Rezdiffra was evaluated in patient types typically seen in practice, including those with common comorbidities1,2

Baseline data in MAESTRO-NASH

Demographics and
comorbidities 		Placebo
(n=294) 		Rezdiffra
80 mg
(n=298) 		Rezdiffra
100 mg (n=296) 		Overall
(N=888)
Age, years, median (Q1, Q3)* 58 (51, 65) 57 (49, 64) 59 (52, 65) 58 (51, 65)
BMI, kg/m2, median (Q1, Q3)* 34 (31, 40) 35 (31, 39) 35 (31, 40) 35 (31, 40)
Female, % 55 56 57 56
Hispanic, % 16 21 26 21
White, % 87 90 90 89
Type 2 diabetes, % 67 70 68 68
Hypertension, % 81 76 80 79
Dyslipidemia, % 70 71 73 71
Thyroxine use, %† 15 12 15 14
Statin use, % 49 47 51 49
ALT, U/L, median (Q1, Q3)* 46 (31, 70) 48 (32, 67) 48 (34, 69) 48 (33, 68)
AST, U/L, median (Q1, Q3)* 36 (25, 48) 34 (26, 46) 36 (25, 52) 36 (26, 49)
Demographics and
comorbidities 		Placebo
(n=294) 		Rezdiffra 80 mg
(n=298) 		Rezdiffra 100 mg (n=296) Overall
(N=888)
Age, years, median (Q1, Q3)* 58 (51, 65) 57 (49, 64) 59 (52, 65) 58 (51, 65)
BMI, kg/m2, median (Q1, Q3)* 34 (31, 40) 35 (31, 39) 35 (31, 40) 35 (31, 40)
Female, % 55 56 57 56
Hispanic, % 16 21 26 21
White, % 87 90 90 89
Type 2 diabetes, % 67 70 68 68
Hypertension, % 81 76 80 79
Dyslipidemia, % 70 71 73 71
Thyroxine use, %† 15 12 15 14
Statin use, % 49 47 51 49
ALT, U/L, median (Q1, Q3)* 46 (31, 70) 48 (32, 67) 48 (34, 69) 48 (33, 68)
AST, U/L, median (Q1, Q3)* 36 (25, 48) 34 (26, 46) 36 (25, 52) 36 (26, 49)

Patients were allowed to be on stable doses of concomitant medications for diabetes (including 15% of patients on GLP‑1 therapy), dyslipidemia (including 49% of patients on statins), and hypertension.1,2

Assessment of baseline disease parameters Placebo
(n=294) 		Rezdiffra
80 mg
(n=298) 		Rezdiffra
100 mg
(n=296) 		Overall
(N=888)
NITs VCTE, kPa, median (Q1, Q3)* 12 (10, 15) 12 (10, 15) 12 (10, 16) 12 (10, 15)
CAP, dB/m, median (Q1, Q3)* 350 (321, 379) 348 (317, 375) 350 (324, 381) 349 (320, 378)
FIB-4, median (Q1, Q3)* 1.3 (1, 1.8) 1.3 (0.9, 1.7) 1.4 (1, 1.9) 1.3 (1, 1.8)
ELF, median (Q1, Q3)* 9.7 (9.2, 10.3) 9.7 (9.2, 10.3) 9.8 (9.3, 10.4) 9.7 (9.2, 10.4)
Liver Biopsy Fibrosis stage F2, % 38 37 36 37
Fibrosis stage F3, % 62 63 64 63
Assessment of baseline disease parameters Placebo
(n=294) 		Rezdiffra 80 mg
(n=298) 		Rezdiffra 100 mg (n=296) Overall
(N=888)
NITs VCTE, kPa, median (Q1, Q3)* 12 (10, 15) 12 (10, 15) 12 (10, 16) 12 (10, 15)
CAP, dB/m, median (Q1, Q3)* 350 (321, 379) 348 (317, 375) 350 (324, 381) 349 (320, 378)
FIB-4, median (Q1, Q3)* 1.3 (1, 1.8) 1.3 (0.9, 1.7) 1.4 (1, 1.9) 1.3 (1, 1.8)
ELF, median (Q1, Q3)* 9.7 (9.2, 10.3) 9.7 (9.2, 10.3) 9.8 (9.3, 10.4) 9.7 (9.2, 10.4)
Liver Biopsy Fibrosis stage F2, % 38 37 36 37
Fibrosis stage F3, % 62 63 64 63

