Have you or a loved one been diagnosed with NASH?
Akero Therapeutics is studying an investigational therapy (AKR-001) that has the potential to target NASH in a balanced way by addressing the underlying metabolic drivers of the disease along with reducing liver inflammation and fibrosis.
About The BALANCED Study
The BALANCED study is for people with non-alcoholic steatohepatitis (NASH). An estimated 17 million Americans have NASH, and the U.S. NASH patient population is expected to grow over 50% to 27 million by 2030.
NASH is the most severe form of non-alcoholic fatty liver disease (NAFLD). It happens when fat builds up in the liver, causing inflammation and scarring. Over time, as the scarring gets worse, it is harder for the liver to function.
The purpose of the BALANCED study is to determine the safety and effectiveness of different doses of a new investigational study drug on reducing the amount of fat in the liver.
The BALANCED Study Process
- Participants will sign an informed consent form and will go through a screening process to confirm eligibility, which will include a physical exam, heart test, blood test and liver assessments.
- If eligible, you will be randomly assigned to receive 1 of 3 doses of the study drug or placebo for 16 weeks.
- You will visit the clinic once a week for an injection of the study drug or placebo.
- Four weeks after the last dose, you will visit the clinic for a follow-up appointment and will receive a final liver biopsy if you respond well.
Screening: 6 weeks
Study Treatment: 16 weeks
Safety Follow-Up: 4 weeks
Repeat Liver Biopsy: 4 weeks
(for eligible participants)
Key Eligibility Criteria
18 to 80 years of age
(biopsy can be performed as part of study screening process)
No Type 1 or insulin-dependent Type 2 diabetes, cirrhosis or poorly controlled hypertension
No prior liver transplant
About the Treatment (AKR-001)
The study drug (AKR-001) is an investigational drug designed to target NASH and improve fat levels in the liver. AKR-001 has the potential to address the underlying drivers of NASH to reduce liver fat while also directly reducing inflammation and fibrosis of the liver. AKR-001 is considered an “investigational” drug product because it has not been approved by regulatory authorities like the U.S. Food and Drug Administration (FDA) for improving NASH. It can only be used for research purposes.
The BALANCED study is taking place in clinical trial sites across the United States (refer to map for the trial site closest to you). If you’re interested in learning more about the BALANCED study or would like to see if you qualify, please contact the following: