ObesityNCT03795701
To Predict Weight Loss Response to Liraglutide (Saxenda®), From fMRI-based Determination of Food Cue Reactivity
A study testing Saxenda® in people with Obesity, run by Texas Tech University at 2 sites in United States.
Trial summary
The study is a single center, randomized, double blind, placebo controlled; parallel-group repeated measures design. Subjects will be randomly assigned to either Saxenda® or placebo group after baseline assessments. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Saxenda®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jan 2019to 1 May 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60 years
- BMI 30-50 kg/m2
Who cannot join
- Participants unable or unwilling to provide informed consent.
- Participants with motor, visual or hearing impairment.
- Females with irregular menstrual cycles (onset of menstruation greater than 1 week from expected data during the last 3 months).
- Females who are currently breastfeeding or intend to start breastfeeding.
- Participants with diagnosed diabetes mellitus (type 1 or type 2) or uncontrolled hypertension, history of ischemic heart disease, stroke, neurological disease.
- Participants with current severe psychiatric illnesses (e.g. psychosis, schizophrenia, bipolar disorders, depression).
Show all 33Show fewer
- Participants experiencing current suicidal ideation, and recent or past suicide attempts.
- Participants with history of psychiatric hospitalization.
- Participants who are currently on (or have been on within the past 4 weeks) any medication in the broader drug classes of anti-depressant, anti-epileptic, or anti-anxiety medicines will be excluded (as these affect fMRI-FCR in the brain).
- Participants with contraindications for MRI scanning.
- aneurism clips
- any implanted medical devices (pacemaker, neurostimulator)
- known pregnancy
- shrapnel in body or any injury to eye involving metal
- any ferrous metal in body
- Participants with a history of diagnosed eating disorders such as bulimia nervosa, anorexia nervosa and severe binge eating disorder.
- Participants with a history of diagnosed substance abuse or alcohol abuse.
- Patients experiencing persistent loss of appetite, nausea or vomiting within the last 4 weeks without known cause (e.g. flu, food poisoning).
- Participants who have been involved in a weight loss intervention program (including anti-obesity medication) within the past 3 months (and or loss >10% of body weight) or who have ever had bariatric surgery or have weight loss devices implanted.
- Current smokers (smoked within the last 30 days).
- The receipt of any investigational drug within (3 months) prior to this trial.
- Previous participation in this trial (i.e. randomized).
- Unable or unwilling to consume required study meals for any reason (e.g. dietary restrictions, allergies, or aversions to any of the food items used in the study).
- Contraindications to study medications,
- Subject with a personal or family history of medullary thyroid carcinoma (MTC).
- Subject with multiple endocrine neoplasia syndrome 2 (MEN 2).
- Allergic to Liraglutide or any of the ingredients in Saxenda® (i.e. Active ingredient: liraglutide; Inactive ingredients: disodium phosphate dehydrate, propylene glycol, phenol and water for injection)
- Women who are pregnant, or have the intention of becoming pregnant.
- Taking other GLP-1 receptor agonists (currently or in the past 3 months).
- Current severe problems with stomach, such as slowed emptying of the stomach (gastroparesis) or problems with digesting food.
- Current or past known serious chronic illness of liver, kidney and pancreas.
- Current or recent (30 days) depression or suicidal thoughts.
- Current fasting plasma glucose 126mg/dL or higher or HbA1c 6.5% or higher, or alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, blood urea nitrogen (BUN) 10% above normal range for the assay.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Tech Neuroimaging Institute
Lubbock, Texas, 79409
Nutrition & Metabolic Health Initiative
Lubbock, Texas, 79410
About this study
The study is a single center, randomized, double blind, placebo controlled; parallel-group repeated measures design. Subjects will be randomly assigned to either Saxenda® or placebo group after baseline assessments. The study will consist of a 4-week partial dose period (Liraglutide 0.6mg, 1.2mg, 1.8mg, 2.4 mg) and a 12-week full-dose (Liraglutide 3.0 mg) period. The placebo group will administer equivalent volumes of the pre-filled solutions from pen-injector at the same time, using the same method during this period. The study proposes to identify factors contributing to early weight loss response in a Saxenda® treatment program. Specifically, the proposed experiments will help determine if Saxenda® changes brain functional Magnetic Resonance Imaging Food Cue Reactivity (fMRI-FCR) and whether the magnitude of that change is associated with changes in behavioral and physiological variables (hunger, satiety, cravings and weight loss).
