Safety and Efficacy of Efruxifermin in Combination With a GLP-1 Receptor Agonist in Patients With NASH/MASH and Type 2 Diabetes in a Randomized Phase 2 Study.

Harrison SA, Frias JP, Lucas KJ, Reiss G, Neff G, Bollepalli S, Su Y, Chan D, Tillman EJ, Moulton A, de Temple B, Zari A and 4 more

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Shringarpure R, Rolph T, Cheng A, Yale K

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association4 Mar 2024Cited by 81 (Europe PMC)

PMID38447814DOI10.1016/j.cgh.2024.02.022PepBankPUB-38447814

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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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study22

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

Studies that did not test the peptide alone22

In this study, the peptide 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 the peptide.

01HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included semaglutide, the efruxifermin-plus-GLP-1RA regimen appeared safe and well tolerated.
In plain wordsIn a mixed GLP-1 study including semaglutide, the efruxifermin combination appeared safe and well tolerated.
Peptide
Semaglutide
Outcome
Direction not reportedSafety and tolerability
Study
n = 21
Analysis
Primary
Outcome group
Adverse events · Whole body
Source sentences
Summary
The addition of efruxifermin to a GLP-1RA appeared safe and well-tolerated.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
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.
Report a problemFND-3844781403
02HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included liraglutide, the efruxifermin-plus-GLP-1RA regimen appeared safe and well tolerated.
In plain wordsIn a mixed GLP-1 study including liraglutide, the efruxifermin combination appeared safe and well tolerated.
Peptide
Liraglutide
Outcome
Direction not reportedSafety and tolerability
Study
n = 21
Analysis
Primary
Outcome group
Adverse events · Whole body
Source sentences
Summary
The addition of efruxifermin to a GLP-1RA appeared safe and well-tolerated.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
In this study, Liraglutide 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 Liraglutide.
Report a problemFND-3844781404
03HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included semaglutide, the most frequent efruxifermin-related adverse events were mild to moderate gastrointestinal events.
In plain wordsIn a mixed GLP-1 study including semaglutide, the most frequent efruxifermin-related side effects were mild to moderate digestive events.
Peptide
Semaglutide
Outcome
Not applicableEfruxifermin-related gastrointestinal adverse events
Study
n = 21
Analysis
Primary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Source sentences
Summary
The most frequent efruxifermin-related adverse events were mild to moderate gastrointestinal events.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
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.
Report a problemFND-3844781405
04HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included liraglutide, the most frequent efruxifermin-related adverse events were mild to moderate gastrointestinal events.
In plain wordsIn a mixed GLP-1 study including liraglutide, the most frequent efruxifermin-related side effects were mild to moderate digestive events.
Peptide
Liraglutide
Outcome
Not applicableEfruxifermin-related gastrointestinal adverse events
Study
n = 21
Analysis
Primary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Source sentences
Summary
The most frequent efruxifermin-related adverse events were mild to moderate gastrointestinal events.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
In this study, Liraglutide 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 Liraglutide.
Report a problemFND-3844781406
05HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included semaglutide, one efruxifermin recipient discontinued due to nausea.
In plain wordsIn a mixed GLP-1 study including semaglutide, one efruxifermin recipient stopped because of nausea.
Peptide
Semaglutide
Outcome
Not applicableDiscontinuation due to nausea
Study
n = 21
Analysis
Primary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Measurements
Discontinuations
1 patients
due to nausea
Source sentences
Summary
One patient receiving efruxifermin discontinued due to nausea, and another withdrew consent.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
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.
Report a problemFND-3844781407
06HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included liraglutide, one efruxifermin recipient discontinued due to nausea.
In plain wordsIn a mixed GLP-1 study including liraglutide, one efruxifermin recipient stopped because of nausea.
Peptide
Liraglutide
Outcome
