Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05039450 · ClinicalTrials.gov registry record · Phase 2
A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)
A Phase 2 study of NASH - Nonalcoholic Steatohepatitis, sponsored by Akero Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 182
- Enrollment target
- 20
- Study locations
NCT05039450: Active Phase 2 study of NASH - Nonalcoholic Steatohepatitis, sponsored by Akero Therapeutics.
NCT05039450 is a Phase 2 study of NASH - Nonalcoholic Steatohepatitis that is active but no longer recruiting, run by Akero Therapeutics. The registered enrollment target is 182 participants, below the 255-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05039450, a Phase 2 study of NASH - Nonalcoholic Steatohepatitis, is active but no longer recruiting, sponsored by Akero Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 182 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.
Primary Outcome
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 36. No worsening of steatohepatitis was defined as no increase in score for any of the 3 components of NAS. The evaluation of the NAS endpoint was calculated using the following 3 categorical features: steatosis \[0-3\], lobular inflammation \[0-3\], and hepatocellular ballooning \[0-2\]. NAS was derived as the unweighted sum of steatosis, lobular in
Conditions Studied
Interventions
- DRUG Placebo
- DRUG EFX
Study Locations (20)
Florida
- Akero Clinical Study Site - Clearwater
- Akero Clinical Study Site - Fort Myers
- Akero Clinical Study Site - Fort Myers
- Akero Clinical Study Site - Hialeah Gardens
- Akero Clinical Study Site - Lakewood Rch
- Akero Clinical Study Site - Miami Lakes
- Akero Clinical Study Site - Ocala
- Akero Clinical Study Site - Sarasota
Arizona
- Akero Clinical Study Site - Chandler
- Akero Clinical Study Site - Glendale
- Akero Clinical Study Site - Tucson
- Akero Clinical Study Site - Tucson
California
- Akero Clinical Study Site - Fresno
- Akero Clinical Study Site - Long Beach
- Akero Clinical Study Site - Los Angeles
- Akero Clinical Study Site - Pasadena
Arkansas
- Akero Clinical Study Site - North Little Rock
Colorado
- Akero Clinical Study Site - Englewood
Indiana
- Akero Clinical Study Site - South Bend
Kansas
- Akero Clinical Study Site - Topeka
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2021-07-30 |
| Est. Completion | 2025-05 |
| Phase | Phase 2 |
What the registry record for NCT05039450 still lists
NCT05039450 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, below the 255-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (29% lower).
The record links to 1 condition, with NASH - Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05039450 names 20 study sites across 7 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT05039450 about?
NCT05039450 is a clinical study titled "A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)". This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.
What is the current status of trial NCT05039450?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 182 participants. The study started on 2021-07-30. Estimated completion is 2025-05.
What conditions does trial NCT05039450 study?
This clinical trial studies the following conditions: NASH - Nonalcoholic Steatohepatitis.
What interventions are being tested in trial NCT05039450?
The interventions under investigation include: Placebo (DRUG), EFX (DRUG).
Who is sponsoring clinical trial NCT05039450?
This trial is sponsored by Akero Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05039450 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for NASH - Nonalcoholic Steatohepatitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05039450's enrollment target sits among peer trials
182 10th of 28 higher than 19 of 28 other NASH - Nonalcoholic Steatohepatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NASH - Nonalcoholic Steatohepatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects
ACTIVE NOT RECRUITING · Phase 2
-
Statins for the Treatment of NASH
ACTIVE NOT RECRUITING · Phase 2
-
Tocotrienol Against the Progression of End Stage Liver Disease
ACTIVE NOT RECRUITING · Phase 2
-
Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers
COMPLETED · Phase 2
-
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
COMPLETED · Phase 2
-
A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03897998 · 182 participants · Phase 2
Neural Correlates of Hypoalgesia Driven by Observation
- NCT04300556 · 182 participants · Phase 1
A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types
- NCT04323735 · 182 participants · Phase 2
Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters
- NCT05606731 · 182 participants · NA
Family Intervention to Prevent Childhood Obesity
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI