Primary data analyses of MAESTRO-NAFLD-1 a 52 week double-blind placebo-controlled phase 3 clinical trial of resmetirom in patients with NAFLD

Harrison, Stephen A.; Taub, Rebecca; Neff, Guy; Moussa, Sam; Alkhouri, Naim; Bashir, Mustafa R.

doi:10.1016/s0168-8278(22)00445-7

Cited by 15 publications

(13 citation statements)

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“…A phase 3 study on patients with non-invasive diagnosis of NAFLD showed that 100 mg of resmetiron administered daily for 52 weeks improved liver fat content in approximately 50% of treated patients vs 8% of placebo-treated patients; liver fibrosis in approximately 20% of treated patients vs. 10% of placebo-treated patients (both measured by a non-invasive test). Lipid metabolism parameters, liver enzymes, and inflammatory biomarkers also improved compared to placebo [61]. There were no major safety concerns.…”

Section: Thr Beta Agonistsmentioning

confidence: 80%

Metabolic dysfunction–associated fatty liver disease (MAFLD): an update of the recent advances in pharmacological treatment

et al. 2023

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Metabolic dysfunction–associated fatty liver disease (MAFLD) is nowadays considered the liver manifestation of metabolic syndrome. Its prevalence is increasing worldwide in parallel to the epidemic of diabetes and obesity. MAFLD includes a wide spectrum of liver injury including simple steatosis and non-alcoholic steatohepatitis (NASH) that may lead to serious complications such as liver cirrhosis and liver cancer. The complexity of its pathophysiology and the intricate mechanisms underlying disease progression explains the huge variety of molecules targeting diverse biological mechanisms that have been tested in preclinical and clinical settings in the last two decades. Thanks to the large number of clinical trials of the last few years, most of them still ongoing, the pharmacotherapy scenario of MAFLD is rapidly evolving. The three major components of MAFLD, steatosis, inflammation, and fibrosis seem to be safely targeted with different agents at least in a large proportion of patients. Likely, in the next few years more than one drug will be approved for the treatment of MAFLD at different disease stages. The aim of this review is to synthesize the characteristics and the results of the most advanced clinical trials for the treatment of NASH to evaluate the recent advances of pharmacotherapy in this disease.

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Section: Thr Beta Agonistsmentioning

confidence: 80%

Metabolic dysfunction–associated fatty liver disease (MAFLD): an update of the recent advances in pharmacological treatment

et al. 2023

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“…The preliminary results showed that resmetirom was efficacious for hepatic fat assessed using MRI-proton density fat fraction. 41 The most prevalent side effects were mild gastrointestinal symptoms, including diarrhea and nausea.…”

Section: Pan-ppar Agonistmentioning

confidence: 99%

“…An ongoing phase 3 MAESTRO-NAFLD1 trial is evaluating the impact of resmetirom on liver histology in patients with NASH and stage 2–3 fibrosis ( Table 2 ). The preliminary results showed that resmetirom was efficacious for hepatic fat assessed using MRI-proton density fat fraction [ 41 ]. The most prevalent side effects were mild gastrointestinal symptoms, including diarrhea and nausea.…”

Section: Future Pharmacologic Therapiesmentioning

confidence: 99%

Pharmacological advances in the treatment of nonalcoholic fatty liver diseases : focused on global results of randomized controlled trials

Sohn¹

2023

Clin Mol Hepatol

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Nonalcoholic fatty liver disease (NAFLD) is the most common cause of liver disease globally, and its prevalence is rapidly increasing. Nonalcoholic steatohepatitis (NASH), a progressive form of NAFLD, is characterized by hepatocellular injury, inflammation, and fibrosis. Patients with NASH or severe fibrosis should be treated according to international NAFLD guidelines. Currently, regulatory agencies have not approved any pharmaceutical treatment for NAFLD. Vitamin E and pioglitazone are efficacious for NASH resolution; however, their benefits must be weighed against the reported risks. In a phase 2 trial, a glucagon-like peptide-1 agonist commonly used for diabetes and obesity was found to improve liver histology in patients with NASH. Furthermore, therapeutic agents targeting NASH pathogenesis, including bile acid signaling, insulin resistance, and lipid metabolism, are in various phases of clinical development. In this article, we review the benefits and drawbacks of current pharmacotherapy and the efficacy of upcoming treatments for NASH.

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“…This oral medication has shown increased reduction of hepatic fat as measured by magnetic resonance imaging (MRI) in phase 2 clinical trials though a clear mortality benefit is not yet evident [ 61 ]. Phase 3 trials confirm that resmetirom is as safe and as well tolerated as placebo while significantly improving liver transaminases and fibrosis biomarkers in addition to proton-density fat fraction on MRI [ 62 ].…”

Section: Cardiovascular Diseasementioning

confidence: 99%

Nonalcoholic fatty liver disease and non-liver comorbidities

Manikat

Nguyen

2023

Clin Mol Hepatol

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Non-alcoholic fatty liver disease (NAFLD) is a chronic liver disease characterized by excess fat accumulation in the liver. It is closely associated with metabolic syndrome, and patients with NAFLD often have comorbidities such as obesity, type 2 diabetes mellitus, and dyslipidemia. In addition to liver-related complications, NAFLD has been associated with a range of non-liver comorbidities, including cardiovascular disease, chronic kidney disease, and sleep apnea. Cardiovascular disease is the most common cause of mortality in patients with NAFLD, and patients with NAFLD have a higher risk of developing cardiovascular disease than the general population. Chronic kidney disease is also more common in patients with NAFLD, and the severity of NAFLD is associated with a higher risk of developing chronic kidney disease. Sleep apnea, a disorder characterized by breathing interruptions during sleep, is also more common in patients with NAFLD and is associated with the severity of NAFLD. The presence of non-liver comorbidities in patients with NAFLD has important implications for the management of this disease. Treatment of comorbidities such as obesity, type 2 diabetes mellitus, and dyslipidemia may improve liver-related outcomes in patients with NAFLD. Moreover, treatment of non-liver comorbidities may also improve overall health outcomes in patients with NAFLD. Therefore, clinicians should be aware of the potential for non-liver comorbidities in patients with NAFLD and should consider the management of these comorbidities as part of the overall management of this disease.

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Primary data analyses of MAESTRO-NAFLD-1 a 52 week double-blind placebo-controlled phase 3 clinical trial of resmetirom in patients with NAFLD

Cited by 15 publications

References 0 publications

Metabolic dysfunction–associated fatty liver disease (MAFLD): an update of the recent advances in pharmacological treatment

Metabolic dysfunction–associated fatty liver disease (MAFLD): an update of the recent advances in pharmacological treatment

Pharmacological advances in the treatment of nonalcoholic fatty liver diseases : focused on global results of randomized controlled trials

Nonalcoholic fatty liver disease and non-liver comorbidities

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