ALN-CIDEB-NASH-2486

• Research type

  Research Study

• Full title

  A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TWO-PART STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF A SINGLE DOSE OF ALN-CIDEB IN ADULT PARTICIPANTS WITH METABOLIC DYSFUNCTION-ASSOCIATED STEATOTIC LIVER DISEASE (MASLD) AND TWO DOSES OF ALN-CIDEB IN ADULT PARTICIPANTS WITH METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS (MASH)

• IRAS ID

  1010890

• Contact name

  Sean Smith

• Contact email

  sean.smith@regeneron.com

• Sponsor organisation

  Regeneron Pharmaceuticals Inc

• Clinicaltrials.gov Identifier

  NCT06836609

• Research summary

  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
  

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  25/LO/0148

• Date of REC Opinion

  27 Mar 2025

• REC opinion

  Further Information Favourable Opinion