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Looking for participantsPhase1/Phase2

A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)

Sponsor: Regeneron Pharmaceuticals

NCT ID: NCT06836609

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
ALN-CIDEB (drug), Placebo (drug)
How long the study runs
Study runs about 25 months (dates as stated)
About the drug or intervention
ALN-CIDEB — drug: Administered per the protocol · Placebo — drug: Administered per the protocol
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a medicine called ALN-CIDEB in adults with MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease) or MASH (Metabolic Dysfunction-Associated Steatohepatitis) — conditions where fat builds up in the liver. The study has two parts: Part A includes people with MASLD aged 18 to 55, and Part B includes people with MASH aged 18 to 65. It is run by Regeneron Pharmaceuticals.

Who can take part

  • Adults aged 18 to 55 with MASLD (Part A), or 18 to 65 with MASH (Part B)
  • Body mass index (BMI) between 30 and 40
  • A certain level of liver fat, shown by a liver scan (FibroScan) and an MRI scan
  • Part B only: MASH confirmed by medical history or signs such as fatty liver on scans and raised liver enzymes, plus 2 or more features of metabolic syndrome
  • Part B only: a liver biopsy sample taken during screening meeting certain study requirements
  • If you take medicines for blood pressure, cholesterol or blood sugar, the dose must have been stable for at least 12 weeks and not expected to change

Who may not be able to

  • Portal hypertension (high pressure in the liver's blood vessels) or cirrhosis (severe scarring of the liver)
  • Other types of long-term liver disease
  • Suspected or known medicine-related liver injury within the past year
  • Past liver transplant, being on a liver transplant list, or a MELD score above 12
  • Unable to have MRI scans, for example due to a pacemaker, metal implants, or severe claustrophobia
  • Certain liver stiffness, blood test or kidney function results, or uncontrolled high blood pressure, as set out in the study rules
  • HIV, hepatitis B or hepatitis C infection found during screening
  • Type 1 diabetes
  • Weight-loss (bariatric) surgery within about the past 5 years or planned during the study

What taking part involves

  • • Taking the study medicine ALN-CIDEB — details of how it is given are not stated, ask the trial team
  • • Screening checks including a liver scan (FibroScan), an MRI scan to measure liver fat, and blood tests
  • • Part B only: a liver biopsy (a small sample of liver tissue) during screening

Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 65 Years
Who
All
Number of participants
132
Started
2025-04-28
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for metabolic dysfunction-associated steatotic liver disease
  • • Phase1/Phase2 - 132 participants
  • • This study is researching an experimental drug called ALN-CIDEB, also referred to as "study drug"

Who can take part?

  • • Ages 18 Years to 65 Years
  • • Diagnosed with metabolic dysfunction-associated steatotic liver disease

Where?

  • • London - Richmond Pharmacology Limited
  • • Harrow - Parexel International Early Phase Clinical Unit

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Metabolic Dysfunction-Associated Steatotic Liver DiseaseMetabolic Dysfunction-Associated Steatohepatitis

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 65 Years
  • Who can join: All genders

What the study is looking for

  • ✓Part A: 18 to 55 years at Screening Visit 1 with MASLD, at Screening Visit 1 Part B: 18 to 65 years at Screening...
  • ✓Body Mass Index (BMI) ≥30 kg/m2 and ≤40 kg/m2 at Screening Visit 1
  • ✓Controlled-Attenuation Parameter (CAP) ≥285 dB/m by FibroScan during screening as described in the protocol
  • ✓Liver fat content ≥8.5% by MRI-PDFF during screening
  • ✓Part B: Screening percutaneous liver biopsy NAFLD Activity Score (NAS) ≥3 and fibrosis stage, as defined in the protocol

Who cannot take part

  • ✗Known historical or current diagnosis of portal hypertension or cirrhosis based on clinical assessment, imaging,...
  • ✗Known historical or current diagnosis of other forms of chronic liver disease, as defined in the protocol
  • ✗Prior or current suspected or known drug-induced liver injury within 1 year prior to screening
  • ✗History of liver transplant, current placement on a liver transplant list, or Model for End-stage Liver Disease...
  • ✗safety concern to MRI examinations, such as persons with heart pacemaker and implants made of metal, severe...
See the full criteria
Key Inclusion Criteria: 1. Part A: 18 to 55 years at Screening Visit 1 with MASLD, at Screening Visit 1 Part B: 18 to 65 years at Screening Visit 1 with a diagnosis of MASH, at Screening Visit 1 2. Body Mass Index (BMI) ≥30 kg/m2 and ≤40 kg/m2 at Screening Visit 1 3. Controlled-Attenuation Parameter (CAP) ≥285 dB/m by FibroScan during screening as described in the protocol 4. Liver fat content ≥8.5% by MRI-PDFF during screening 5. If on anti-hypertensive and/or lipid lowering medications and/or glucose lowering medications, must be on generally stable dose(s) for at least 12 weeks prior to screening and no changes to the dose(s) are anticipated during the study 6. Part B: A diagnosis of MASH documented in the participant's medical history, or a clinical suspicion of MASH based on non-invasive biomarkers (eg, evidence of fatty liver on imaging and elevated liver enzymes) and clinical risk factors, including having a history of 2 or more elements of metabolic syndrome, as defined in the protocol 7. Part B: Screening percutaneous liver biopsy NAFLD Activity Score (NAS) ≥3 and fibrosis stage, as defined in the protocol Key Exclusion Criteria: 1. Known historical or current diagnosis of portal hypertension or cirrhosis based on clinical assessment, imaging, and/or liver biopsy 2. Known historical or current diagnosis of other forms of chronic liver disease, as defined in the protocol 3. Prior or current suspected or known drug-induced liver injury within 1 year prior to screening 4. History of liver transplant, current placement on a liver transplant list, or Model for End-stage Liver Disease (MELD) score \>12 5. Contraindication to MRI examinations, such as persons with cardiac pacemaker and implants made of metal, severe claustrophobia, size restrictions, or other contraindications for MRI 6. Liver stiffness measurement, laboratory parameter assessment, estimated Glomerular Filtration Rate (GFR), and evidence of uncontrolled hypertension, as defined in the protocol 7. Evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B Virus (HBV) infection, or Hepatitis C Virus (HCV) infection during screening, as described in the protocol 8. History of Type 1 Diabetes 9. Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions, within approximately 5 years prior to randomization or planned during the study period NOTE: Other protocol-defined inclusion/exclusion criteria apply.

Where Is This Study? (2 UK sites)

Richmond Pharmacology Limited

London SE1 1YR, United Kingdom

Recruiting

Parexel International Early Phase Clinical Unit

Harrow HA1 3UJ, United Kingdom

Recruiting

How to Get in Touch

Clinical Trials Administrator

Sponsor contact

CONTACT

844-734-6643 clinicaltrials@regeneron.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07