- Conditions
- Obesity
- Being tested
- Saxenda®, Placebo
- Keywords
- Neuroimaging, Hormones
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saxenda®Drug
Also called Liraglutide 3.0
Receiving escalating dose of Saxenda® for the first 4 weeks (0.6mg, 1.2mg, 1.8mg, 2.4 mg) and receiving full-dose (3.0 mg) for 12 weeks.
PlaceboOther
Receiving equivalent volumes of the pre-filled solutions from pen-injector as Liraglutide 3.0 group .
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects in placebo group will receive placebo plus behavioral weight loss counselling to portion control to achieve 500 kcal daily deficit based on MedGem required maintenance calories (not to be reduced below 1000 kcal per day for any subject). Subjects will also be asked to maintain physical activity. Receives: Other: Placebo |
| Liraglutide 3.0 | Experimental | Subjects in Liraglutide 3.0 group will receive Saxenda® plus behavioral weight loss counselling to portion control to achieve 500 kcal daily deficit based on MedGem required maintenance calories (not to be reduced below 1000 kcal per day for any subject). Subjects will be asked to maintain physical activity. The dose of Saxenda® will be increased weekly in the first 4 weeks (.6; 1.2; 1.8; 2.4 mg) and maintained on 3 mg for 12 weeks. Receives: Drug: Saxenda® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the changes of pre-prandial fMRI-FCR in Liraglutide 3.0 vs. Placebo Group
Pre-prandial fMRI-FCR will be measured via fMRI
Measured: Baseline, Week 4, and Week 16
Compare the changes of post-prandial fMRI-FCR in Liraglutide 3.0 vs. Placebo Group
Post-prandial fMRI-FCR will be measured via fMRI
Measured: Baseline, Week 4, and Week 16
Compare the changes of energy intake in Liraglutide 3.0 vs. Placebo Group
Energy intake will be assessed via ad libitum feeding
Measured: Baseline, Week 4, and Week 16
Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group
Hunger/satiety will be assessed via Visual Analog Scale (VAS). Subjects will rate on the 100 mm line with a vertical line. There is no specific number on the scale. On each 100-mm line, an sensation is paired with the opposing sensation, (for example, 'not at all hungry' and 'extremely hungry' or 'Not at all satiated' and 'extremely satiated').
Measured: Baseline, Week 4, and Week 16
Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group
Hunger/satiety will be assessed via glucagon-like peptide-1 (GLP-1)
Measured: Baseline, Week 4, and Week 16
Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group
Hunger/satiety will be assessed via Peptide YY (PYY)
Measured: Baseline, Week 4, and Week 16
Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group
Hunger/satiety will be assessed via ghrelin
Measured: Baseline, Week 4, and Week 16
Prediction of weight loss in Liraglutide 3.0 group by examine early change in pre-prandial fMRI-FCR
Pre-prandial fMRI-FCR will be measured via fMRI
Measured: Baseline, Week 4, and Week 16
Prediction of weight loss in Liraglutide 3.0 group by examine early change in post-prandial fMRI-FCR
Post-prandial fMRI-FCR will be measured via fMRI
Measured: Baseline, Week 4, and Week 16
Secondary outcomes (15)
Correlation between changes in post-prandial fMRI-FCR and changes in energy intake
Post-prandial fMRI-FCR measured via fMRI. Energy intake will be assessed via ad libitum feeding.
Measured: Baseline, Week 4, and Week 16
Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety
Post-prandial fMRI-FCR measured via fMRI. Hunger/satiety will be measured via Visual Analog Scale (VAS). Subjects will rate on the 100 mm line with a vertical line. There is no specific number on the scale. On each 100-mm line, an sensation was paired with the opposing sensation, (for example, 'not at all hungry' and 'extremely hungry').
Measured: Baseline, Week 4, and Week 16
Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety
Post-prandial fMRI-FCR measured via fMRI. Hunger/satiety will be measured via glucagon-like peptide-1 (GLP-1).
Measured: Baseline, Week 4, and Week 16
Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety
Post-prandial fMRI-FCR measured via fMRI. Hunger/satiety will be measured via peptide YY (PYY).
Measured: Baseline, Week 4, and Week 16
Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety
Post-prandial fMRI-FCR measured via fMRI. Hunger/satiety will be measured via ghrelin.
Measured: Baseline, Week 4, and Week 16
Examine if the correlations described in outcome 10 differ in Liraglutide 3.0 vs. Placebo Group
Energy intake will be assessed via ad libitum feeding.
Measured: Baseline, Week 4, and Week 16
Examine if the correlations described in outcome 11 differ in Liraglutide 3.0 vs. Placebo Group
Hunger/satiety will be measured via Visual Analog Scale (VAS). Subjects will rate on the 100 mm line with a vertical line. There is no specific number on the scale. On each 100-mm line, an sensation was paired with the opposing sensation, (for example, 'not at all hungry' and 'extremely hungry').
Measured: Baseline, Week 4, and Week 16
Examine if the correlations described in outcome 12 differ in Liraglutide 3.0 vs. Placebo Group
Hunger/satiety will be measured via glucagon-like peptide-1 (GLP-1)
Measured: Baseline, Week 4, and Week 16
Examine if the correlations described in outcome 13 differ in Liraglutide 3.0 vs. Placebo Group
Hunger/satiety will be measured via peptide YY (PYY)
Measured: Baseline, Week 4, and Week 16
Examine if the correlations described in outcome 14 differ in Liraglutide 3.0 vs. Placebo Group
Hunger/satiety will be measured via ghrelin
Measured: Baseline, Week 4, and Week 16
Prediction of weight loss after 16 weeks intervention by assessing early changes in energy intake
Energy intake will be assessed via ad libitum feeding
Measured: Baseline, Week 4, and Week 16
Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety
Hunger/satiety will be measured via Visual Analog Scale (VAS). Subjects will rate on the 100 mm line with a vertical line. There is no specific number on the scale. On each 100-mm line, an sensation was paired with the opposing sensation, (for example, 'not at all hungry' and 'extremely hungry' or 'Not at all satiated' and 'extremely satiated').
Measured: Baseline, Week 4, and Week 16
Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety
Hunger/satiety will be measured via glucagon-like peptide-1 (GLP-1)
Measured: Baseline, Week 4, and Week 16
Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety
Hunger/satiety will be measured via peptide YY (PYY)
Measured: Baseline, Week 4, and Week 16
Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety
Hunger/satiety will be measured via ghrelin
Measured: Baseline, Week 4, and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start8 Jan 2019
- Primary completion1 May 2022
- Study completion1 May 2022
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Martin Binks, Texas Tech University
- Investigators
- Nikhil V Dhurandhar, PhD, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795701
- Sponsor's protocol ID
- TTUIRB2018-824
- Status last verified
- Nov 2023
- First submitted
- 17 Dec 2018
- Last updated
- 4 Dec 2023
- 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 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Predict Weight Loss Response to Liraglutide (Saxenda®), From fMRI-based Determination of Food Cue Reactivity
- ClinicalTrials.gov ID
- NCT03795701
- Acronym / sponsor ID
- TTUIRB2018-824
- Conditions
- Obesity
- Keywords
- Neuroimaging, Hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 8 Jan 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 study is a single center, randomized, double blind, placebo controlled; parallel-group repeated measures design. Subjects will be randomly assigned to either Saxenda® or placebo group after baseline assessments. The study will consist of a 4-week partial dose period (Liraglutide 0.6mg, 1.2mg, 1.8mg, 2.4 mg) and a 12-week full-dose (Liraglutide 3.0 mg) period. The placebo group will administer equivalent volumes of the pre-filled solutions from pen-injector at the same time, using the same method during this period. The study proposes to identify factors contributing to early weight loss response in a Saxenda® treatment program. Specifically, the proposed experiments will help determine if Saxenda® changes brain functional Magnetic Resonance Imaging Food Cue Reactivity (fMRI-FCR) and whether the magnitude of that change is associated with changes in behavioral and physiological variables (hunger, satiety, cravings and weight loss).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboSubjects in placebo group will receive placebo plus behavioral weight loss counselling to portion control to achieve 500 kcal daily deficit based on MedGem required maintenance calories (not to be reduced below 1000 kcal per day for any subject). Subjects will also be asked to maintain physical activity. |
| Liraglutide 3.0 | Experimental | Drug: Saxenda®Subjects in Liraglutide 3.0 group will receive Saxenda® plus behavioral weight loss counselling to portion control to achieve 500 kcal daily deficit based on MedGem required maintenance calories (not to be reduced below 1000 kcal per day for any subject). Subjects will be asked to maintain physical activity. The dose of Saxenda® will be increased weekly in the first 4 weeks (.6; 1.2; 1.8; 2.4 mg) and maintained on 3 mg for 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-60 years
- BMI 30-50 kg/m2
Key exclusion criteria (33 listed)
- Participants unable or unwilling to provide informed consent.
- Participants with motor, visual or hearing impairment.
- Females with irregular menstrual cycles (onset of menstruation greater than 1 week from expected data during the last 3 months).
