Semaglutide for the treatment of non-alcoholic steatohepatitis: Trial design and comparison of non-invasive biomarkers.

Harrison SA, Calanna S, Cusi K, Linder M, Okanoue T, Ratziu V, Sanyal A, Sejling AS, Newsome PN

Contemporary clinical trials8 Oct 2020Cited by 29 (Europe PMC)

PMID33039693DOI10.1016/j.cct.2020.106174PepBankPUB-33039693

Publisher page PubMedAsk about this study

Summary

Non-alcoholic steatohepatitis (NASH) is a chronic liver disease. There is a clear need to develop pharmacological treatment for patients with NASH as well as biomarkers that can diagnose the disease. We describe a trial of semaglutide treatment for NASH, identify key patient characteristics and compare the relationship of patient characteristics and non-invasive biomarkers/scores. NCT02970942 is a randomised, double-blind, placebo-controlled, multi-national Phase 2 trial of daily subcutaneous semaglutide (0.1 mg, 0.2 mg, 0.4 mg) in patients with biopsy-confirmed NASH, F1-F3 fibrosis, NAFLD Activity Score ≥ 4, and body mass index (BMI) > 25 kg/m². Exploratory analyses were performed to evaluate correlations between baseline parameters and biomarkers in NASH. Mean (standard deviation [SD]) age of 320 randomised patients was 55 (11) years, mean BMI was 36 (6) kg/m², and 199 (62%) had type 2 diabetes. Of the total patients, 28% had F1 fibrosis, 23% had F2 fibrosis and 49% had F3 fibrosis. The highest area under the receiver operating characteristic curve (0.69) for accuracy in classifying fibrosis stage, F2-3 versus F1, was observed for Fib-4 and Enhanced Liver Fibrosis (ELF). No substantial correlation between BMI or other clinical or biochemical parameters and fibrosis stage was observed. In this large Phase 2 trial of semaglutide treatment for NASH, the clinical profile of enrolled patients was typical for patients with NASH. Of the investigated biomarkers/scores, ELF and Fib-4 showed the most apparent correlation in classifying fibrosis stage, but had only moderate predictive value.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study2

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone2

In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Semaglutide.

01HumanNot a test of Semaglutide aloneOther designOther
In adults with biopsy-confirmed NASH at baseline of a semaglutide trial, Fib-4 and Enhanced Liver Fibrosis had the highest AUROC for classifying F2-3 versus F1 fibrosis.
In plain wordsIn adults with fatty liver disease before treatment, two blood scores were best at telling advanced from mild liver scarring, but only moderately.
Peptide
Semaglutide
Outcome
Not applicableAccuracy of Fib-4 and ELF for classifying fibrosis stage F2-3 versus F1
Study
n = 320
Outcome group
Liver fat and liver function · Liver
Measurements
AUROC
0.69 AUROC
Fib-4 and ELF, F2-3 vs F1
Source sentences
Summary
The highest area under the receiver operating characteristic curve (0.69) for accuracy in classifying fibrosis stage, F2-3 versus F1, was observed for Fib-4 and Enhanced Liver Fibrosis (ELF).
1 context sentence(design, population, supporting numbers)
Summary · context
NCT02970942 is a randomised, double-blind, placebo-controlled, multi-national Phase 2 trial of daily subcutaneous semaglutide (0.1 mg, 0.2 mg, 0.4 mg) in patients with biopsy-confirmed NASH, F1-F3 fibrosis, NAFLD Activity Score ≥ 4, and body mass index (BMI) > 25 kg/m².
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Show in the study text Report a problemFND-3303969301
02HumanNot a test of Semaglutide aloneOther designOther
In adults with biopsy-confirmed NASH at baseline of a semaglutide trial, no substantial correlation was seen between BMI or other clinical or biochemical parameters and fibrosis stage.
In plain wordsIn adults with fatty liver disease before treatment, body mass index and other measures did not clearly track with liver scarring stage.
Peptide
Semaglutide
Outcome
No significant changeCorrelation of BMI and other parameters with fibrosis stage
Study
n = 320
Outcome group
Liver fat and liver function · Liver
Source sentences
Summary
No substantial correlation between BMI or other clinical or biochemical parameters and fibrosis stage was observed.
1 context sentence(design, population, supporting numbers)
Summary · context
NCT02970942 is a randomised, double-blind, placebo-controlled, multi-national Phase 2 trial of daily subcutaneous semaglutide (0.1 mg, 0.2 mg, 0.4 mg) in patients with biopsy-confirmed NASH, F1-F3 fibrosis, NAFLD Activity Score ≥ 4, and body mass index (BMI) > 25 kg/m².
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Show in the study text Report a problemFND-3303969302

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT02970942

Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.

Novo Nordisk A/Sn = 32030 Nov 2016 to 19 Mar 2020

Hepatobiliary Disorders · Non-alcoholic Steatohepatitis

Trial page ClinicalTrials.govUpdated 16 Nov 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
11 Oct 2026, 00:50 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

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