Not applicableDiscontinuation due to nausea
Study
n = 21
Analysis
Primary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Measurements
Discontinuations
1 patients
due to nausea
Source sentences
Summary
One patient receiving efruxifermin discontinued due to nausea, and another withdrew consent.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
In this study, Liraglutide 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 Liraglutide.
Report a problemFND-3844781408
07HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included semaglutide, no treatment-related serious adverse events occurred.
In plain wordsIn a mixed GLP-1 study including semaglutide, no treatment-related serious side effects occurred.
Peptide
Semaglutide
Outcome
Not applicableTreatment-related serious adverse events
Study
n: not reported in source
Analysis
Primary
Outcome group
Adverse events · Whole body
Source sentences
Summary
There were no treatment-related serious adverse events.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
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.
Report a problemFND-3844781409
08HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included liraglutide, no treatment-related serious adverse events occurred.
In plain wordsIn a mixed GLP-1 study including liraglutide, no treatment-related serious side effects occurred.
Peptide
Liraglutide
Outcome
Not applicableTreatment-related serious adverse events
Study
n: not reported in source
Analysis
Primary
Outcome group
Adverse events · Whole body
Source sentences
Summary
There were no treatment-related serious adverse events.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
In this study, Liraglutide 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 Liraglutide.
Report a problemFND-3844781410
09HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included semaglutide, hepatic fat fraction fell by 65% with efruxifermin versus 10% with placebo plus GLP-1RA alone at 12 weeks (P < .0001).
In plain wordsIn a mixed GLP-1 study including semaglutide, added efruxifermin reduced liver fat more than placebo plus GLP-1RA therapy.
Peptide
Semaglutide
Outcome
DecreaseHepatic fat fraction
Study
n = 31
Comparator
Placebo plus GLP-1RA alone
Analysis
Secondary
Outcome group
Liver fat and liver function · Liver
Measurements
Hepatic fat fraction reduction
65%
efruxifermin; P < .0001 vs placebo
Hepatic fat fraction reduction
10%
placebo plus GLP-1RA alone
Source sentences
Summary
After 12 weeks, efruxifermin reduced HFF by 65% (P < .0001 vs placebo) compared with a 10% reduction for placebo (GLP-1RA alone).
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
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.
Report a problemFND-3844781411
10HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included liraglutide, hepatic fat fraction fell by 65% with efruxifermin versus 10% with placebo plus GLP-1RA alone at 12 weeks (P < .0001).
In plain wordsIn a mixed GLP-1 study including liraglutide, added efruxifermin reduced liver fat more than placebo plus GLP-1RA therapy.
Peptide
Liraglutide
Outcome
DecreaseHepatic fat fraction
Study
n = 31
Comparator
Placebo plus GLP-1RA alone
Analysis
Secondary
Outcome group
Liver fat and liver function · Liver
Measurements
Hepatic fat fraction reduction
65%
efruxifermin; P < .0001 vs placebo
Hepatic fat fraction reduction
10%
placebo plus GLP-1RA alone
Source sentences
Summary
After 12 weeks, efruxifermin reduced HFF by 65% (P < .0001 vs placebo) compared with a 10% reduction for placebo (GLP-1RA alone).
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
In this study, Liraglutide 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 Liraglutide.
Report a problemFND-3844781412
11HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included semaglutide, added efruxifermin maintained GLP-1RA-mediated weight loss.
In plain wordsIn a mixed GLP-1 study including semaglutide, added efruxifermin maintained weight loss.
Peptide
Semaglutide
Outcome
Not applicableGLP-1RA-mediated weight loss
Study
n: not reported in source
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Source sentences
Summary
Efruxifermin also improved noninvasive markers of liver injury, fibrosis, glucose, and lipid metabolism while maintaining GLP-1RA-mediated weight loss.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
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.
Report a problemFND-3844781401
12HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included liraglutide, added efruxifermin maintained GLP-1RA-mediated weight loss.
In plain wordsIn a mixed GLP-1 study including liraglutide, added efruxifermin maintained weight loss.
Peptide
Liraglutide
Outcome
Not applicableGLP-1RA-mediated weight loss
Study
n: not reported in source
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Source sentences
Summary
Efruxifermin also improved noninvasive markers of liver injury, fibrosis, glucose, and lipid metabolism while maintaining GLP-1RA-mediated weight loss.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
In this study, Liraglutide 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 Liraglutide.
Report a problemFND-3844781402
13HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included semaglutide, added efruxifermin improved noninvasive liver-injury markers; signed changes and the exact reference were unstated.
In plain wordsIn a mixed GLP-1 study including semaglutide, added efruxifermin improved noninvasive liver-injury markers; the comparison was unspecified.
Peptide
Semaglutide
Outcome
Direction not reportedMarkers of liver injury
Study
n: not reported in source
Analysis
Secondary
Outcome group
Liver fat and liver function · Liver
Source sentences
Summary
Efruxifermin also improved noninvasive markers of liver injury, fibrosis, glucose, and lipid metabolism while maintaining GLP-1RA-mediated weight loss.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
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.
Report a problemFND-3844781413
14HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included liraglutide, added efruxifermin improved noninvasive liver-injury markers; signed changes and the exact reference were unstated.
In plain wordsIn a mixed GLP-1 study including liraglutide, added efruxifermin improved noninvasive liver-injury markers; the comparison was unspecified.
Peptide
Liraglutide
Outcome
Direction not reportedMarkers of liver injury
Study
n: not reported in source
Analysis
Secondary
Outcome group
Liver fat and liver function · Liver
Source sentences
Summary
Efruxifermin also improved noninvasive markers of liver injury, fibrosis, glucose, and lipid metabolism while maintaining GLP-1RA-mediated weight loss.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
In this study, Liraglutide 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 Liraglutide.
Report a problemFND-3844781414
15HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included semaglutide, added efruxifermin improved noninvasive fibrosis markers; signed changes and the exact reference were unstated.
In plain wordsIn a mixed GLP-1 study including semaglutide, added efruxifermin improved noninvasive fibrosis markers; the comparison was unspecified.
Peptide
Semaglutide
Outcome
Direction not reportedMarkers of fibrosis
Study
n: not reported in source
Analysis
Secondary
Outcome group
Liver fat and liver function · Liver
Source sentences
Summary
Efruxifermin also improved noninvasive markers of liver injury, fibrosis, glucose, and lipid metabolism while maintaining GLP-1RA-mediated weight loss.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
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.
Report a problemFND-3844781415
16HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included liraglutide, added efruxifermin improved noninvasive fibrosis markers; signed changes and the exact reference were unstated.
In plain wordsIn a mixed GLP-1 study including liraglutide, added efruxifermin improved noninvasive fibrosis markers; the comparison was unspecified.
Peptide
Liraglutide
Outcome
Direction not reportedMarkers of fibrosis
Study
n: not reported in source
Analysis
Secondary
Outcome group
Liver fat and liver function · Liver
Source sentences
Summary
Efruxifermin also improved noninvasive markers of liver injury, fibrosis, glucose, and lipid metabolism while maintaining GLP-1RA-mediated weight loss.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
In this study, Liraglutide 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 Liraglutide.
Report a problemFND-3844781416
17HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included semaglutide, added efruxifermin improved glucose markers; signed changes and the exact reference were unstated.
In plain wordsIn a mixed GLP-1 study including semaglutide, added efruxifermin improved glucose markers; the comparison was unspecified.
Peptide
Semaglutide
Outcome
Direction not reportedGlucose markers
Study
n: not reported in source
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
Efruxifermin also improved noninvasive markers of liver injury, fibrosis, glucose, and lipid metabolism while maintaining GLP-1RA-mediated weight loss.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
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.
Report a problemFND-3844781417
18HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included liraglutide, added efruxifermin improved glucose markers; signed changes and the exact reference were unstated.
In plain wordsIn a mixed GLP-1 study including liraglutide, added efruxifermin improved glucose markers; the comparison was unspecified.
Peptide
Liraglutide
Outcome
Direction not reportedGlucose markers
