Setmelanotide for the treatment of acquired hypothalamic obesity: a phase 2, open-label, multicentre trial

What Was Tested

Researchers studied Alpha-MSH and Setmelanotide in this clinical trial, phase ii publication.

Hypothalamic obesity resulting from hypothalamic damage might affect melanocortin signalling.

The researchers investigated the melanocortin-4 receptor agonist setmelanotide for treatment of hypothalamic obesity.

Who Took Part

PubMed indexes the participants as children, teenagers, young adults and adults, both men and women.

Eligible patients were aged between 6 and 40 years with obesity and history of hypothalamic injury or diagnosis of a non-malignant tumour affecting the hypothalamus that was treated with surgery, chemotherapy, or radiation.

How the Study Was Run

The design is described as open-label and multicenter.

Nothing was hidden in this open-label Alpha-MSH study: the participants and staff both knew the treatment.

More than one site took part, so the participants came from several places.

This phase 2, open-label, multicentre trial was done in five centres in the USA.

This trial is registered with ClinicalTrials.gov (NCT04725240) and is complete.

What Was Measured

The subject headings attached to it are Obesity, Hypothalamic Diseases, alpha-MSH, Receptor, Melanocortin, Type 4 and Body Mass Index.

What This Means in Plain Language

The paper is an open-label and multicenter study of Alpha-MSH and Setmelanotide.

The abstract goes on to report its results in about 11 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2024 (The lancet. Diabetes & endocrinology), a journal based in England.

More context: the Alpha-MSH compound page and the Setmelanotide compound page, all human trials.