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New treatment option for Metabolic Dysfunction-Associated SteatoHepatitis (MASH)
Official title A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition
ClinicalTrials.gov ID: NCT05519475
What this study is testing
What is ALN-HSD?
ALN-HSD is an investigational medicine, being studied as a potential treatment for metabolic dysfunction-associated steatohepatitis (mash).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is researching an investigational drug, ALN-HSD called "study drug". This study is focused on participants who are known to have Metabolic dysfunction-Associated SteatoHepatitis (MASH).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Adult male or female ≥18 years (or country's legal age of adulthood)
- A diagnosis of MASH with Fibrosis (F) stage 2 or 3, according to the NASH-CRN
- NAS score ≥3, as defined in the protocol
- Meets genotype criteria for study enrollment, as defined in the protocol
- Has a protocol defined FibroScan®-AST (FAST) score at screening or within approximately 12 weeks of screening Key
You likely can't join if
- Evidence of other forms of known chronic liver disease, as defined in the protocol
- Known history of alcohol or other substance abuse within the last year or at any time during screening, as defined in the protocol
- History of Type 1 diabetes
- Bariatric surgery within approximately 5 years prior to or planned during the study period
- Prior exposure to any investigational drug targeting HSD17B13 or patatin-like phospholipase domain containing 3 (PNPLA3) (eg, ALN-HSD, ARO-HSD...
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Flagstaff, Arizona, United States
- Peoria, Arizona, United States
- Tucson, Arizona, United States
- Canoga Park, California, United States
- Chula Vista, California, United States
- Coronado, California, United States
- Fountain Valley, California, United States
- Gardena, California, United States
- Huntington Park, California, United States
- Lancaster, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Panorama City, California, United States
- Pasadena, California, United States
- Poway, California, United States
- Rialto, California, United States
- San Diego, California, United States
- Aurora, Colorado, United States
+ 38 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Flagstaff, Arizona, United States; Peoria, Arizona, United States; Tucson, Arizona, United States; Canoga Park, California, United States; Chula Vista, California, United States and 52 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.