To Predict Weight Loss Response to Liraglutide (Saxenda®), From fMRI-based Determination of Food Cue Reactivity

NCT ID: NCT03795701

Last Updated: 2023-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-08
• Study Completion Date: 2022-05-01

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).

Conditions

Obesity

Keywords

Neuroimaging; Hormones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Receiving equivalent volumes of the pre-filled solutions from pen-injector as Liraglutide 3.0 group .

Liraglutide 3.0

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.

Group Type: EXPERIMENTAL

Saxenda®

Intervention Type: DRUG

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.

Interventions

Saxenda®

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.

Intervention Type: DRUG

Placebo

Receiving equivalent volumes of the pre-filled solutions from pen-injector as Liraglutide 3.0 group .

Intervention Type: OTHER

Other Intervention Names

Liraglutide 3.0

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Texas Tech University

OTHER

Sponsor Role: lead

Responsible Party

Martin Binks

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nikhil V Dhurandhar, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University

Locations

Texas Tech Neuroimaging Institute

Lubbock, Texas, United States

Nutrition & Metabolic Health Initiative

Lubbock, Texas, United States

Countries

United States

Other Identifiers

TTUIRB2018-824

Identifier Type: -

Identifier Source: org_study_id