Status and phase
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A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of denifanstat 50 mg compared to placebo in patients with metabolic dysfunction-associated steatotic liver disease (MALSD)/metabolic dysfunction-associated steatohepatitis (MASH) after 52 weeks of treatment.
Full description
Up to 2000 patients will be randomized to receive either denifanstat 50 mg or placebo.
Sex
Ages
Volunteers
Inclusion criteria
Willing and able to participate in the study and provide written informed consent.
Adults between 18 and 75 years of age.
Body mass index (BMI) ≥23 kg/m2 for Asian patients and ≥25 kg/m2 for patients of other races.
Presence of metabolic risk factor(s), as follows:
T2DM
OR
At least 2 out of 4 of the following:
For patients with T2DM:
HbA1c ≤9.5%
If treatment naive: patients must have been diagnosed for at least 12 weeks prior to screening
Suspected or confirmed diagnosis of MASH or MASLD or non-invasively diagnosed MASH or MASLD
Stable ALT and AST levels
Exclusion criteria
Previous intake of an approved MASH medication
Exclusionary laboratory values:
ALT and/or AST >5 × ULN.
ALP ≥2 × ULN.
Total serum bilirubin concentration >1.3 mg/dL.
Serum albumin concentration <3.5 g/dL.
International normalized ratio (INR) >1.3, except for patients receiving anticoagulant treatment.
Platelet count <140,000/μL.
Fasting TG level ≥500 mg/dL.
eGFR <45 mL/min/1.73 m2.
History of excessive alcohol intake for a period of more than 3 consecutive months within 1 year prior to screening.
Presence of cirrhosis on liver histology and/or cross-sectional imaging evidence consistent with cirrhosis and/or portal hypertension.
Current or historical clinically evident hepatic decompensation.
Evidence of another form of active liver disease.
Positive serologic evidence of current infectious liver disease.
MELD score ≥12.
Planned or history of liver transplantation.
Prior or planned bariatric surgery.
Gain or loss of >5% of body weight in the 3 months or >10% of body weight in the 6 months prior to screening, qualifying liver biopsy, and the baseline visit (V1).
Any of the following conditions or procedures within 6 months prior to the baseline visit (V1):
Myocardial infarction
Cardiac revascularization surgery
Unstable angina
Transient ischemic attack, stroke, or cerebrovascular disease
Unstable or undiagnosed arrhythmias.
Uncontrolled high BP.
Malignancy with a complete remission date within 5 years prior to the baseline visit (V1).
Any current or history of hepatocellular carcinoma.
Diabetes other than T2DM
Uncontrolled hypothyroidism.
Any other known serious disease or other disease which in the Investigator's opinion would exclude the patient from participating in the study.
Use of a nonpermitted concomitant medication within 30 days or 5 half-lives prior to screening.
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups, including a placebo group
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Central trial contact
Study Director
Data sourced from clinicaltrials.gov
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