A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis.

Sanyal AJ, Bedossa P, Fraessdorf M, Neff GW, Lawitz E, Bugianesi E, Anstee QM, Hussain SA, Newsome PN, Ratziu V, Hosseini-Tabatabaei A, Schattenberg JM, Noureddin M, Alkhouri N, Younes R

The New England journal of medicine7 Jun 2024Cited by 426 (Europe PMC)

PMID38847460DOI10.1056/nejmoa2401755PepBankPUB-38847460

Publisher page PubMedAsk about this study

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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 study13

13 results from studies that gave the peptide. 13 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with biopsy-confirmed MASH and fibrosis F1-F3, 47% on survodutide 2.4 mg had MASH improvement without worsening of fibrosis, versus 14% on placebo.
In plain wordsIn adults with MASH, more people improved on survodutide 2.4 mg (47%) than on placebo (14%).
Peptide
Survodutide
Outcome
IncreaseMASH improvement without worsening of fibrosis (2.4 mg)
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Liver fat and liver function · Liver
Studied dose
2.4 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
MASH improvement responders
47%
survodutide 2.4 mg
MASH improvement responders
14%
placebo
Source sentences
Summary
Improvement in MASH with no worsening of fibrosis occurred in 47% of the participants in the survodutide 2.4-mg group, 62% of those in the 4.8-mg group, and 43% of those in the 6.0-mg group, as compared with 14% of those in the placebo group (P<0.001 for the quadratic dose-response curve as best-fitting model).
1 context sentence(design, population, supporting numbers)
Summary · context
In this 48-week, phase 2 trial, we randomly assigned adults with biopsy-confirmed MASH and fibrosis stage F1 through F3 in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of survodutide at a dose of 2.4, 4.8, or 6.0 mg or placebo.
Report a problemFND-3884746001
02HumanRandomized controlled trialEfficacy outcome
In adults with biopsy-confirmed MASH and fibrosis F1-F3, 62% on survodutide 4.8 mg had MASH improvement without worsening of fibrosis, versus 14% on placebo.
In plain wordsIn adults with MASH, more people improved on survodutide 4.8 mg (62%) than on placebo (14%).
Peptide
Survodutide
Outcome
IncreaseMASH improvement without worsening of fibrosis (4.8 mg)
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Liver fat and liver function · Liver
Studied dose
4.8 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
MASH improvement responders
62%
survodutide 4.8 mg
MASH improvement responders
14%
placebo
Source sentences
Summary
Improvement in MASH with no worsening of fibrosis occurred in 47% of the participants in the survodutide 2.4-mg group, 62% of those in the 4.8-mg group, and 43% of those in the 6.0-mg group, as compared with 14% of those in the placebo group (P<0.001 for the quadratic dose-response curve as best-fitting model).
1 context sentence(design, population, supporting numbers)
Summary · context
In this 48-week, phase 2 trial, we randomly assigned adults with biopsy-confirmed MASH and fibrosis stage F1 through F3 in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of survodutide at a dose of 2.4, 4.8, or 6.0 mg or placebo.
Report a problemFND-3884746002
03HumanRandomized controlled trialEfficacy outcome
In adults with biopsy-confirmed MASH and fibrosis F1-F3, 43% on survodutide 6.0 mg had MASH improvement without worsening of fibrosis, versus 14% on placebo.
In plain wordsIn adults with MASH, more people improved on survodutide 6.0 mg (43%) than on placebo (14%).
Peptide
Survodutide
Outcome
IncreaseMASH improvement without worsening of fibrosis (6.0 mg)
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Liver fat and liver function · Liver
Studied dose
6.0 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
MASH improvement responders
43%
survodutide 6.0 mg
MASH improvement responders
14%
placebo
Source sentences
Summary
Improvement in MASH with no worsening of fibrosis occurred in 47% of the participants in the survodutide 2.4-mg group, 62% of those in the 4.8-mg group, and 43% of those in the 6.0-mg group, as compared with 14% of those in the placebo group (P<0.001 for the quadratic dose-response curve as best-fitting model).