Patients in the study had a NAFLD Activity Score (NAS) ≥4 at baseline.2

*This represents the middle 50% (Q1, Q3). 25% of the data fall below Q1 and 25% of the data lie above Q3.3

AASLD Practice Guidance: Patient Identification for Rezdiffra

The latest guidance from AASLD recommends Rezdiffra for appropriate patients with noncirrhotic MASH with moderate to advanced fibrosis.4,†

Rezdiffra recommended

Rezdiffra recommended

Imaging-based NILDA:

  • VCTE: LSM 8 kPa-15 kPa‡
  • MRE: LSM 3.1 kPa-4.4 kPa‡

Liver histology:

  • MASH with F2-F3§

Rezdiffra
may be used

Rezdiffra
may be used

Individualized decisions by a specialist experienced in liver fibrosis for:

  • LSM values outside the recommended ranges
  • Other NILDA data consistent with F2-F3||

Rezdiffra is
not recommended

Rezdiffra is
not recommended

  • Cirrhosis, including LSM via VCTE >20 kPa or MRE >5 kPa
  • Concomitant active liver disease
  • Excessive alcohol use (>20/30 g/d in women/men)
  • Active thyroid disease
There are no FDA-approved noninvasive tests to diagnose MASH with fibrosis stage F2-F3 or to monitor response to pharmacotherapy.
†Adapted from Figure 1 in the AASLD Practice Guidance: October 2024 Updates.
‡Modified from the AASLD NILDA guidelines.5
§Liver biopsy is not routinely recommended for staging of MASH.4
||Imaging-based NILDA is preferred, eg, shear wave elastography (applying local standards for F2-F3), versus enhanced liver fibrosis score (9.2-10.4). The latter range is based on the interquartile range from the MAESTRO trial data; no recommendations are available from the AASLD NILDA guidelines.1,6
Persons with active hyperthyroidism or untreated hypothyroidism (ie, TSH >10 mIU/L without symptoms, or TSH >7 mIU/L with symptoms) were excluded from the MAESTRO-NASH study.4

Rezdiffra delivered statistically significant results for both primary endpoints in MAESTRO-NASH2

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AASLD=American Association for the Study of Liver Diseases; ALT=alanine transaminase; AST=aspartate aminotransferase; BMI=body mass index; CAP=controlled attenuation parameter; dB/m=decibels per meter; ELF=enhanced liver fibrosis; FIB‑4=Fibrosis-4; GLP-1=glucagon-like peptide-1; kPa=kilopascal; LSM=liver stiffness measure; MASH=metabolic dysfunction-associated steatohepatitis, formerly known as NASH or nonalcoholic steatohepatitis; MRE=magnetic resonance elastography; NAFLD=nonalcoholic fatty liver disease; NILDA=noninvasive liver disease assessment; NIT=noninvasive test; Q=quartile; TSH=thyroid-stimulating hormone; U/L=units per liter; VCTE=vibration-controlled transient elastography.
References:
  1. Data on file. REF-00630. Madrigal Pharmaceuticals, Inc.; June 2024.
  2. Rezdiffra. Prescribing Information. Madrigal Pharmaceuticals, Inc.
  3. Thomas S. https://articles.outlier.org/what-are-quartiles-in-statistics. March 26, 2023.
  4. Chen VL et al. Hepatology. 2025;81(1):312-320.
  5. Sterling RK et al. Hepatology. Published online March 15, 2024.
  6. Sterling RK et al. Hepatology. 2024;81(1):321-357.