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Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis

Title Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE 4)
Therapeutic Area Non-Alcoholic steatohepatitis, Cirrhosis
Principal Investigator Raza Malik
Min Age 18 Years
Max Age 75 Years
Gender All
Contact Christina Picornell
617-636-0653
cpicornell@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04210245

Overview

You are being invited to consider participation in a clinical research study for patients with cirrhosis caused by nonalcoholic steatohepatitis (NASH) This study involves research and is conducted to determine the safety and efficacy of a new investigational drug called aldafermin (previously known as NGM282

Study Details

Inclusion Criteria

  • Diagnosis of NASH Cirrhosis
  • Willing/able to have a liver biopsy performed
  • Willing/able to have an MRI performed

Exclusion Criteria

  • No other causes of cirrhosis besides NASH (Alcohol abuse, HBV, HCV, etc.)
  • History of hepatic decompensation (variceal bleeding, ascites, or hepatic encephalopathy)
  • Prior or pending liver transplantation

Study Requirements

This study consists of 3 periods: The screening period will last about 8 weeks. During the screening period, you will be asked questions and will have certain tests performed such as a liver ultrasound, a ECG (measures the natural electrical activity in your heart), a Fibroscan (measures scarring/fat in the liver), an MRI, an EGD (A scan to look at your esophagus, stomach, and small intestine), and a liver biopsy as well as have blood and urine samples collected to see if you qualify for this study.

The treatment period will last 48 weeks. You will be randomized in one of the following four treatment groups. This means that you have a 3 in 4 chance of receiving aldafermin and a 1 in 4 chance of receiving a placebo. You will also be randomized to take rosuvastatin or placebo. A placebo looks like aldafermin/rouvastatin but does not contain the active ingredient. During this time, you will have study tests done and you will take study drug as an injection once daily and rouvastatin/placebo will be in pill form.

Throughout the course of the study you will have 6 ECGs, 3 Ultrasounds, 3 Fibroscans, 1 MRI, 1 EGD, 2 Liver Biopsies performed. The overall estimated amount of blood that will be taken from you over the duration of the study is about 3 cups (about 696 mL).

A 6-10 week follow-up period will occur after the end of the treatment period. During this period, you will not take the aldafermin study medication. However, you may be asked to take rosuvastatin to further manage your cholesterol levels and will have certain tests performed to monitor your health, including your cholesterol levels.