- Females who are currently breastfeeding or intend to start breastfeeding.
- Participants with diagnosed diabetes mellitus (type 1 or type 2) or uncontrolled hypertension, history of ischemic heart disease, stroke, neurological disease.
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 |
|---|---|---|
| Saxenda®Also: Liraglutide 3.0Receiving escalating dose of Saxenda® for the first 4 weeks (0.6mg, 1.2mg, 1.8mg, 2.4 mg) and receiving full-dose (3.0 mg) for 12 weeks. | Drug | Liraglutide 3.0 |
| PlaceboReceiving equivalent volumes of the pre-filled solutions from pen-injector as Liraglutide 3.0 group . | Other | Placebo |
Primary outcome
Compare the changes of pre-prandial fMRI-FCR in Liraglutide 3.0 vs. Placebo Group
Time frame: Baseline, Week 4, and Week 16
Pre-prandial fMRI-FCR will be measured via fMRI
Compare the changes of post-prandial fMRI-FCR in Liraglutide 3.0 vs. Placebo Group
Time frame: Baseline, Week 4, and Week 16
Post-prandial fMRI-FCR will be measured via fMRI
Compare the changes of energy intake in Liraglutide 3.0 vs. Placebo Group
Time frame: Baseline, Week 4, and Week 16
Energy intake will be assessed via ad libitum feeding
Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group
Time frame: Baseline, Week 4, and Week 16
Hunger/satiety will be assessed via Visual Analog Scale (VAS). Subjects will rate on the 100 mm line with a vertical line. There is no specific number on the scale. On each 100-mm line, an sensation is paired with the opposing sensation, (for example, 'not at all hungry' and 'extremely hungry' or 'Not at all satiated' and 'extremely satiated').
Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group
Time frame: Baseline, Week 4, and Week 16
Hunger/satiety will be assessed via glucagon-like peptide-1 (GLP-1)
Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group
Time frame: Baseline, Week 4, and Week 16
Hunger/satiety will be assessed via Peptide YY (PYY)
Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group
Time frame: Baseline, Week 4, and Week 16
Hunger/satiety will be assessed via ghrelin
Prediction of weight loss in Liraglutide 3.0 group by examine early change in pre-prandial fMRI-FCR
Time frame: Baseline, Week 4, and Week 16
Pre-prandial fMRI-FCR will be measured via fMRI
Prediction of weight loss in Liraglutide 3.0 group by examine early change in post-prandial fMRI-FCR
Time frame: Baseline, Week 4, and Week 16
Post-prandial fMRI-FCR will be measured via fMRI
15 secondary outcomes
Correlation between changes in post-prandial fMRI-FCR and changes in energy intake
Time frame: Baseline, Week 4, and Week 16
Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety
Time frame: Baseline, Week 4, and Week 16
Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety
Time frame: Baseline, Week 4, and Week 16
Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety
Time frame: Baseline, Week 4, and Week 16
Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety
Time frame: Baseline, Week 4, and Week 16
Examine if the correlations described in outcome 10 differ in Liraglutide 3.0 vs. Placebo Group
Time frame: Baseline, Week 4, and Week 16
Examine if the correlations described in outcome 11 differ in Liraglutide 3.0 vs. Placebo Group
Time frame: Baseline, Week 4, and Week 16
Examine if the correlations described in outcome 12 differ in Liraglutide 3.0 vs. Placebo Group
Time frame: Baseline, Week 4, and Week 16
Examine if the correlations described in outcome 13 differ in Liraglutide 3.0 vs. Placebo Group
Time frame: Baseline, Week 4, and Week 16
Examine if the correlations described in outcome 14 differ in Liraglutide 3.0 vs. Placebo Group
Time frame: Baseline, Week 4, and Week 16
Prediction of weight loss after 16 weeks intervention by assessing early changes in energy intake
Time frame: Baseline, Week 4, and Week 16
Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety
Time frame: Baseline, Week 4, and Week 16
Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety
Time frame: Baseline, Week 4, and Week 16
Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety
Time frame: Baseline, Week 4, and Week 16
Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety
Time frame: Baseline, Week 4, and Week 16
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 4 Dec 2023.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Nikhil V Dhurandhar, PhD principal investigator
Texas Tech University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saxenda® in people with Obesity, run by Texas Tech University at 2 sites in United States.
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 2 inclusion and 33 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 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
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?
Compare the changes of pre-prandial fMRI-FCR in Liraglutide 3.0 vs. Placebo Group (time frame: Baseline, Week 4, and Week 16). The study lists 9 primary outcomes in all. 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 4 Dec 2023.