NCT03347890

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_4 obesity

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2020

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

November 12, 2017

Last Update Submit

April 29, 2021

Conditions

Obesity

Keywords

GLP-1fMRI

Outcome Measures

Primary Outcomes (1)

  • 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

    16 weeks

Secondary Outcomes (15)

  • change of body weight

    16 weeks

  • changes in waist circumference

    16 weeks

  • changes in fasting blood sugar

    16 weeks

  • changes in glucagon

    16 weeks

  • changes in ghrelin

    16 weeks

  • +10 more secondary outcomes

Study Arms (2)

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).

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.

Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or Placebo

Interventions

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.

Liraglutide 3.0 mgPlacebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma
  • pregnancy
  • contraindications for fMRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Geneva

Geneva, 1206, Switzerland

Location

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Zoltan Pataky, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, single-centre, double-blind, placebo controlled, parallel group, clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 12, 2017

First Posted

November 20, 2017

Study Start

March 5, 2018

Primary Completion

March 18, 2020

Study Completion

March 30, 2020

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)