BNP Pharmacodynamics and Effects on Metabolism in Lean and Obese Subjects

What Was Tested

This registered phase 1 trial tested BNP (Nesiritide).

It had five arms (groups): Saline (placebo comparator), Nesiritide 1.0 (active comparator), Nesiritide 2.0 (active comparator), Nesiritide 4.0 (active comparator) and Nesiritide 8.0 (active comparator).

Saline infusion.

The registry classes the interventions as drug.

More on the Plan

This study will provide insight into the mechanisms of dysregulation of the natriuretic peptides system in obesity and will contribute to delineate the roles and the clinical importance of BNP in the treatment of obesity.

Who Took Part

The registry lists 4 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Age 18-65 years, inclusive. Men and women. Able to provide written, informed consent. Weight stable (± 3 kg) during the 3 months prior to enrollment. BMI ≤ 25 kg/m2 for lean subjects or ≥ 30 kg/m2 for obese subjects.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: pregnant or nursing women; known hypersensitivity to nesiritide or any of its excipients; poor intravenous access.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this BNP (Nesiritide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind BNP (Nesiritide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2013-11 with completion listed for 2016-02-15.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Difference in level of B-type Natriuretic Peptide (BNP) (time frame: Days -2, 7, 14).

It also tracked 4 secondary outcomes, for example Differences in the expression of NPRC and Difference in responses of lean and obese subjects.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of BNP (Nesiritide) in 4 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the BNP (Nesiritide) compound page, all human trials.