Reward Mechanisms in Obesity (LIRAOB)

Zoltan Pataky

Status and phase: Completed; Phase 4

Conditions: Obesity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03347890

2017-01085

U1111-1194-9675 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Liraglutide 3.0 mg

Experimental group

Description:

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).

Treatment:

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

Placebo

Placebo Comparator group

Description:

35 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Placebo by pen injector.

Treatment:

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