Study · Randomized controlled trial · 2021

10 results

A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis.

Newsome PN, Buchholtz K, Cusi K, Linder M, Okanoue T, Ratziu V, Sanyal AJ, Sejling AS, Harrison SA

The New England journal of medicine13 Nov 2020Cited by 1,616 (Europe PMC)

PMID33185364DOI10.1056/nejmoa2028395PepBankPUB-33185364

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with NASH and stage F2 or F3 fibrosis, NASH resolved without worsening of fibrosis in 40% with semaglutide 0.1 mg and 17% with placebo.
In plain wordsIn patients with NASH, the liver disease resolved in 40% on semaglutide 0.1 mg and 17% on placebo.
Peptide
Semaglutide
Outcome
Direction not reportedNASH resolution with no worsening of fibrosis, 0.1 mg
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Liver fat and liver function · Liver
Studied dose
0.1 mg once daily · subcutaneous · 72 weeksAs given in this study (human).
Measurements
NASH resolution
40%
semaglutide 0.1 mg
NASH resolution
17%
placebo
Source sentences
Summary
The percentage of patients in whom NASH resolution was achieved with no worsening of fibrosis was 40% in the 0.1-mg group, 36% in the 0.2-mg group, 59% in the 0.4-mg group, and 17% in the placebo group (P<0.001 for semaglutide 0.4 mg vs. placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 72-week, double-blind phase 2 trial involving patients with biopsy-confirmed NASH and liver fibrosis of stage F1, F2, or F3.
Summary · context
Patients were randomly assigned, in a 3:3:3:1:1:1 ratio, to receive once-daily subcutaneous semaglutide at a dose of 0.1, 0.2, or 0.4 mg or corresponding placebo.
Report a problemFND-3318536401
02HumanRandomized controlled trialEfficacy outcome
In patients with NASH and stage F2 or F3 fibrosis, NASH resolved without worsening of fibrosis in 36% with semaglutide 0.2 mg and 17% with placebo.
In plain wordsIn patients with NASH, the liver disease resolved in 36% on semaglutide 0.2 mg and 17% on placebo.
Peptide
Semaglutide
Outcome
Direction not reportedNASH resolution with no worsening of fibrosis, 0.2 mg
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Liver fat and liver function · Liver
Studied dose
0.2 mg once daily · subcutaneous · 72 weeksAs given in this study (human).
Measurements
NASH resolution
36%
semaglutide 0.2 mg
NASH resolution
17%
placebo
Source sentences
Summary
The percentage of patients in whom NASH resolution was achieved with no worsening of fibrosis was 40% in the 0.1-mg group, 36% in the 0.2-mg group, 59% in the 0.4-mg group, and 17% in the placebo group (P<0.001 for semaglutide 0.4 mg vs. placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 72-week, double-blind phase 2 trial involving patients with biopsy-confirmed NASH and liver fibrosis of stage F1, F2, or F3.
Summary · context
Patients were randomly assigned, in a 3:3:3:1:1:1 ratio, to receive once-daily subcutaneous semaglutide at a dose of 0.1, 0.2, or 0.4 mg or corresponding placebo.
Report a problemFND-3318536402
03HumanRandomized controlled trialEfficacy outcome
In patients with NASH and stage F2 or F3 fibrosis, NASH resolved without worsening of fibrosis in 59% with semaglutide 0.4 mg versus 17% with placebo.
In plain wordsIn patients with NASH, the liver disease resolved in 59% on semaglutide 0.4 mg compared with 17% on placebo.
Peptide
Semaglutide
Outcome
IncreaseNASH resolution with no worsening of fibrosis, 0.4 mg
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Liver fat and liver function · Liver
Studied dose
0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).
Measurements
NASH resolution
59%
semaglutide 0.4 mg
NASH resolution
17%
placebo
Source sentences
Summary
The percentage of patients in whom NASH resolution was achieved with no worsening of fibrosis was 40% in the 0.1-mg group, 36% in the 0.2-mg group, 59% in the 0.4-mg group, and 17% in the placebo group (P<0.001 for semaglutide 0.4 mg vs. placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 72-week, double-blind phase 2 trial involving patients with biopsy-confirmed NASH and liver fibrosis of stage F1, F2, or F3.
Summary · context
Patients were randomly assigned, in a 3:3:3:1:1:1 ratio, to receive once-daily subcutaneous semaglutide at a dose of 0.1, 0.2, or 0.4 mg or corresponding placebo.
Report a problemFND-3318536403
04HumanRandomized controlled trialEfficacy outcome
