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A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis

Plain-language guide to PMID 33185364 (2021): double-blind randomized controlled trial study of Semaglutide in 2 patients.

Key Facts

PMID
33185364
Journal
The New England journal of medicine
Year
2021
Study type
Randomized Controlled Trial
Authors
Newsome PN et al. (9 authors)
DOI
10.1056/NEJMoa2028395
Registered trial
NCT06060392, NCT02970942

What This Study Did, in Plain Language

What Was Tested

The paper reports a study of Semaglutide, published as a randomized controlled trial.

Who Took Part

The abstract describes 2 patients taking part.

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

The researchers conducted a 72-week, double-blind phase 2 trial involving patients with biopsy-confirmed NASH and liver fibrosis of stage F1, F2, or F3.

The analyses of these end points were performed only in patients with stage F2 or F3 fibrosis; other analyses were performed in all the patients.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

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

Blinding on both sides kept the patients and researchers unaware of who received Semaglutide.

A placebo (an inactive look-alike) gave the Semaglutide group a baseline to be compared against.

The primary end point was resolution of NASH with no worsening of fibrosis.

What Was Measured

Topics PubMed links to this paper include Amylases, Biopsy, Diabetes Mellitus, Type 2, Glucagon-Like Peptides, Lipase, Liver and Liver Cirrhosis.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Semaglutide in 2 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Results are reported in around 10 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2021 (The New England journal of medicine), a journal based in United States.

More context: the Semaglutide compound page.

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

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.