A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

NCT06528314
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
2,150
clinicaltrials.gov
Lead sponsor
Akero Therapeutics, Inc
clinicaltrials.gov
Start date
2024-09-04
clinicaltrials.gov
Number of sites
329
clinicaltrials.gov

Summary
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.
clinicaltrials.gov
Short title
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
clinicaltrials.gov
Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2030-03-01
clinicaltrials.gov
First posted
2024-07-30
clinicaltrials.gov
Registry last updated
2026-08-19
clinicaltrials.gov
Primary completion date
2030-02-01
clinicaltrials.gov
Start date
2024-09-04
clinicaltrials.gov

Participants
2,150
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
2,150
clinicaltrials.gov
Protocol amendments
3
clinicaltrials.gov
Number of sites
329
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Akero Therapeutics, Inc
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06528314
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06528314
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc.

    Timeframe: 5 years

    Measured by composite of protocol-specified clinical events

  2. Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis

    Timeframe: 96 Weeks

    Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)

  1. Change from baseline of non-invasive markers of liver fibrosis

    Timeframe: 96 Weeks, 5 Years

    ELF (scale of 6.7 to 11.3 with higher scores indicative of increased fibrosis)

  2. Change from baseline of non-invasive markers of liver fibrosis

    Timeframe: 96 Weeks, 5 Years

    Pro-C3 (ug/L)

  3. Change from baseline of non-invasive markers of liver fibrosis

    Timeframe: 96 Weeks, 5 Years

    Liver stiffness assessed by transient elastography (FibroScan®) (kPa)

  4. Change from baseline of markers of liver injury

    Timeframe: 96 Weeks, 5 Years

    ALT (U/L) and AST (U/L)

  5. Change from baseline of lipoproteins

    Timeframe: 96 Weeks, 5 Years

    Total cholesterol (mg/dL), Triglycerides (mg/dL), HDL-C (mg/dL), Non-HDL-C (mg/dL), and LDL-C (mg/dL)

  6. Change from baseline of markers of insulin sensitivity and glycemic control

    Timeframe: 96 Weeks, 5 Years

    HbA1c (%)

  7. Change from baseline of markers of insulin sensitivity and glycemic control

    Timeframe: 96 Weeks, 5 Years

    C-Peptide (ng/mL)

  8. Change from baseline of markers of insulin sensitivity and glycemic control

    Timeframe: 96 Weeks, 5 Years

    Adiponectin (mg/L)

  9. Change from baseline of markers of insulin sensitivity and glycemic control

    Timeframe: 96 Weeks, 5 Years

    Insulin (mIU/L)

  10. Change from baseline of markers of insulin sensitivity and glycemic control

    Timeframe: 96 Weeks, 5 Years

    HOMA-IR (≥ 2.5 indicates insulin resistance)

  11. Change from baseline of body weight (kg)

    Timeframe: 96 Weeks, 5 Years

  12. Safety and tolerability of EFX through the reporting of extent of exposure (weeks)

    Timeframe: From first dose through end of study (up to 5 Years)

  13. Safety and tolerability of EFX through the reporting of adverse events (frequency of events)

    Timeframe: From first dose through end of study (up to 5 Years)

    Proportion of subjects reporting adverse events

  14. Safety and tolerability of EFX through the reporting of adverse events (severity of events)

    Timeframe: From first dose through end of study (up to 5 Years)

    Proportion of subjects reporting adverse events

  15. Number of participants with abnormal laboratory tests results, abnormal ECGs, abnormal ultrasounds, abnormal vital sign assessments

    Timeframe: From first dose through end of study (up to 5 years)

  16. Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis

    Timeframe: 5 Years

    Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)

  17. Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis

    Timeframe: 96 Weeks

    Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)

  18. Cohort 1 only: Proportion of subjects with Resolution of NASH/MASH

    Timeframe: 96 Weeks

    Based on NAS (scored by 0-1 for steatosis, 0-3 for inflammation, and 0-2 for ballooning)

  19. Cohort 1 only: Proportion of subjects with Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis

    Timeframe: 96 Weeks

    Based on NAS (scored by 0-1 for steatosis, 0-3 for inflammation, and 0-2 for ballooning) and NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

  • Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH and NAS score of >=3 (at least 1 in each category) or evidence of steatosis and 2 current features of metabolic comorbidities
  • Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH

  • Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results
  • Type 1 diabetes or unstable Type 2 diabetes
  • Any current or prior history of decompensated liver disease

Other inclusion and exclusion criteria may apply.

Sources for eligibility
clinicaltrials.gov

  • Akero Clinical Study SiteBirmingham, United StatesRecruiting
  • Akero Clinical Study SiteDothan, United StatesRecruiting
  • Akero Clinical Study SiteChandler, United StatesRecruiting
  • Akero Clinical Study SiteFlagstaff, United StatesCompleted
  • Akero Clinical Study SitePeoria, United StatesRecruiting
  • Akero Clinical Study SiteScottsdale, United StatesRecruiting
  • Akero Clinical Study SiteTucson, United StatesRecruiting
  • Akero Clinical Study SiteTucson, United StatesRecruiting
  • Akero Clinical Study SiteTucson, United StatesRecruiting
  • Akero Clinical Study SiteTucson, United StatesRecruiting
  • Akero Clinical Study SiteConway, United StatesCompleted
  • Akero Clinical Study SiteJonesboro, United StatesCompleted
  • Akero Clinical Study SiteLittle Rock, United StatesRecruiting
  • Akero Clinical Study SiteNorth Little Rock, United StatesRecruiting
  • Akero Clinical Study SiteCoronado, United StatesRecruiting
  • Akero Clinical Study SiteEscondido, United StatesRecruiting
  • Akero Clinical Study SiteFolsom, United StatesRecruiting
  • Akero Clinical Study SiteFountain Valley, United StatesRecruiting
  • Akero Clinical Study SiteLancaster, United StatesRecruiting
  • Akero Clinical Study SiteLong Beach, United StatesRecruiting
  • Akero Clinical Study SiteLos Angeles, United StatesRecruiting
  • Akero Clinical Study SiteNewport Beach, United StatesRecruiting
  • Akero Clinical Study SiteOrange, United StatesRecruiting
  • Akero Clinical Study SitePasadena, United StatesRecruiting
  • Akero Clinical Study SiteRedwood City, United StatesRecruiting

And 304 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)