1 context sentence(design, population, supporting numbers)
Summary · context
In this 48-week, phase 2 trial, we randomly assigned adults with biopsy-confirmed MASH and fibrosis stage F1 through F3 in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of survodutide at a dose of 2.4, 4.8, or 6.0 mg or placebo.
Report a problemFND-3884746003
04HumanRandomized controlled trialEfficacy outcome
In adults with MASH, 63% on survodutide 2.4 mg had a liver fat decrease of at least 30%, versus 14% on placebo.
In plain wordsIn adults with MASH, liver fat fell by at least 30% in 63% on survodutide 2.4 mg and 14% on placebo.
Peptide
Survodutide
Outcome
IncreaseLiver fat decrease of at least 30% (2.4 mg)
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Liver fat and liver function · Liver
Studied dose
2.4 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Liver fat decrease >=30% responders
63%
survodutide 2.4 mg
Liver fat decrease >=30% responders
14%
placebo
Source sentences
Summary
A decrease in liver fat content by at least 30% occurred in 63% of the participants in the survodutide 2.4-mg group, 67% of those in the 4.8-mg group, 57% of those in the 6.0-mg group, and 14% of those in the placebo group; improvement in fibrosis by at least one stage occurred in 34%, 36%, 34%, and 22%, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 48-week, phase 2 trial, we randomly assigned adults with biopsy-confirmed MASH and fibrosis stage F1 through F3 in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of survodutide at a dose of 2.4, 4.8, or 6.0 mg or placebo.
Report a problemFND-3884746004
05HumanRandomized controlled trialEfficacy outcome
In adults with MASH, 67% on survodutide 4.8 mg had a liver fat decrease of at least 30%, versus 14% on placebo.
In plain wordsIn adults with MASH, liver fat fell by at least 30% in 67% on survodutide 4.8 mg and 14% on placebo.
Peptide
Survodutide
Outcome
IncreaseLiver fat decrease of at least 30% (4.8 mg)
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Liver fat and liver function · Liver
Studied dose
4.8 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Liver fat decrease >=30% responders
67%
survodutide 4.8 mg
Liver fat decrease >=30% responders
14%
placebo
Source sentences
Summary
A decrease in liver fat content by at least 30% occurred in 63% of the participants in the survodutide 2.4-mg group, 67% of those in the 4.8-mg group, 57% of those in the 6.0-mg group, and 14% of those in the placebo group; improvement in fibrosis by at least one stage occurred in 34%, 36%, 34%, and 22%, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 48-week, phase 2 trial, we randomly assigned adults with biopsy-confirmed MASH and fibrosis stage F1 through F3 in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of survodutide at a dose of 2.4, 4.8, or 6.0 mg or placebo.
Report a problemFND-3884746005
06HumanRandomized controlled trialEfficacy outcome
In adults with MASH, 57% on survodutide 6.0 mg had a liver fat decrease of at least 30%, versus 14% on placebo.
In plain wordsIn adults with MASH, liver fat fell by at least 30% in 57% on survodutide 6.0 mg and 14% on placebo.
Peptide
Survodutide
Outcome
IncreaseLiver fat decrease of at least 30% (6.0 mg)
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Liver fat and liver function · Liver
Studied dose
6.0 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Liver fat decrease >=30% responders
57%
survodutide 6.0 mg
Liver fat decrease >=30% responders
14%
placebo
Source sentences
Summary
A decrease in liver fat content by at least 30% occurred in 63% of the participants in the survodutide 2.4-mg group, 67% of those in the 4.8-mg group, 57% of those in the 6.0-mg group, and 14% of those in the placebo group; improvement in fibrosis by at least one stage occurred in 34%, 36%, 34%, and 22%, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 48-week, phase 2 trial, we randomly assigned adults with biopsy-confirmed MASH and fibrosis stage F1 through F3 in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of survodutide at a dose of 2.4, 4.8, or 6.0 mg or placebo.
Report a problemFND-3884746006
07HumanRandomized controlled trialEfficacy outcome
In adults with MASH, fibrosis improved by at least one stage in 34% on survodutide 2.4 mg and 22% on placebo; significance was not stated.