In patients with NASH and stage F2 or F3 fibrosis, fibrosis stage improved in 43% with semaglutide 0.4 mg and 33% with placebo, which was not a significant difference.
In plain wordsIn patients with NASH and stage F2 or F3 liver scarring, semaglutide 0.4 mg did not significantly improve scarring compared with placebo (43% vs 33%).
Peptide
Semaglutide
Outcome
No significant changeImprovement of at least one fibrosis stage with no worsening of NASH
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Liver fat and liver function · Liver
Studied dose
0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).
Measurements
Fibrosis improvement
43%
semaglutide 0.4 mg
Fibrosis improvement
33%
placebo
Source sentences
Summary
An improvement in fibrosis stage occurred in 43% of the patients in the 0.4-mg group and in 33% of the patients in the placebo group (P = 0.48).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 72-week, double-blind phase 2 trial involving patients with biopsy-confirmed NASH and liver fibrosis of stage F1, F2, or F3.
Summary · context
Patients were randomly assigned, in a 3:3:3:1:1:1 ratio, to receive once-daily subcutaneous semaglutide at a dose of 0.1, 0.2, or 0.4 mg or corresponding placebo.
Report a problemFND-3318536404
05HumanRandomized controlled trialEfficacy outcome
In patients with NASH, mean percent weight loss was 13% with semaglutide 0.4 mg and 1% with placebo.
In plain wordsIn patients with NASH, semaglutide 0.4 mg led to 13% average weight loss compared with 1% on placebo.
Peptide
Semaglutide
Outcome
DecreasePercent weight loss
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).
Measurements
Mean weight loss
13%
semaglutide 0.4 mg
Mean weight loss
1%
placebo
Source sentences
Summary
The mean percent weight loss was 13% in the 0.4-mg group and 1% in the placebo group.
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 72-week, double-blind phase 2 trial involving patients with biopsy-confirmed NASH and liver fibrosis of stage F1, F2, or F3.
Summary · context
Patients were randomly assigned, in a 3:3:3:1:1:1 ratio, to receive once-daily subcutaneous semaglutide at a dose of 0.1, 0.2, or 0.4 mg or corresponding placebo.
Report a problemFND-3318536405
06HumanRandomized controlled trialSafety outcome
In patients with NASH, nausea occurred more often with semaglutide 0.4 mg than with placebo (42% vs 11%).
In plain wordsIn patients with NASH, nausea happened more often with semaglutide 0.4 mg (42%) than with placebo (11%).
Peptide
Semaglutide
Outcome
IncreaseNausea
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).
Measurements
Nausea
42%
semaglutide 0.4 mg
Nausea
11%
placebo
Source sentences
Summary
nausea, 42% vs. 11%
3 context sentences(design, population, supporting numbers)
Summary · context
The incidence of nausea, constipation, and vomiting was higher in the 0.4-mg group than in the placebo group
Summary · context
We conducted a 72-week, double-blind phase 2 trial involving patients with biopsy-confirmed NASH and liver fibrosis of stage F1, F2, or F3.
Summary · context
Patients were randomly assigned, in a 3:3:3:1:1:1 ratio, to receive once-daily subcutaneous semaglutide at a dose of 0.1, 0.2, or 0.4 mg or corresponding placebo.
Report a problemFND-3318536406
07HumanRandomized controlled trialSafety outcome
In patients with NASH, constipation occurred more often with semaglutide 0.4 mg than with placebo (22% vs 12%).
In plain wordsIn patients with NASH, constipation happened more often with semaglutide 0.4 mg (22%) than with placebo (12%).
Peptide
Semaglutide
Outcome
IncreaseConstipation
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).
Measurements
Constipation
22%
semaglutide 0.4 mg
Constipation
12%
placebo
Source sentences
Summary
constipation, 22% vs. 12%
3 context sentences(design, population, supporting numbers)
Summary · context
The incidence of nausea, constipation, and vomiting was higher in the 0.4-mg group than in the placebo group
Summary · context
We conducted a 72-week, double-blind phase 2 trial involving patients with biopsy-confirmed NASH and liver fibrosis of stage F1, F2, or F3.
Summary · context
Patients were randomly assigned, in a 3:3:3:1:1:1 ratio, to receive once-daily subcutaneous semaglutide at a dose of 0.1, 0.2, or 0.4 mg or corresponding placebo.
Report a problemFND-3318536407
