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Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

ConditionsMetabolic Dysfunction-Associated Steatotic Liver DiseaseMASLD
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRegeneron Pharmaceuticals

About this trial

This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called metabolic dysfunction-associated steatohepatitis (MASH). MASH is more advanced stage of a broader liver disease, MASLD. MASLD is a liver condition caused by too much fat building up in the liver. This can lead to liver scarring and inflammation and can reduce the liver's ability to keep the body healthy. Cell death-inducing DFFA-like effector B (CIDEB) is a protein made by liver cells that helps the liver to store fat.

The study is looking at:

* What side effects ALN-CIDEB might cause * How well ALN-CIDEB works to change liver fat, liver injury, and liver scarring * How ALN-CIDEB could affect the body and the liver, which can help researchers understand why ALN-CIDEB works better for some people than others

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has a clinical diagnosis of MASLD, as defined in the protocol

Has a liver stiffness measurement between 6 and 20 kilopascals (kPa), as measured by a FibroScan® scan during screening or within approximately 3 months of screening, as defined in the protocol

Disqualifiers

Has a known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol

Has prior or current suspected or known drug-induced liver injury within approximately 1 year prior to screening

Has a history of liver transplantation, current placement on a liver transplant list, or Model for End-Stage Liver Disease (MELD) score >12

Has a known history of alcohol or other substance abuse within the last year or at any time during screening based on investigator's discretion

Trial design

Design model

Parallel

Treatments tested in this trial

  • ALN-CIDEB

    Drug

    Administered per the protocol

  • Placebo

    Drug

    Administered per the protocol

Treatment groups

1,500 Participants
are divided into 3 treatment groups
Group A: ALN-CIDEB Dose Level 1Experimental treatment 1 intervention
Group B: ALN-CIDEB Dose Level 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Occurrence of Treatment Emergent Adverse Events (TEAEs)

Time frame
Through Week 64
2

Severity of TEAEs

Time frame
Through Week 64

Secondary outcomes

1

Change from Baseline in FibroScan Controlled Attenuation Parameter (CAP)

Time frame
At Week 52
2

Change from Baseline in FibroScan Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE)

Time frame
At Week 52
3

Change from Baseline in Aspartate Aminotransferase (AST)

Time frame
Through Week 64
4

Change from Baseline in Alanine Aminotransferase (ALT)

Time frame
Through Week 64

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: