Study of the Cardiometabolic Effects of Obesity Pharmacotherapy

What Was Tested

The trial (phase 4) is built around Liraglutide for low blood pressure and orthostatic hypotension.

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.

It had two arms (groups): one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

This is a prospective study of patients aged ≥18 years, who are overweight (BMI ≥ 27 kg / m2 in the presence of dyslipidemia or hypertension or obstructive sleep apnea or fatty infiltration or prediabetes) or obese patients (BMI ≥ 30 kg / m2).

Patients' data will be collected before starting medication (time 0) and at 3 and 6 months under treatment in the clinical practice of the selected drug, as described in the drug's package leaflet, along with a simultaneous dietary intervention and exercise.

Patient groups will be comparable in age, gender and BMI.

Who Took Part

40 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: presence of any clinical contraindications for the administration of liraglutide or bupropion / naltrexone; bariatric surgery; diabetes type 2.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

Groups ran in parallel: each of the low blood pressure and orthostatic hypotension participants stayed in one arm throughout.

Nothing was hidden in this open-label Liraglutide study: the low blood pressure and orthostatic hypotension participants and staff both knew the treatment.

It started in 2020-09-08 with completion listed for 2022-09-30.

It ran at 1 site in Greece.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Changes in blood pressure (time frame: 3 and 6 months).

It also tracked 9 secondary outcomes, for example Weight loss, Changes in glycemic, Changes in lipemic profile, Percentage of visceral fat, Fat mass and Fat free mass.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Liraglutide in 40 people with low blood pressure and orthostatic hypotension.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, Low blood pressure and orthostatic hypotension research.