In plain wordsIn adults with MASH, liver scarring improved by one stage or more in 34% on survodutide 2.4 mg and 22% on placebo.
Peptide
Survodutide
Outcome
Direction not reportedFibrosis improvement of at least one stage (2.4 mg)
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Liver fat and liver function · Liver
Studied dose
2.4 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Fibrosis improvement responders
34%
survodutide 2.4 mg
Fibrosis improvement responders
22%
placebo
Source sentences
Summary
A decrease in liver fat content by at least 30% occurred in 63% of the participants in the survodutide 2.4-mg group, 67% of those in the 4.8-mg group, 57% of those in the 6.0-mg group, and 14% of those in the placebo group; improvement in fibrosis by at least one stage occurred in 34%, 36%, 34%, and 22%, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 48-week, phase 2 trial, we randomly assigned adults with biopsy-confirmed MASH and fibrosis stage F1 through F3 in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of survodutide at a dose of 2.4, 4.8, or 6.0 mg or placebo.
Report a problemFND-3884746007
08HumanRandomized controlled trialEfficacy outcome
In adults with MASH, fibrosis improved by at least one stage in 36% on survodutide 4.8 mg and 22% on placebo; significance was not stated.
In plain wordsIn adults with MASH, liver scarring improved by one stage or more in 36% on survodutide 4.8 mg and 22% on placebo.
Peptide
Survodutide
Outcome
Direction not reportedFibrosis improvement of at least one stage (4.8 mg)
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Liver fat and liver function · Liver
Studied dose
4.8 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Fibrosis improvement responders
36%
survodutide 4.8 mg
Fibrosis improvement responders
22%
placebo
Source sentences
Summary
A decrease in liver fat content by at least 30% occurred in 63% of the participants in the survodutide 2.4-mg group, 67% of those in the 4.8-mg group, 57% of those in the 6.0-mg group, and 14% of those in the placebo group; improvement in fibrosis by at least one stage occurred in 34%, 36%, 34%, and 22%, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 48-week, phase 2 trial, we randomly assigned adults with biopsy-confirmed MASH and fibrosis stage F1 through F3 in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of survodutide at a dose of 2.4, 4.8, or 6.0 mg or placebo.
Report a problemFND-3884746008
09HumanRandomized controlled trialEfficacy outcome
In adults with MASH, fibrosis improved by at least one stage in 34% on survodutide 6.0 mg and 22% on placebo; significance was not stated.
In plain wordsIn adults with MASH, liver scarring improved by one stage or more in 34% on survodutide 6.0 mg and 22% on placebo.
Peptide
Survodutide
Outcome
Direction not reportedFibrosis improvement of at least one stage (6.0 mg)
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Liver fat and liver function · Liver
Studied dose
6.0 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Fibrosis improvement responders
34%
survodutide 6.0 mg
Fibrosis improvement responders
22%
placebo
Source sentences
Summary
A decrease in liver fat content by at least 30% occurred in 63% of the participants in the survodutide 2.4-mg group, 67% of those in the 4.8-mg group, 57% of those in the 6.0-mg group, and 14% of those in the placebo group; improvement in fibrosis by at least one stage occurred in 34%, 36%, 34%, and 22%, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 48-week, phase 2 trial, we randomly assigned adults with biopsy-confirmed MASH and fibrosis stage F1 through F3 in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of survodutide at a dose of 2.4, 4.8, or 6.0 mg or placebo.
Report a problemFND-3884746009
10HumanRandomized controlled trialSafety outcome
In adults with MASH, nausea was more frequent with survodutide than with placebo (66% vs. 23%).
In plain wordsIn adults with MASH, nausea was more common with survodutide (66%) than with placebo (23%).
Peptide
Survodutide
Outcome
IncreaseNausea
Study
n = 293
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2.4, 4.8 or 6.0 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Nausea incidence
66%
survodutide
