Actively Recruiting
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Led by Regeneron Pharmaceuticals · Updated on 2026-04-27
132
Participants Needed
3
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is researching an experimental drug called ALN-CIDEB, also referred to as "study drug". The study is focused on participants with metabolic dysfunction-associated steatotic liver disease (MASLD) (Part A) and metabolic dysfunction-associated steatohepatitis (MASH) (Part B). MASLD and MASH are long-lasting liver conditions caused by having too much fat in the liver. The aim of the study is to see how safe and tolerable the study drug is. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How the study drug works to change liver fat content * How much study drug and study drug metabolites (byproducts of the body breaking down the study drug) are in the blood at different times
CONDITIONS
Official Title
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Part A: Age 18 to 55 years at screening with MASLD
- Part B: Age 18 to 65 years at screening with diagnosis or suspicion of MASH
- Body Mass Index (BMI) between 30 and 40 kg/m2 at screening
- Controlled-Attenuation Parameter (CAP) ≥285 dB/m by FibroScan during screening
- Liver fat content ≥8.5% by MRI-PDFF during screening
- Stable doses of anti-hypertensive, lipid lowering, or glucose lowering medications for at least 12 weeks before screening
- Part B: Diagnosis of MASH confirmed by medical history or clinical suspicion with metabolic syndrome factors
- Part B: Percutaneous liver biopsy showing NAFLD Activity Score (NAS) ≥3 and fibrosis stage as defined in protocol
You will not qualify if you...
- Known current or past diagnosis of portal hypertension or cirrhosis
- Known current or past diagnosis of other chronic liver diseases
- Suspected or known drug-induced liver injury within 1 year prior to screening
- History of liver transplant, current liver transplant listing, or MELD score >12
- Contraindications to MRI such as pacemakers, metal implants, severe claustrophobia, or size limits
- Uncontrolled hypertension or abnormal liver stiffness and kidney function as defined in protocol
- Evidence of HIV, Hepatitis B, or Hepatitis C infection during screening
- History of Type 1 Diabetes
- Bariatric surgery within approximately 5 years before randomization or planned during study
- Other protocol-defined exclusion criteria apply
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Arizona Liver Health
Chandler, Arizona, United States, 85225
Actively Recruiting
2
Richmond Pharmacology Limited
London, Greater London, United Kingdom, SE1 1YR
Actively Recruiting
3
Parexel International Early Phase Clinical Unit
Harrow, London, United Kingdom, HA1 3UJ
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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