Study
n: not reported in source
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
Efruxifermin also improved noninvasive markers of liver injury, fibrosis, glucose, and lipid metabolism while maintaining GLP-1RA-mediated weight loss.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
In this study, Liraglutide 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 Liraglutide.
Report a problemFND-3844781418
19HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included semaglutide, added efruxifermin improved lipid-metabolism markers; signed changes and the exact reference were unstated.
In plain wordsIn a mixed GLP-1 study including semaglutide, added efruxifermin improved lipid-metabolism markers; the comparison was unspecified.
Peptide
Semaglutide
Outcome
Direction not reportedLipid metabolism markers
Study
n: not reported in source
Analysis
Secondary
Outcome group
Lipids · Metabolic and weight
Source sentences
Summary
Efruxifermin also improved noninvasive markers of liver injury, fibrosis, glucose, and lipid metabolism while maintaining GLP-1RA-mediated weight loss.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
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.
Report a problemFND-3844781419
20HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome
In adults with T2D and MASH in a pooled GLP-1RA study whose overall background therapies included liraglutide, added efruxifermin improved lipid-metabolism markers; signed changes and the exact reference were unstated.
In plain wordsIn a mixed GLP-1 study including liraglutide, added efruxifermin improved lipid-metabolism markers; the comparison was unspecified.
Peptide
Liraglutide
Outcome
Direction not reportedLipid metabolism markers
Study
n: not reported in source
Analysis
Secondary
Outcome group
Lipids · Metabolic and weight
Source sentences
Summary
Efruxifermin also improved noninvasive markers of liver injury, fibrosis, glucose, and lipid metabolism while maintaining GLP-1RA-mediated weight loss.
4 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA.
Summary · context
Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
In this study, Liraglutide 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 Liraglutide.
Report a problemFND-3844781420
21HumanNot a test of Semaglutide aloneRandomized controlled trialOther
In adults with T2D and MASH in a pooled GLP-1RA study whose overall therapies included semaglutide, one efruxifermin recipient withdrew consent.
In plain wordsIn a mixed GLP-1 study including semaglutide, one efruxifermin recipient withdrew consent.
Peptide
Semaglutide
Outcome
Not applicableWithdrawal of consent
Study
n = 21
Outcome group
Treatment adherence and retention · Whole body
Source sentences
Summary
One patient receiving efruxifermin discontinued due to nausea, and another withdrew consent.
2 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
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.
Report a problemFND-3844781421
22HumanNot a test of Liraglutide aloneRandomized controlled trialOther
In adults with T2D and MASH in a pooled GLP-1RA study whose overall therapies included liraglutide, one efruxifermin recipient withdrew consent.
In plain wordsIn a mixed GLP-1 study including liraglutide, one efruxifermin recipient withdrew consent.
Peptide
Liraglutide
Outcome
Not applicableWithdrawal of consent
Study
n = 21
Outcome group
Treatment adherence and retention · Whole body
Source sentences
Summary
One patient receiving efruxifermin discontinued due to nausea, and another withdrew consent.
2 context sentences(design, population, supporting numbers)
Summary · context
Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks.
Summary · context
Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks.
In this study, Liraglutide 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 Liraglutide.
Report a problemFND-3844781422

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

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.

Versions 5 to 10Current
28 Oct 2026, 02:03 UTC
The same notice was added 6 times, first on 22 Oct 2026, 02:26 UTC. The status did not change between them.
Study results updated
Version 4
21 Oct 2026, 18:59 UTC
Study data updated · source update from Europe PMC
Version 3
12 Oct 2026, 11:11 UTC
Study results updated
Version 2
9 Oct 2026, 03:06 UTC
Study data updated · source update from Europe PMC
Version 1
9 Oct 2026, 03:05 UTC
First added · source update from Europe PMC

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Safety and Efficacy of Efruxifermin in Combination With a GLP-1 Receptor Agonist in Patients With NASH/MASH and Type 2 Diabetes in a Randomized Phase 2 Study.

Summary

Results from this study22

Studies that did not test the peptide alone22

Version history

Subjects

Publication types

MeSH terms

Keywords