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

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06836609
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • ALN-CIDEB — DRUG
    Administered per the protocol
  • Placebo — DRUG
    Administered per the protocol

Study Details

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

Key Dates

Start date
Apr 28, 2025
Status verified
Apr 2026
Primary completion
May 15, 2027
Completion
May 15, 2027

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A
    Randomized per the protocol
  • Experimental: Part B
    Randomized per the protocol

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 48 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Arizona Liver HealthChandlerArizona85225-

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By research site
Arizona Liver Health· Chandler, AZ

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