NCT06215716 A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
| NCT ID | NCT06215716 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Akero Therapeutics, Inc |
| Condition | NASH With Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,650 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2033-02 |
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 1,650 participants in total. It began in 2023-12-01 with a primary completion date of 2033-02.
⚠ 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 non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.
Eligibility Criteria
Inclusion Criteria: * Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit. * Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes. * Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components: * Steatosis (scored 0 to 3), * Ballooning degeneration (scored 0 to 2), and * Lobular inflammation (scored 0 to 3). * Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS \<4 may be enrolled and are not required to meet 1 point in each of the components of NAS. Exclusion Criteria: * Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results. * Presence of cirrhosis on liver biopsy (fibrosis stage 4). * Type 1 or uncontrolled Type 2 diabetes. Other inclusion and exclusion criteria may apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06215716 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying NASH With Fibrosis. 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 NCT06215716 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 1,650 participants.
Is NCT06215716 currently recruiting?
Yes, NCT06215716 is actively recruiting participants. Contact the research team at AkeroSynchrony@akerotx.com for enrollment information.
Where is the NCT06215716 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 NCT06215716 clinical trial?
NCT06215716 is sponsored by Akero Therapeutics, Inc. The trial plans to enroll 1,650 participants.