New England Journal of Medicine,
Год журнала:
2024,
Номер
390(6), С. 497 - 509
Опубликована: Фев. 7, 2024
Nonalcoholic
steatohepatitis
(NASH)
is
a
progressive
liver
disease
with
no
approved
treatment.
Resmetirom
an
oral,
liver-directed,
thyroid
hormone
receptor
beta–selective
agonist
in
development
for
the
treatment
of
NASH
fibrosis.
Download
PDF
Research
Summary.
We
are
conducting
ongoing
phase
3
trial
involving
adults
biopsy-confirmed
and
fibrosis
stage
F1B,
F2,
or
F3
(stages
range
from
F0
[no
fibrosis]
to
F4
[cirrhosis]).
Patients
were
randomly
assigned
1:1:1
ratio
receive
once-daily
resmetirom
at
dose
80
mg
100
placebo.
The
two
primary
end
points
week
52
resolution
(including
reduction
nonalcoholic
fatty
[NAFLD]
activity
score
by
≥2
points;
scores
0
8,
higher
indicating
more
severe
disease)
worsening
fibrosis,
improvement
(reduction)
least
one
NAFLD
score.
Overall,
966
patients
formed
analysis
population
(322
80-mg
group,
323
100-mg
321
placebo
group).
was
achieved
25.9%
group
29.9%
those
as
compared
9.7%
(P<0.001
both
comparisons
placebo).
Fibrosis
24.2%
14.2%
change
low-density
lipoprotein
cholesterol
levels
baseline
24
−13.6%
−16.3%
0.1%
Diarrhea
nausea
frequent
than
incidence
serious
adverse
events
similar
across
groups:
10.9%
12.7%
11.5%
group.
Both
superior
respect
stage.
(Funded
Madrigal
Pharmaceuticals;
MAESTRO-NASH
ClinicalTrials.gov
number,
NCT03900429.)
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SUMMARYResmetirom
Liver
02:17
Hepatology,
Год журнала:
2018,
Номер
69(6), С. 2672 - 2682
Опубликована: Сен. 4, 2018
Over
the
past
2
decades,
nonalcoholic
fatty
liver
disease
(NAFLD)
has
grown
from
a
relatively
unknown
to
most
common
cause
of
chronic
in
world.
In
fact,
25%
world’s
population
is
currently
thought
have
NAFLD.
Nonalcoholic
steatohepatitis
(NASH)
subtype
NAFLD
that
can
progress
cirrhosis,
hepatocellular
carcinoma
(HCC),
and
death.
NASH
are
not
only
found
adults—there
also
high
prevalence
these
diseases
children
adolescents.
Because
close
association
with
type
diabetes
(T2DM)
obesity,
latest
models
predict
will
increase,
causing
tremendous
clinical
economic
burden
poor
patient‐reported
outcomes.
Nonetheless,
there
no
accurate
noninvasive
method
detect
NASH,
treatment
this
limited
lifestyle
modifications.
To
examine
state
among
different
regions
understand
global
trajectory
disease,
an
international
group
experts
came
together
during
2017
American
Association
for
Study
Liver
Diseases
Global
Forum.
We
provide
summary
forum
assessment
current
worldwide.
New England Journal of Medicine,
Год журнала:
2020,
Номер
384(12), С. 1113 - 1124
Опубликована: Ноя. 13, 2020
Nonalcoholic
steatohepatitis
(NASH)
is
a
common
disease
that
associated
with
increased
morbidity
and
mortality,
but
treatment
options
are
limited.
The
efficacy
safety
of
the
glucagon-like
peptide-1
receptor
agonist
semaglutide
in
patients
NASH
not
known.We
conducted
72-week,
double-blind
phase
2
trial
involving
biopsy-confirmed
liver
fibrosis
stage
F1,
F2,
or
F3.
Patients
were
randomly
assigned,
3:3:3:1:1:1
ratio,
to
receive
once-daily
subcutaneous
at
dose
0.1,
0.2,
0.4
mg
corresponding
placebo.
primary
end
point
was
resolution
no
worsening
fibrosis.
confirmatory
secondary
an
improvement
least
one
NASH.
analyses
these
points
performed
only
F2
F3
fibrosis;
other
all
patients.In
total,
320
(of
whom
230
had
fibrosis)
assigned
0.1
(80
patients),
0.2
(78
(82
patients)
placebo
patients).
percentage
achieved
40%
0.1-mg
group,
36%
0.2-mg
59%
0.4-mg
17%
group
(P<0.001
for
vs.
placebo).
An
occurred
43%
33%
(P
=
0.48).
mean
percent
weight
loss
13%
1%
group.
incidence
nausea,
constipation,
vomiting
higher
than
(nausea,
42%
11%;
22%
12%;
vomiting,
15%
2%).
Malignant
neoplasms
reported
3
who
received
(1%)
Overall,
(benign,
malignant,
unspecified)
groups
8%
group;
pattern
occurrence
specific
organs
observed.This
showed
resulted
significantly
However,
did
show
significant
between-group
difference
stage.
(Funded
by
Novo
Nordisk;
ClinicalTrials.gov
number,
NCT02970942.).
