Caring for patients with NASH?

Consider the NASHGEN-2 clinical study

Most people with NASH feel well and are not aware that they have a liver problem, but over time, NASH can progress to liver failure. NASHGEN-2 is currently underway to investigate potential treatments with genetic risk factors for NASH. Consider the NASHGEN-2 study as an opportunity for your patients with NASH to access emerging treatments.

NASHGEN-2 is a phase 2 clinical study for adult patients with NASH that is looking at the safety and effectiveness of an investigational treatment (ALN-HSD) in those who have NASH and certain genetic risk factors. This study is evaluating the effect of the investigational treatment on liver fibrosis.

Over the course of the study, the investigational treatment or placebo will be administered as a subcutaneous injection every 4 weeks for a total of 13 doses. The study treatment (ALN-HSD) is a synthetic small interfering RNA (siRNA) targeting HSD17B13 mRNA, conjugated to an N-acetylgalactosamine (GalNAc) containing ligand to facilitate specific delivery to the liver (hepatocytes). By reducing expression of functional HSD17B13 in the liver, it is hypothesized that the investigational treatment (ALN-HSD) will mimic endogenous loss of function variants of HSD17B13, leading to reduced inflammation, hepatic injury, and fibrosis in patients with NASH.

Patients are expected to participate in this study for approximately 100 weeks. During the study, participants will have 21 study visits, which include 16 visits in the treatment period (comprised of 13 dosing visits and 3 safety visits). After the treatment period, participants will have a safety follow-up period consisting of 2 follow-up visits.

Qualified participants may be reimbursed for study-related travel and accommodation costs.

How can you help?

NASHGEN-2 is enrolling approximately 120 people with NASH worldwide. The success of NASHGEN-2 depends on physicians to refer potential study participants.

Your patients may be considered for study screening if they are between the ages of 18 and 75 AND they meet all of the criteria for Option 1 AND/OR Option 2:**

Option 1

Have documented evidence of NAFLD within the past 12 months based on at least 1 of the following:
– Liver biopsy with grade 1 steatosis (S1)   or higher
– Liver fat ≥ 5% by MRI-PDFF
– Fibroscan controlled attenuation
parameter ≥ 280 dB/m
– CT mean liver attenuation ≤ 45 Hounsfield units
Have an AST ≥ 30 U/L within the past 12 months
Have at least one of the following: 
– Diagnosis of type 2 diabetes 
– BMI ≥ 30kg/m² + ≥ 2 metabolic syndrome criteria*
– Age ≥ 50 years + ≥ 3 metabolic syndrome criteria*

AND/OR

Option 2

Age ≥ 50 years
BMI ≥ 35kg/m²
Diagnosis of type 2 diabetes

*Metabolic Syndrome Criteria:

For those of non-Asian descent, waist circumference ≥ 102 cm males, ≥ 88 cm females, waist; for those of Asian descent, waist circumference ≥ 90 cm males, ≥ 80 cm females
Blood pressure ≥ 130/85 mm Hg or use of medications to control blood pressure
Fasting triglycerides ≥ 150 mg/dL or use of triglyceride lowering medications
Fasting HDL-c ≤ 40 mg /dL males, ≤ 50 mg/dL females or use of lipid lowering medications
Fasting glucose ≥ 100 mg/dL or use of medications for type 2 diabetes

**Investigators should refer to study documents for most updated guidance criteria.

Please note: Other protocol-defined inclusion/exclusion criteria apply.  

The study team will check your patient’s full medical history. Qualifying patients may undergo genetic testing and liver biopsy to determine if they meet eligibility criteria.

If you have potentially eligible and interested patients, empower them with options and discuss the NASHGEN-2 clinical study. You may also contact the nearest study site to refer them.

Find a study site near you!

Your patient’s health and safety are our top priorities. We hope you value the impact of this research and will consider referring potential candidates. With your support, we aim to advance research for people living with NASH.