Study of the Cardiometabolic Effects of Obesity Pharmacotherapy

Sponsor
National and Kapodistrian University of Athens
Study ID
NCT04575194
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Liraglutide 6 MG/ML [Saxenda] — DRUG
    3 mg of sc liraglutide daily plus lifestyle intervention
  • Naltrexone-Bupropion Combination — DRUG
    32/360 mg of oral lnaltrexone-bupropion daily plus lifestyle intervention

Study Details

The aim of the present study is to compare the efficacy of liraglutide vs. naltrexone/bupropion on metabolic and cardiovascular risk markers, weight loss, as well as the postprandial secretion of gastrointestinal hormones involved in hunger and satiety, after a test meal. The study will include 40 patients, who will further be divided into two treatment groups (20 patients on liraglutide vs. 20 patients on naltrexone/bupropion). The patients will be examined at baseline, 3 and 6 months after the treatment initiation.

Key Dates

Start date
Sep 8, 2020
Status verified
Oct 2020
Primary completion
Sep 30, 2022
Completion
May 30, 2023

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Liraglutide 3 mg
    Patients will be prescribed sc liraglutide 3 mg/day along with a dietary and physical activity intervention.
  • Active Comparator: Naltrexone/bupropion 32/360 mg
    Patients will be prescribed oral naltrexone/bupropion 32/360 mg/day along with a dietary and physical activity intervention.

Primary Outcome Measure

Changes in blood pressure [ Time Frame: 3 and 6 months ]

Central Contacts

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