NCT06528314 A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
| NCT ID | NCT06528314 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Akero Therapeutics, Inc |
| Condition | NASH - Nonalcoholic Steatohepatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,150 participants |
| Start Date | 2024-09-04 |
| Primary Completion | 2030-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 2,150 participants in total. It began in 2024-09-04 with a primary completion date of 2030-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06528314 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying NASH - Nonalcoholic Steatohepatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06528314 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 2,150 participants.
Is NCT06528314 currently recruiting?
Yes, NCT06528314 is actively recruiting participants. Contact the research team at AkeroSynchrony@akerotx.com for enrollment information.
Where is the NCT06528314 trial being conducted?
This trial is being conducted at Birmingham, United States, Dothan, United States, Chandler, United States, Flagstaff, United States and 11 additional locations.
Who is sponsoring the NCT06528314 clinical trial?
NCT06528314 is sponsored by Akero Therapeutics, Inc. The trial plans to enroll 2,150 participants.