08HumanRandomized controlled trialSafety outcome
In patients with NASH, vomiting occurred more often with semaglutide 0.4 mg than with placebo (15% vs 2%).
In plain wordsIn patients with NASH, vomiting happened more often with semaglutide 0.4 mg (15%) than with placebo (2%).
Peptide
Semaglutide
Outcome
IncreaseVomiting
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).
Measurements
Vomiting
15%
semaglutide 0.4 mg
Vomiting
2%
placebo
Source sentences
Summary
vomiting, 15% vs. 2%
3 context sentences(design, population, supporting numbers)
Summary · context
The incidence of nausea, constipation, and vomiting was higher in the 0.4-mg group than in the placebo group
Summary · context
We conducted a 72-week, double-blind phase 2 trial involving patients with biopsy-confirmed NASH and liver fibrosis of stage F1, F2, or F3.
Summary · context
Patients were randomly assigned, in a 3:3:3:1:1:1 ratio, to receive once-daily subcutaneous semaglutide at a dose of 0.1, 0.2, or 0.4 mg or corresponding placebo.
Report a problemFND-3318536408
09HumanRandomized controlled trialSafety outcome
Malignant neoplasms were reported in 3 patients who received semaglutide (1%) and in no patients who received placebo.
In plain wordsCancers were reported in 3 patients (1%) who received semaglutide and in none who received placebo.
Peptide
Semaglutide
Outcome
Direction not reportedMalignant neoplasms
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
0.1, 0.2 or 0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).
Measurements
Malignant neoplasms
3 patients
semaglutide
Malignant neoplasms
1%
semaglutide
Source sentences
Summary
Malignant neoplasms were reported in 3 patients who received semaglutide (1%) and in no patients who received placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 72-week, double-blind phase 2 trial involving patients with biopsy-confirmed NASH and liver fibrosis of stage F1, F2, or F3.
Summary · context
Patients were randomly assigned, in a 3:3:3:1:1:1 ratio, to receive once-daily subcutaneous semaglutide at a dose of 0.1, 0.2, or 0.4 mg or corresponding placebo.
Report a problemFND-3318536409
10HumanRandomized controlled trialSafety outcome
Neoplasms of any type were reported in 15% of patients in the semaglutide groups and 8% in the placebo group, with no pattern in specific organs.
In plain wordsGrowths of any type were reported in 15% of patients on semaglutide and 8% on placebo, with no pattern in specific organs.
Peptide
Semaglutide
Outcome
Direction not reportedNeoplasms overall (benign, malignant or unspecified)
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
0.1, 0.2 or 0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).
Measurements
Neoplasms overall
15%
semaglutide groups
Neoplasms overall
8%
placebo
Source sentences
Summary
Overall, neoplasms (benign, malignant, or unspecified) were reported in 15% of the patients in the semaglutide groups and in 8% in the placebo group; no pattern of occurrence in specific organs was observed.
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 72-week, double-blind phase 2 trial involving patients with biopsy-confirmed NASH and liver fibrosis of stage F1, F2, or F3.
Summary · context
Patients were randomly assigned, in a 3:3:3:1:1:1 ratio, to receive once-daily subcutaneous semaglutide at a dose of 0.1, 0.2, or 0.4 mg or corresponding placebo.
Report a problemFND-3318536410

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

Registered trials3

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

3 trials · 2 ongoing · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

Active, not recruitingPhase 2NCT07466017

A Study of CS060380 Tablets in Patients With MASH and Obesity

Cascade Pharmaceuticals, Incn = 1302 Apr 2026 to est. 30 Jul 2027

Metabolic Dysfunction-associated Steatohepatitis (MASH) · Obesity

Trial page ClinicalTrials.govUpdated 10 Aug 2026

RecruitingNot applicableNCT06060392

Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus

Medanta, The Medicity, Indian = 5030 Oct 2023 to est. 1 Nov 2025

Liver Transplant; Complications · Diabete Mellitus

Trial page ClinicalTrials.govUpdated 13 Jun 2025

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
9 Oct 2026, 18:17 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

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