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

NCT03795701 | Completed

• 1 other identifier: TTUIRB2018-824
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (9)

• Compare the changes of pre-prandial fMRI-FCR in Liraglutide 3.0 vs. Placebo Group

  Pre-prandial fMRI-FCR will be measured via fMRI

  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

  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

  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').

  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)

  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)

  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

  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

  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

  Baseline, Week 4, and Week 16

Secondary Outcomes (15)

• Correlation between changes in post-prandial fMRI-FCR and changes in energy intake

  Baseline, Week 4, and Week 16

• Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety

  Baseline, Week 4, and Week 16

• Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety

  Baseline, Week 4, and Week 16

• Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety

  Baseline, Week 4, and Week 16

• Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety

  Baseline, Week 4, and Week 16

Study Arms (2)

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.

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.

Drug: Saxenda®

Interventions

Saxenda® 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.

Also known as: Liraglutide 3.0

Liraglutide 3.0

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years
• BMI 30-50 kg/m2

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Texas Tech University: lead
• Novo Nordisk A/S: collaborator

Study Sites (2)

Texas Tech Neuroimaging Institute

Lubbock, Texas, 79409, United States

Location

Nutrition & Metabolic Health Initiative

Lubbock, Texas, 79410, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Nikhil V Dhurandhar, PhD

  Texas Tech University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: January 8, 2019
• Study Start: January 8, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

US (2)