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RecruitingPhase 3

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Akero Therapeutics, Inc · NCT06215716

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
1650
US sites recruiting
159
Study start
December 1, 2023
Record last updated
October 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Efruxifermin; Placebo

Conditions: NASH With Fibrosis; MASH With Fibrosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Akero Clinical Study Site

    Birmingham, AL 35209

    Site contact: Akero Site 0129

  • Akero Clinical Study Site

    Dothan, AL 36301

    Site contact: Akero Site 0233

  • Akero Clinical Study Site

    Chandler, AZ 85224

    Site contact: Akero Site 9106

  • Akero Clinical Study Site

    Peoria, AZ 85381

    Site contact: Akero Site 9104

  • Akero Clinical Study Site

    Tucson, AZ 85712

    Site contact: Akero Site 9210

  • Akero Clinical Study Site

    Tucson, AZ 85712

    Site contact: Akero Site 9144

  • Akero Clinical Study Site

    Tucson, AZ 85713

    Site contact: Akero Site 0234

  • Akero Clinical Study Site

    Tucson, AZ 85715

    Site contact: Akero Site 0209

  • Akero Clinical Study Site

    Little Rock, AR 72205

    Site contact: Akero Site 0106

  • Akero Clinical Study Site

    North Little Rock, AR 72117

    Site contact: Akero Site 9214

  • Akero Clinical Study Site

    Coronado, CA 92118

    Site contact: Akero Site 0132

  • Akero Clinical Study Site

    Escondido, CA 92025

    Site contact: Akero Site 0266

  • Akero Clinical Study Site

    Folsom, CA 95630

    Site contact: Akero Site 0263

  • Akero Clinical Study Site

    Lancaster, CA 93534

    Site contact: Akero Site 0285

  • Akero Clinical Study Site

    Long Beach, CA 90815

    Site contact: Akero Site 0188

  • Akero Clinical Study Site

    Los Angeles, CA 90048

    Site contact: Akero Site 0236

  • Akero Clinical Study Site

    Los Angeles, CA 90057

    Site contact: Akero Site 0168

  • Akero Clinical Study Site

    Newport Beach, CA 92663

    Site contact: Akero Site 0206

  • Akero Clinical Study Site

    Orange, CA 92868

    Site contact: Akero Site 0261

  • Akero Clinical Study Site

    Pasadena, CA 91105

    Site contact: Akero Site 9250

  • Akero Clinical Study Site

    Redwood City, CA 94063

    Site contact: Akero Site 0191

  • Akero Clinical Study Site

    Sacramento, CA 95817

    Site contact: Akero Site 0274

  • Akero Clinical Study Site

    San Diego, CA 92161

    Site contact: Akero Site 0199

  • Akero Clinical Study Site

    San Francisco, CA 94115

    Site contact: Akero Site 0147

  • Akero Clinical Study Site

    San Francisco, CA 94117

    Site contact: Akero Site 0269

  • Akero Clinical Study Site

    Santa Maria, CA 93458

    Site contact: Akero Site 0205

  • Akero Clinical Study Site

    Aurora, CO 80045

    Site contact: Akero Site 0217

  • Akero Clinical Study Site

    Colorado Springs, CO 80907

    Site contact: Akero Site 0260

  • Akero Clinical Study Site

    Englewood, CO 80113

    Site contact: Akero Site 9243

  • Akero Clinical Study Site

    New Haven, CT 06520

    Site contact: Akero Site 0213

  • Akero Clinical Study Site

    Washington D.C., DC 20422

    Site contact: Akero Site 0262

  • Akero Clinical Study Site

    Bradenton, FL 34208

    Site contact: Akero Site 0153

  • Akero Clinical Study Site

    Brandon, FL 33511

    Site contact: Akero Site 0222

  • Akero Clinical Study Site

    Doral, FL 33126

    Site contact: Akero Site 0267

  • Akero Clinical Study Site

    Fort Myers, FL 33912

    Site contact: Akero Site 9134

  • Akero Clinical Study Site

    Gainesville, FL 32610

    Site contact: Akero Site 0114

  • Akero Clinical Study Site

    Hialeah Gardens, FL 33016

    Site contact: Akero Site 9242

  • Akero Clinical Study Site

    Inverness, FL 34452

    Site contact: Akero Site 9135

  • Akero Clinical Study Site

    Jacksonville, FL 32256

    Site contact: Akero Site 0118

  • Akero Clinical Study Site

    Lakewood Rch, FL 34211

    Site contact: Akero Site 9203

  • Akero Clinical Study Site

    Largo, FL 33777

    Site contact: Akero Site 9248

  • Akero Clinical Study Site

    Lehigh Acres, FL 33936

    Site contact: Akero Site 0271

  • Akero Clinical Study Site

    Margate, FL 33063

    Site contact: Akero Site 0248

  • Akero Clinical Study Site

    Miami, FL 33136

    Site contact: Akero Site 0137

  • Akero Clinical Study Site

    Miami, FL 33175

    Site contact: Akero Site 0252

  • Akero Clinical Study Site

    Miami Gardens, FL 33014

    Site contact: Akero Site 0243

  • Akero Clinical Study Site

    Miami Lakes, FL 33016

    Site contact: Akero Site 9138

  • Akero Clinical Study Site

    Naples, FL 34102

    Site contact: Akero Site 0138

  • Akero Clinical Study Site

    Ocala, FL 34471

    Site contact: Akero Site 9127

  • Akero Clinical Study Site

    Orlando, FL 32807

    Site contact: Akero Site 0250

  • Akero Clinical Study Site

    Pembroke Pines, FL 33027

    Site contact: Akero Site 0239

  • Akero Clinical Study Site

    Port Orange, FL 32127

    Site contact: Akero Site 9105

  • Akero Clinical Study Site

    Riverview, FL 33578

    Site contact: Akero Site 0295

  • Akero Clinical Study Site

    Sarasota, FL 34240

    Site contact: Akero Site 9218

  • Akero Clinical Study Site

    Temple Terrace, FL 33617

    Site contact: Akero Site 0242

  • Akero Clinical Study Site

    Weston, FL 33331

    Site contact: Akero Site 0270

  • Akero Clinical Study Site

    Winter Park, FL 32789

    Site contact: Akero Site 0157

  • Akero Clinical Study Site

    Winter Park, FL 32792

    Site contact: Akero Site 0187

  • Akero Clinical Study Site

    Zephyrhills, FL 33542

    Site contact: Akero Site 0235

  • Akero Clinical Study Site

    Atlanta, GA 30309

    Site contact: Akero Site 0230

+ 99 more on the official record.

Study contacts (from the official record)

  • Akero Study Director · 650-487-6488 · AkeroSynchrony@akerotx.com
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