Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants

What Was Tested

In this phase 4 trial, researchers set out to test Setmelanotide.

This was a double-blind, randomized, placebo- and positive-controlled, parallel group, 3-arm study that assessed the potential for therapeutic and supratherapeutic concentrations of setmelanotide to affect the QTc corrected by the Fredericia method (QTcF) interval.

It had three arms (groups): one (experimental), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 77 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Participant has body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m\^2), inclusive. Female participants of childbearing potential must be confirmed non-pregnant and agree to use contraception. Participant is able to comprehend and is willing to sign an informed consent form and abide by the study restrictions.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Setmelanotide and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Setmelanotide, so expectations could not easily colour the readings.

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

It started in 2021-08-05 with completion listed for 2022-04-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10. Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16.

It also tracked 15 secondary outcomes, for example Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10, Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16, Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10, Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16, Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 and Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Setmelanotide in 77 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Setmelanotide compound page, all human trials.