to the study protocol, 70 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg) or Placebo by pen injector.
Read more
All participants will first undergo a functional Magnetic Resonance Imaging (fMRI) session while being presented with gustatory stimuli. Second, participants will complete behavioural tasks (i.e., liking versus wanting, in the scanner) and questionnaires aiming at teasing apart reward mechanisms and emotional skills (e.g., emotional regulation ability) associated with food intake. Third, metabolic parameters and hormones involved in appetite regulation will be assessed and studied in relation to fMRI.
These measurements will be repeated after 16 weeks in obese individuals. The control group of normal body weight individuals will be evaluated once at Baseline.
- Conditions
- Obesity
- Being tested
- Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or Placebo
- Keywords
- GLP-1, fMRI
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or PlaceboDrug
Patients will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg) or Placebo by pen injector.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide 3.0 mg | Experimental | 35 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg). Receives: Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or Placebo |
| Placebo | Placebo comparator | 35 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Placebo by pen injector. Receives: Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Bold Oxygenation Level Dependent (BOLD) signal (%) in brain regions involved in the reward system
Bold changes in striatum, amygdala, insula, orbitofrontal complex as detected by fMRI in from baseline to 16-week follow-up
Measured: 16 weeks
Secondary outcomes (15)
change of body weight
Weight measurement (kg)
Measured: 16 weeks
changes in waist circumference
waist circumference measurement (cm)
Measured: 16 weeks
changes in fasting blood sugar
fasting glycaemia measurement (mmol/l)
Measured: 16 weeks
changes in glucagon
glucagon measurement (pmol/l)
Measured: 16 weeks
changes in ghrelin
ghrelin measurement (mg/dl)
Measured: 16 weeks
changes in leptin
leptin measurement (ng/ml)
Measured: 16 weeks
changes in obestatin
obestatin measurement (ng/ml)
Measured: 16 weeks
changes in reelin
reelin measurement (ng/microL)
Measured: 16 weeks
changes in endocannabinoids
measurement of anandamide (AEA), 2-arachidonoylglycerol (2-AG), N-palmitoylethanolamide (PEA), N-oleoylethanolamide (OEA); ng/ml for all
Measured: 16 weeks
changes in insulin
fasting insulinaemia measurement (mUI/l)
Measured: 16 weeks
change in food addiction score
Assessment by YFAS V.2 questionnaire, 25 questions, total score is reported
Measured: 16 weeks
change in liking
Assessment by Pavlovian-Instrumental Transfer (PIT) test during fMRI scanning. Participants will taste the milkshake and tasteless solutions and asked to rate them based on how much they liked tasting the stimulus on a visual analogue scale (ranging from 1 "not at all" to 100 "extremely").
Measured: 16 weeks
change in wanting
Assessment by Pavlovian-Instrumental Transfer (PIT) test during fMRI scanning. We will measure the mobilized effort (using a handgrip) the participants mobilized to be delivered with the milkshake.
Measured: 16 weeks
change in emotional regulation abilities
Assessed by an emotional regulation task. Subjects will be presented with neutral, positive, negative, and mixed emotional feelings film clips and asked to either attend naturally or decrease their emotional reactions. The clips will be rated on amusement and repulsion scales on a 6-point scale. Based on these ratings, we will calculate a mixed feelings coefficient.
Measured: 16 weeks
BOLD in brain regions involved in the reward system
BOLD (%) in striatum, amygdala, insula, orbitofrontal complex as detected by fMRI in the obese groups at baseline in comparison to normal body weight controls
Measured: baseline comparison
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start5 Mar 2018
- Primary completion18 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Model description
- Randomized, single-centre, double-blind, placebo controlled, parallel group, clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoltan Pataky
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Responsible party
- Sponsor-investigator, Zoltan Pataky, University Hospital, Geneva
- Investigators
- Zoltan Pataky, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347890
- Sponsor's protocol ID
- 2017-01085
- Other IDs
- U1111-1194-9675, 2017
- Acronym
- LIRAOB
- Status last verified
- Apr 2021
- First submitted
- 12 Nov 2017
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Nervous System Effects of Liraglutide® 3.0 mg on Reward Mechanisms in Obese Patients Without Diabetes, in Relation to Food Addiction. A Randomized, Single-centre, Double-blind, Placebo Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03347890
- Acronym / sponsor ID
- LIRAOB / 2017-01085
- Conditions
- Obesity
- Keywords
- GLP-1, fMRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Zoltan PatakyUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 20 Nov 2017 (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 study aims to investigate the effects of 3.0 mg of liraglutide on reward brain circuits in human obesity and to better understand its effects on weight loss (in patients without diabetes).
According to the study protocol, 70 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg) or Placebo by pen injector.
All participants will first undergo a functional Magnetic Resonance Imaging (fMRI) session while being presented with gustatory stimuli. Second, participants will complete behavioural tasks (i.e., liking versus wanting, in the scanner) and questionnaires aiming at teasing apart reward mechanisms and emotional skills (e.g., emotional regulation ability) associated with food intake. Third, metabolic parameters and hormones involved in appetite regulation will be assessed and studied in relation to fMRI.
These measurements will be repeated after 16 weeks in obese individuals. The control group of normal body weight individuals will be evaluated once at Baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, single-centre, double-blind, placebo controlled, parallel group, clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Liraglutide 3.0 mg | Experimental | Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or Placebo35 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg). |
| Placebo | Placebo comparator | Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or Placebo35 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Placebo by pen injector. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI ≥ 30 kg/m2 and < 40 kg/m2
- right-handed
- current non-smokers
- with stable body weight (<5% reported change during the previous 3 months)
Key exclusion criteria (9 listed)
- History of any psychiatric, neurological, cardiovascular, renal or liver disease, malignancies, type 1 and type 2 diabetes mellitus
- use of centrally acting medication, glucocorticoides, insulin, orlistat
- any substance abuse
- food allergies
- deficits of smell and taste
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 (Saxenda) 6Mg/Ml Inj Pen 3Ml or PlaceboPatients will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg) or Placebo by pen injector. | Drug | Liraglutide 3.0 mg, Placebo |
Primary outcome
Change of Bold Oxygenation Level Dependent (BOLD) signal (%) in brain regions involved in the reward system
Time frame: 16 weeks
Bold changes in striatum, amygdala, insula, orbitofrontal complex as detected by fMRI in from baseline to 16-week follow-up
15 secondary outcomes
change of body weight
Time frame: 16 weeks
changes in waist circumference
Time frame: 16 weeks
changes in fasting blood sugar
Time frame: 16 weeks
changes in glucagon
Time frame: 16 weeks
changes in ghrelin
Time frame: 16 weeks
changes in leptin
Time frame: 16 weeks
changes in obestatin
Time frame: 16 weeks
changes in reelin
Time frame: 16 weeks
changes in endocannabinoids
Time frame: 16 weeks
changes in insulin
Time frame: 16 weeks
change in food addiction score
Time frame: 16 weeks
change in liking
Time frame: 16 weeks
change in wanting
Time frame: 16 weeks
change in emotional regulation abilities
Time frame: 16 weeks
BOLD in brain regions involved in the reward system
Time frame: baseline comparison
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 30 Apr 2021.
- Individual participant dataSharing planned: No
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Obesity
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.
Zoltan Pataky, MD principal investigator
University Hospital, Geneva
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 of Obesity, run by Zoltan Pataky at 1 site in Switzerland.
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 9 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 30 Apr 2021. 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 Switzerland. 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?
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 of Bold Oxygenation Level Dependent (BOLD) signal (%) in brain regions involved in the reward system (time frame: 16 weeks). 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 30 Apr 2021.