MAESTRO: First Treatment for NASH

Dr. Tashko offers holistic management for NAFLD and NASH in patients with diabetes, insulin resistance, and Metabolic Syndrome. His approach integrates personalized care, ensuring comprehensive evaluation and tailored strategies for each individual's needs, optimizing their health outcomes effectively and compassionately.

February 2024 NEJM / March 2024 FDA Approved

Background – Endocrinologist in the State of Maryland

As a board-certified endocrinologist with clinical and research training, I’m committed to staying abreast of the latest advancements to offer my community optimal care through personalized and integrative approaches.

Conveniently located in Rockville, my practice provides virtual and in-person services, extending support to nearby areas such as Chevy Chase, Bethesda, North Bethesda, Potomac, North Potomac, Gaithersburg, Germantown, Frederick, Silver Spring, Northern Virginia, Howard County, Anne Arundel, and the Eastern Shore of Maryland for comprehensive care.

Here, I introduce a summary of the MAESTRO study, which pioneered the first treatment for NASH patients. Without delay, let’s delve into the highlights and results published in the New England Journal of Medicine in February 2024, which led to FDA approval in March 2024.

MAESTRO Study Details and Results

Rezdiffra (Resmetirom), an oral medication targeting the liver and selective for thyroid hormone receptor β, demonstrated promising results. At doses of 80mg and 100mg, it achieved NASH resolution in 25% and 30% of participants, respectively, compared to just 10% in the placebo group. 

Furthermore, Resmetirom significantly reduced LDL cholesterol levels. Though adverse effects such as diarrhea and nausea were noted, serious events were similar across all groups.

The study cohort primarily consisted of individuals with obesity, diabetes, hypertension, and dyslipidemia, all of whom had a high risk of ASCVD.

The trial lasted approximately 52 weeks. Baseline characteristics were:

  • Number of patients per arm: 300
  • Age: 56 years
  • Male: 45%
  • Caucasian: 90%
  • BMI: 35
  • Diabetes: 65%
  • Hypertension: 75%
  • Dyslipidemia: 70%
  • 10-year ASCVD risk: 15%
  • LDLc: 105 mg/dL
  • ALT: 55 u/L
  • AST: 40 u/L
  • Biopsy F3 Stage: 60%

This phase 3 trial of Resmetirom for NASH treatment demonstrated significant efficacy at both 80mg and 100mg doses, with notable improvements in liver health and lipid profiles. Despite some adverse effects, the benefits outweigh the risks, marking a significant advancement in NASH management, officially FDA approved in March 2024.

Dr. Tashko

Dr. Tashko is an ABIM board-certified endocrinologist with additional certifications in lipidology, hypertension, and obesity medicine. He delivers personalized, holistic care to patients in Montgomery County, Maryland.