Akero 105 (Metabolic Dysfunction-Associated Steatohepatitis)

Purpose of this Study

We are doing this study to find out if an experimental drug called efruxifermin (EFX) is a safe and effective option for people who have nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH) and liver fibrosis (scarring of the liver tissue).

Who Can Participate?

Eligibility

Adults ages 18-80 who:
  • Are diagnosed with MASH/NASH
  • Have a diagnosis that is proven by biopsy
  • Have a history of Type 2 Diabetes
For more information, contact the study team at adele.gaskin@duke.edu.

Age Range

18-80

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will get a random assignment (by chance) to 1 of 3 groups. Depending on your assignment, you will:
  • Get a 28mg dose of EFX; OR
  • Get a 50mg dose of EFX; OR
  • Get a placebo (inactive substance that has no drug in it)
You will take EFX or placebo for up to 96 weeks. Participation in the study will last for about 112 weeks. You will visit our clinic 24 times during the study, and the following procedures will be done over the course of the study: blood draws, liver biopsies, DXA scans, ultrasounds, and surveys.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF EFRUXIFERMIN IN SUBJECTS WITH NON-CIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH)/METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS (MASH) AND FIBROSIS

Principal Investigator

Amreen
Dinani

Protocol Number

PRO00115651

NCT ID

NCT06215716

Phase

III

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov