NASH Clinical Trials NCT02913105 and NCT02855164
Novartis Pharmaceuticals is sponsoring two clinical research trials for adults 18 years or older with Non‑Alcoholic Steatohepatitis (NASH). NASH is a common but often ‘silent’ condition that results in liver inflammation and damage due to a build up of fat in the liver. Although similar to alcoholic liver disease, it is not caused by drinking too much alcohol.
Most people with NASH feel well and are not aware that they have a liver problem. However, NASH can be severe and lead to cirrhosis, a condition causing permanent liver damage and scarring. For patients with NASH, the liver is no longer working properly. To learn more about NASH, click here.
The main purpose of each study is to investigate whether the study drug used is safe and effective in treating patients with NASH.
If you are eligible and agree to participate in one of the studies, you will be treated with either LMB763 or LJN452 (the study drugs) or a placebo (a dummy drug with no active medicine, like a sugar pill) over a 12-week period.
To see if you may be eligible, click here for a pre-screener / questionnaire.
People who participate in either trial must meet the following requirements:
- Man or woman 18 years of age or older
- Have been diagnosed by their doctor with either:
- NASH (proven with a biopsy), OR
- Obesity AND Type 2 Diabetes Mellitus
- Have mildly elevated liver enzymes but have not been diagnosed with cirrhosis or severe liver impairment
- Are not pregnant or nursing
- Are not taking obeticholic acid (OCA)
- Do not have a history of drug or alcohol abuse within 12 months
- Have not participated in other studies and received a trial medication in the past 30 days.
Patients who are eligible and decide to enroll in either trial:
- Will take study medication (capsules) once daily for 12 weeks
- Will attend study visits weekly for their first two weeks, and then every other week until week 8, and then monthly until the end of the study
- Will not be charged to participate
- Will receive compensation for time and travel costs
- May withdraw from the trial at any time, for any reason.
To learn more about NASH, a liver condition, click here.
Additional study locations may be listed as they open in the future. We encourage you to share this information via the links at the top of the page.