Actively Recruiting
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Effects of ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease and Steatohepatitis
Led by Regeneron Pharmaceuticals · Updated on 2026-04-27
132
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an experimental drug called ALN-CIDEB in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) or metabolic dysfunction-associated steatohepatitis (MASH). These are long-lasting liver conditions caused by too much fat in the liver. The study aims to understand how safe and tolerable ALN-CIDEB is, along with exploring side effects and how the drug affects liver fat and its presence in the blood. The study includes two parts: Part A focuses on participants with MASLD and Part B on those with MASH. Participants receive either ALN-CIDEB or a placebo, with dosing and administration following the study protocol. The trial is randomized and double-blind, meaning neither participants nor researchers know which treatment is given. The study observes the effects up to 48 weeks, including drug metabolism and liver-related measures. Participants will undergo various assessments such as Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) to measure liver fat, blood tests to monitor drug levels and liver enzymes, and other evaluations of liver health and response. The study tracks treatment-emergent adverse events and liver function changes over 48 weeks. Participant involvement includes multiple visits for monitoring safety, drug effects, and liver condition changes during this period.
CONDITIONS
Brief 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 with MASLD
- Part B: Age 18 to 65 years with a diagnosis of MASH
- Body Mass Index (BMI) between 30 and 40 kg/m2
- Controlled-Attenuation Parameter (CAP) of 285 dB/m or higher by FibroScan
- Liver fat content of at least 8.5% by MRI-PDFF
- Stable doses of anti-hypertensive, lipid lowering, and/or glucose lowering medications for at least 12 weeks prior
- Part B: Diagnosis of MASH confirmed by medical history or clinical suspicion with risk factors
- Part B: Liver biopsy with NAFLD Activity Score (NAS) of 3 or more and fibrosis stage as defined in the protocol
You will not qualify if you...
- Known diagnosis of portal hypertension or cirrhosis
- Known diagnosis of other chronic liver diseases
- Prior or current drug-induced liver injury within 1 year before screening
- History of liver transplant or being on liver transplant list with MELD score over 12
- Contraindications to MRI such as pacemaker, metal implants, or severe claustrophobia
- Uncontrolled hypertension or impaired kidney function
- Evidence of HIV, Hepatitis B, or Hepatitis C infection
- History of Type 1 Diabetes
- Bariatric surgery within about 5 years prior or planned during the study period
- Other protocol-defined criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 48 weeks
Participants receive ALN-CIDEB or placebo according to the study protocol to evaluate safety and effects.
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
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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