Gene silencing treatment for chronic liver disease in genetically at-risk adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the investigational drug ALN-HSD for treating metabolic dysfunction-associated steatohepatitis (MASH) in adults with increased genetic risk. The study aims to evaluate the drug's effectiveness in reducing liver scarring and inflammation associated with MASH. Participants will be monitored for liver function improvements, potential side effects, and the pharmacokinetics of the drug. The trial includes a placebo group for comparison.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Adult male or female ≥18 years (or country's legal age of adulthood)
2. A diagnosis of MASH with Fibrosis (F) stage 2 or 3, according to the NASH-CRN
3. NAS score ≥3, as defined in the protocol
4. Meets genotype criteria for study enrollment, as defined in the protocol
5. Has a protocol defined FibroScan®-AST (FAST) score at screening or within approximately 12 weeks of screening

Key Exclusion Criteria:

1. Evidence of other forms of known chronic liver disease, as defined in the protocol
2. Known history of alcohol or other substance abuse within the last year or at any time during screening, as defined in the protocol
3. History of Type 1 diabetes
4. Bariatric surgery within approximately 5 years prior to or planned during the study period
5. Prior exposure to any investigational drug targeting HSD17B13 or patatin-like phospholipase domain containing 3 (PNPLA3) (eg, ALN-HSD, ARO-HSD, ALN-PNP, AZD2693)

Note: Other protocol-defined Inclusion/Exclusion Criteria apply

Where it's running

• The Institute for Liver Health II LLC DBA Arizona Liver Health - Peoria
  Peoria, Arizona, United States Recruiting
• Adobe Clinical Research
  Tucson, Arizona, United States Recruiting
• Arizona Liver Health - Tucson
  Tucson, Arizona, United States Recruiting
• The Institute for Liver Health II LLC dba Arizona Liver Health
  Tucson, Arizona, United States Recruiting
• Del Sol Research Management, LLC
  Tucson, Arizona, United States Recruiting
• Southern California Research Center
  Coronado, California, United States Recruiting

+21 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pemvidutide for noncirrhotic MASH: a phase 3 study

  This phase 3 study tests pemvidutide versus placebo in adults with noncirrhotic MASH to see if it improves liver health and safety.

  Recruiting at 9 sites Phase 3 Altimmune, Inc. · North Little Rock, Arkansas and 8 other locations · NCT07795164

• VV-14303 for metabolic liver disease in adults with MASH

  This study tests VV-14303, a gene therapy, in adults with metabolic dysfunction-associated steatohepatitis (MASH) to see if it is safe and how well it works.

  Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Chandler, Arizona and 2 other locations · NCT07732400

• HRS-4729 and HRS9531 injections in adults with MASH

  This study tests whether HRS-4729 and HRS9531 injections (and their placebos) can help adults with metabolic dysfunction-associated steatohepatitis after 52 weeks of treatment.

  Recruiting at 2 sites Phase 2 Fujian Shengdi Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality and 1 other locations · NCT07660848

• Gut microbiota–derived amino acid metabolites in MASLD/MASH

  This study tests whether gut microbiota–produced amino acid metabolites are linked to MASLD/MASH in adults by collecting stool, blood, and urine samples and analyzing dietary factors.

  Recruiting Hospices Civils de Lyon · Pierre-Bénite · NCT07313007

• Patients' perspectives and needs in metabolic dysfunction‑associated steatohepatitis

  This study will see what adults with MASH expect, need, and feel about their care before and after taking part in a cardiovascular health program in Barcelona.

  Recruiting at 2 sites Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Barcelona and 1 other locations · NCT07188220

• UBT251 treatment for metabolic dysfunction-associated steatohepatitis (MASH)

  This trial will test whether daily UBT251 (2 mg, 4 mg, or 6 mg) for 48 weeks helps adults with biopsy-confirmed MASH and moderate fibrosis compared with placebo.

  Recruiting Phase 2 The United Bio-Technology (Hengqin) Co., Ltd. · Beijing, Beijing Municipality · NCT07145151

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.