Thorough QT/QTc Study Evaluating the Effect of Macimorelin on Cardiac Safety Parameters in Healthy Participants

Plain-language guide to PMID 32961034 (2021): double-blind randomized controlled trial study of Macimorelin (non-peptide).

Key Facts

PMID: 32961034
Journal: Clinical pharmacology in drug development
Year: 2021
Study type: Randomized Controlled Trial
Authors: Lissy M et al. (6 authors)
DOI: 10.1002/cpdd.872

What This Study Did, in Plain Language

What Was Tested

Researchers studied Macimorelin (non-peptide) in this randomized controlled trial publication.

The primary objective of this study was to evaluate the effect of macimorelin on the baseline and placebo-corrected mean QT interval using Fridericia's formula (ΔΔQTcF).

Why It Was Studied

Macimorelin is an orally active growth hormone secretagogue indicated for the diagnosis of adult growth hormone deficiency.

Data were collected over a 3-month span from male (n=36) and female participants (n=24) aged 18 to 55 years with body mass index between 18.5 and 30.0 kg/m2 .

Who Took Part

The age groups tagged for this paper are teenagers, young adults, adults and middle-aged adults, both men and women.

How the Study Was Run

The design is described as randomized, double-blind, placebo-controlled and crossover.

Random assignment meant chance, not the researchers, decided who got Macimorelin (non-peptide) and who got the comparison, which limits bias.

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

Some participants received a placebo instead of Macimorelin (non-peptide), giving a reference point.

In the crossover set-up each of the participants took both Macimorelin (non-peptide) and the comparison in turn, acting as their own control.

The timeline in the abstract includes 3 months.

What Was Measured

Topics PubMed links to this paper include Electrocardiography, Heart Rate, Indoles, Long QT Syndrome, Moxifloxacin and Tryptophan.

Author keywords: QT prolongation, cardiac repolarization, growth hormone and macimorelin.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Macimorelin (non-peptide) over 3 months.

The publication is from 2021 (Clinical pharmacology in drug development), a journal based in United States.

More context: the Macimorelin (non-peptide) compound page, all human trials.

Our Notes on the Compound

Macimorelin (non-peptide): An oral ghrelin-receptor agonist approved by the FDA (Macrilen) as a one-time diagnostic test for adult growth hormone deficiency.

Macimorelin (non-peptide) in the library

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.