Nausea incidence
23%
placebo
Source sentences
Summary
Adverse events that were more frequent with survodutide than with placebo included nausea (66% vs. 23%), diarrhea (49% vs. 23%), and vomiting (41% vs. 4%); serious adverse events occurred in 8% with survodutide and 7% with placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 48-week, phase 2 trial, we randomly assigned adults with biopsy-confirmed MASH and fibrosis stage F1 through F3 in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of survodutide at a dose of 2.4, 4.8, or 6.0 mg or placebo.
Report a problemFND-3884746010
11HumanRandomized controlled trialSafety outcome
In adults with MASH, diarrhea was more frequent with survodutide than with placebo (49% vs. 23%).
In plain wordsIn adults with MASH, diarrhea was more common with survodutide (49%) than with placebo (23%).
Peptide
Survodutide
Outcome
IncreaseDiarrhea
Study
n = 293
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2.4, 4.8 or 6.0 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Diarrhea incidence
49%
survodutide
Diarrhea incidence
23%
placebo
Source sentences
Summary
Adverse events that were more frequent with survodutide than with placebo included nausea (66% vs. 23%), diarrhea (49% vs. 23%), and vomiting (41% vs. 4%); serious adverse events occurred in 8% with survodutide and 7% with placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 48-week, phase 2 trial, we randomly assigned adults with biopsy-confirmed MASH and fibrosis stage F1 through F3 in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of survodutide at a dose of 2.4, 4.8, or 6.0 mg or placebo.
Report a problemFND-3884746011
12HumanRandomized controlled trialSafety outcome
In adults with MASH, vomiting was more frequent with survodutide than with placebo (41% vs. 4%).
In plain wordsIn adults with MASH, vomiting was more common with survodutide (41%) than with placebo (4%).
Peptide
Survodutide
Outcome
IncreaseVomiting
Study
n = 293
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2.4, 4.8 or 6.0 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Vomiting incidence
41%
survodutide
Vomiting incidence
4%
placebo
Source sentences
Summary
Adverse events that were more frequent with survodutide than with placebo included nausea (66% vs. 23%), diarrhea (49% vs. 23%), and vomiting (41% vs. 4%); serious adverse events occurred in 8% with survodutide and 7% with placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 48-week, phase 2 trial, we randomly assigned adults with biopsy-confirmed MASH and fibrosis stage F1 through F3 in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of survodutide at a dose of 2.4, 4.8, or 6.0 mg or placebo.
Report a problemFND-3884746012
13HumanRandomized controlled trialSafety outcome
In adults with MASH, serious adverse events occurred in 8% with survodutide and 7% with placebo.
In plain wordsIn adults with MASH, serious side effects occurred in 8% on survodutide and 7% on placebo.
Peptide
Survodutide
Outcome
Direction not reportedSerious adverse events
Study
n = 293
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
2.4, 4.8 or 6.0 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Serious adverse events
8%
survodutide
Serious adverse events
7%
placebo
Source sentences
Summary
Adverse events that were more frequent with survodutide than with placebo included nausea (66% vs. 23%), diarrhea (49% vs. 23%), and vomiting (41% vs. 4%); serious adverse events occurred in 8% with survodutide and 7% with placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
In this 48-week, phase 2 trial, we randomly assigned adults with biopsy-confirmed MASH and fibrosis stage F1 through F3 in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of survodutide at a dose of 2.4, 4.8, or 6.0 mg or placebo.
Report a problemFND-3884746013

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 postedNCT04771273

A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)

Boehringer Ingelheimn = 29527 Apr 2021 to 21 Dec 2023

Non-alcoholic Steatohepatitis (NASH)

Trial page ClinicalTrials.govUpdated 3 Dec 2024

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, 19:08 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

MeSH terms

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