Clinical trial NCT03795701: To Predict Weight Loss Response to Liraglutide (Saxenda®), From fMRI-based Determination of Food Cue Reactivity
Official title: To Predict Weight Loss Response to Liraglutide (Saxenda®), From fMRI-based Determination of Food Cue Reactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Neuroimaging
Hormones
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2019-01-08
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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).


Eligibility criteria: Inclusion Criteria:

* Age 18-60 years
* BMI 30-50 kg/m2

Exclusion Criteria:

* 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).
* 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.

  1. aneurism clips
  2. any implanted medical devices (pacemaker, neurostimulator)
  3. known pregnancy
  4. shrapnel in body or any injury to eye involving metal
  5. 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.

Primary outcomes:
measure: Compare the changes of pre-prandial fMRI-FCR in Liraglutide 3.0 vs. Placebo Group
timeFrame: Baseline, Week 4, and Week 16
measure: Compare the changes of post-prandial fMRI-FCR in Liraglutide 3.0 vs. Placebo Group
timeFrame: Baseline, Week 4, and Week 16
measure: Compare the changes of energy intake in Liraglutide 3.0 vs. Placebo Group
timeFrame: Baseline, Week 4, and Week 16
measure: Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group
timeFrame: Baseline, Week 4, and Week 16
measure: Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group
timeFrame: Baseline, Week 4, and Week 16
measure: Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group
timeFrame: Baseline, Week 4, and Week 16
measure: Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group
timeFrame: Baseline, Week 4, and Week 16
measure: Prediction of weight loss in Liraglutide 3.0 group by examine early change in pre-prandial fMRI-FCR
timeFrame: Baseline, Week 4, and Week 16
measure: Prediction of weight loss in Liraglutide 3.0 group by examine early change in post-prandial fMRI-FCR
timeFrame: Baseline, Week 4, and Week 16
Secondary outcomes:
measure: Correlation between changes in post-prandial fMRI-FCR and changes in energy intake
timeFrame: Baseline, Week 4, and Week 16
measure: Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety
timeFrame: Baseline, Week 4, and Week 16
measure: Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety
timeFrame: Baseline, Week 4, and Week 16
measure: Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety
timeFrame: Baseline, Week 4, and Week 16
measure: Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety
timeFrame: Baseline, Week 4, and Week 16
measure: Examine if the correlations described in outcome 10 differ in Liraglutide 3.0 vs. Placebo Group
timeFrame: Baseline, Week 4, and Week 16
measure: Examine if the correlations described in outcome 11 differ in Liraglutide 3.0 vs. Placebo Group
timeFrame: Baseline, Week 4, and Week 16
measure: Examine if the correlations described in outcome 12 differ in Liraglutide 3.0 vs. Placebo Group
timeFrame: Baseline, Week 4, and Week 16
measure: Examine if the correlations described in outcome 13 differ in Liraglutide 3.0 vs. Placebo Group
timeFrame: Baseline, Week 4, and Week 16
measure: Examine if the correlations described in outcome 14 differ in Liraglutide 3.0 vs. Placebo Group
timeFrame: Baseline, Week 4, and Week 16
measure: Prediction of weight loss after 16 weeks intervention by assessing early changes in energy intake
timeFrame: Baseline, Week 4, and Week 16
measure: Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety
timeFrame: Baseline, Week 4, and Week 16
measure: Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety
timeFrame: Baseline, Week 4, and Week 16
measure: Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety
timeFrame: Baseline, Week 4, and Week 16
measure: Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety
timeFrame: Baseline, Week 4, and Week 16
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech Neuroimaging Institute
state: Texas
city: Lubbock
country: United States
facility: Nutrition & Metabolic Health Initiative
state: Texas
Study officials:
affiliation: Texas Tech University
name: Nikhil V Dhurandhar, PhD
role: PRINCIPAL_INVESTIGATOR
References: