It is essential for clinicians to remain informed about emerging clinical trial opportunities and resulting data that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life.

Today, we are taking a look at active, Phase 3 clinical trials focusing on or related to metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The trials outlined below all have anticipated primary completion dates within the next two years.

Quick View Table of MASLD and NASH Clinical Trials

Study TitleEstimated EnrollmentRecruiting?Start DateEstimated Primary Completion
A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH (ZENITH-2)1250YesDecember 2025March 2028
A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH (ZENITH-1)1200YesOctober 2025March 2028
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH762YesMay 2024June 2028
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 ) (NATiV3)1000NoAugust 2021September 2027
A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)810NoJuly 2021March 2027

Featured Phase 3 Clinical Trials

A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH (ZENITH-2)

  • Sponsor: GlaxoSmithKline
  • Goal: This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.
  • Interventions: Efimosfermin alfa, placebo
  • Primary Outcome Measures: Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity; Number of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity; Number of participants with Grade 3 and Grade 4 laboratory abnormalities. 
  • Time Frames: At week 52; At week 52; At week 52.
  • Study Details
  • Source

A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH (ZENITH-1)

  • Sponsor: GlaxoSmithKline
  • Goal: The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.
  • Interventions: Efimosfermin alfa, placebo
  • Primary Outcome Measures: Proportion of participants experiencing improvement in fibrosis by >=1 stage and no worsening of steatohepatitis at week 52; Proportion of participants experiencing resolution of steatohepatitis reading and no worsening of MASH CRN fibrosis score at week 52; Time from randomization to an adjudicated composite liver-related clinical outcome.
  • Time Frames: At week 52; At week 52; From randomization (day 1) to 48 months.
  • Study Details
  • Source

A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

  • Sponsor: 89bio
  • Goal: The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH [previously known as nonalcoholic steatohepatitis, NASH]).
  • Interventions: Pegozafermin, placebo
  • Primary Outcome Measures: Proportion of participants achieving fibrosis regression; Time to first occurrence of disease progression as measured by composite of protocol-specified clinical events.
  • Time Frames: Baseline through month 24; Baseline up to five years.
  • Study Details
  • Source

A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)

  • Sponsor: Madrigal Pharmaceuticals
  • Goal: A 52-week, multi-center, open-label, active treatment extension study to evaluate safety and tolerability of once daily, oral administration of resmetirom (MGL-3196).
  • Intervention: Resmetirom
  • Primary Outcome Measure: The effect of once daily, oral administration of resmetirom on the incidence of adverse events.
  • Time Frame: 52 weeks. 
  • Study Details
  • Source

A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 ) (NATiV3)

  • Sponsor: Inventiva Pharma
  • Goal: This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3.
  • Interventions: IVA337, placebo
  • Primary Outcome Measures: Resolution of NASH and improvement of fibrosis; Safety analyses.
  • Time Frames: Part A: Date of randomization until the date of biopsy at week 72; 48 weeks after completion of DBPC period.
  • Study Details
  • Source

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