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RNAi Therapeutics

ALN-HSD for NASH with Fibrosis (NASHGEN-2 Trial)

Phase 2
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 84
Awards & highlights

NASHGEN-2 Trial Summary

This trial will look at how a new drug affects liver fibrosis, steatohepatitis, and other biomarkers of liver health.

Who is the study for?
This trial is for adults with a condition called NASH, where fat buildup leads to liver inflammation and scarring. Participants must have a certain level of liver damage (stage 2 or 3 fibrosis) and meet specific genetic criteria.Check my eligibility
What is being tested?
The study tests ALN-HSD, an investigational drug, against a placebo to see if it can reduce liver scarring in NASH patients. It also examines how the body processes the drug and its effects on liver function and inflammation.See study design
What are the potential side effects?
Potential side effects from ALN-HSD are not detailed here but typically could include reactions at the injection site, gastrointestinal symptoms, fatigue, headache, and possible abnormal blood tests reflecting liver or kidney function.

NASHGEN-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 84 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in qFibrosis
Secondary outcome measures
Change in Fibrosis-4 (FIB-4)
Change in N-terminal type III collagen propeptide (PRO-C3)
Change in NIS4, a non-invasive fibrosis biomarker of NASH
+9 more

NASHGEN-2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ALN-HSDExperimental Treatment1 Intervention
Randomized 1:1
Group II: PlaceboPlacebo Group1 Intervention
Randomized 1:1

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
620 Previous Clinical Trials
380,345 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
5,511 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
262 Previous Clinical Trials
251,154 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
5,511 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

ALN-HSD (RNAi Therapeutics) Clinical Trial Eligibility Overview. Trial Name: NCT05519475 — Phase 2
ALN-HSD (RNAi Therapeutics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05519475 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age criteria for this clinical trial include people over 55 years of age?

"This clinical trial accepts patients from the age of 18 to 75 years old."

Answered by AI

Is recruitment for this experiment still ongoing?

"The details on clinicaltrials.gov verifiy that this medical trial is actively recruiting patients, with the original posting date being February 9th 2023 and last edit occurring on the 15th day of that same month."

Answered by AI

To what extent can Study 2 ALN-HSD Low Dose be considered hazardous to test subjects?

"Our team at Power assigned Study 2 ALN-HSD Low Dose a rating of 2, given that there is evidence to suggest its safety but none yet affirming its efficacy."

Answered by AI

How many participants has this trial recruited thus far?

"Indeed, details on clinicaltrials.gov verify that this medical trial is actively looking for participants; it was first posted in the second week of February 2021 and has since been updated. 300 people are sought to be recruited at a single site."

Answered by AI

Who meets the eligibility criteria to participate in this clinical research?

"This clinical trial requires 300 individuals with non-alcoholic fatty liver disease (NAFLD) aged between 18 and 75 to take part. Furthermore, applicants must have a NASH diagnosis of fibrosis stage 2 or 3, an appropriate NAS score according to the NASH CRN histological scoring system, as well as meet genotype criteria for enrolment in either Study 1 or Study 2."

Answered by AI

Who else is applying?

What site did they apply to?
National
Velocity Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Non-Alcoholic Steatohepatitis (NASH) in Adult Participants at Increased Genetic Risk for This Condition
2023. "A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Non-Alcoholic Steatohepatitis (NASH) in Adult Participants at Increased Genetic Risk for This Condition". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05519475.
All > Fatty Liver Disease > Nash
~80 spots leftby Sep 2027
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