Resmetirom Reduces Hepatic Fat, Lipid Levels in Patients With Hypothyroidism and Nonalcoholic Steatohepatitis

Microscopic photo of a professionally prepared slide demonstrating macrovesicular steatosis of the liver (fatty liver disease), hepatic steatosis, metabolic syndrome. Can be ssociated with nonalcoholic fatty liver disease (NAFLD) or Alcoholic Liver Disease (ALD). H&E stain.
Investigators report results from MAESTRO-NAFLD-1, a phase 3, randomized, double-blind, placebo-controlled trial evaluating the effect of treatment with resmetirom in patients with hypothyroidism and nonalcoholic steatohepatitis.

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Resmetirom therapy resulted in reduced hepatic fat and low-density lipoprotein cholesterol levels among patients with hypothyroidism and nonalcoholic fatty liver disease, according to study results presented at the 30th Annual Scientific and Clinical Congress of the American Association of Clinical Endocrinology (ENVISION 2021).

Patients (N=700) with at least 3 metabolic risk factors were recruited at 65 sites in the United States for this phase 3 clinical trial. Patients in the active open-label arm (n=176) with nonalcoholic steatohepatitis (NASH) received resmetirom 00 mg daily for 52 weeks and were evaluated for magnetic resonance imaging proton density fat fraction (MRI-PDFF) and lipid levels.

The mean age of patients with hypothyroidism (n=76) was 58.9  years; 82% were women, mean BMI was 36.2 kg/m2, 54% had diabetes, and 71% had hypertension. The mean age of patients who did not have hypothyroidism (n=100) was 53.2 years; 56% were women, mean BMI was 36.1 kg/m2, 45% had diabetes, and 67% had hypertension. At baseline, patients with hypothyroidism were significantly older (P =.00081) and had higher MR elastography (P =.032), free thyroxine (P <.0001), free triiodothyronine (FT3; P =.0006), reverse T3 (rT3; P <.0002), and FT3/rT3 ratio (P <.0001).

At week 16, MRI-PDFF decreased by 53% (P <.0001) and MRE by 0.34 kPa (P =.003) from baseline values.

The hypothyroid and nonhypothyroid subgroups had decreases of 24.1% and 23.2% for low-density lipoprotein cholesterol, 25.8% and 23.9% for apolipoprotein B, 19.5% and 25.6% for triglycerides, 24.1% and 26.3% for non-high-density lipoprotein cholesterol, and 20.9% and 35.7% for lipoprotein(a), respectively (all P £.002).

Resmetirom therapy was associated with significant decreases in heart rate (-2.8 bpm; P .015), systolic blood pressure (-3.8 mm Hg; P =.0003), and diastolic blood pressure (-2.9 mmHg; P =.0022) from baseline values.

Treatment-emergent adverse events occurred among 61% of patients, and 1 patient reported a serious event.

This study may have been biased by the open-label design.

These data indicate that daily resmetirom decreased hepatic fat and lipid levels among patients with NASH.

Disclosure: Multiple authors declared affiliations with the pharmaceutical industry. Please refer to the original article for a full list of disclosures.

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Lucas J, Harrison S, Baum S, Abdelmalek M, Taub R. Treatment of hypothyroid patients with nonalcoholic fatty liver disease with resmetirom, a selective thyroid hormone receptor beta agonist. Presented at: 2021 Virtual AACE Annual Meeting 2021, May 26-29, 2021.