Metabolic Dysfunction-Associated Steatotic Liver DiseasePhase 3NCT07854782
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A Phase 3 study testing ALN-CIDEB in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and MASLD, run by Regeneron Pharmaceuticals at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
- What is being tested?
- ALN-CIDEB
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2026to 3 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Has prior, current, or planned future use (during the treatment period) of a GLP-1 receptor agonist-based therapy or any medication approved for the treatment of MASH (eg, resmetirom) unless used at a generally stable dose and regimen since at least 3 months prior to screening visit and throughout the screening period with no change to the dose or regimen anticipated during the treatment period, as defined in the protocol
- Has evidence of uncontrolled human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection during screening, as defined in the protocol
- NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Advanced Medical Trials
Georgetown, Texas, 78628
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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
- Being tested
- ALN-CIDEB, Placebo
- Keywords
- NAFLD, NASH, Metabolic Dysfunction-Associated Steatohepatitis, MASH, Fatty Liver Disease, Non-alcoholic Fatty Liver Disease, Liver Fibrosis, Steatotic Liver Disease, SLD, Metabolic Fatty Liver Disease, Hepatic Steatosis, Fatty Liver, Liver Fat, Excess Liver Fat, Obesity, Insulin Resistance
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis, Fatty Liver, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALN-CIDEBDrug
Administered per the protocol
PlaceboDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| ALN-CIDEB Dose Level 1 | Experimental | Not described Receives: Drug: ALN-CIDEB |
| ALN-CIDEB Dose Level 2 | Experimental | Not described Receives: Drug: ALN-CIDEB |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Measured: Through Week 64
Severity of TEAEs
Measured: Through Week 64
Secondary outcomes (4)
Change from Baseline in FibroScan Controlled Attenuation Parameter (CAP)
Measured: At Week 52
Change from Baseline in FibroScan Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE)
Measured: At Week 52
Change from Baseline in Aspartate Aminotransferase (AST)
Measured: Through Week 64
Change from Baseline in Alanine Aminotransferase (ALT)
Measured: Through Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start28 Oct 2026
- Primary completion3 Mar 2029 (estimated)
- Study completion3 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854782
- Sponsor's protocol ID
- ALN-CIDEB-MASLD-2604
- Other IDs
- 2026-526723-22-00
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
- ClinicalTrials.gov ID
- NCT07854782
- Acronym / sponsor ID
- ALN-CIDEB-MASLD-2604
- Keywords
- NAFLD, NASH, Metabolic Dysfunction-Associated Steatohepatitis, MASH, Fatty Liver Disease, Non-alcoholic Fatty Liver Disease, Liver Fibrosis, Steatotic Liver Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2026 (actual)
- Primary completion
- 3 Mar 2029 (estimated)
- Study completion
- 3 Mar 2029 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALN-CIDEB Dose Level 1 | Experimental | Drug: ALN-CIDEB |
| ALN-CIDEB Dose Level 2 | Experimental | Drug: ALN-CIDEB |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- Has prior, current, or planned future use (during the treatment period) of a GLP-1 receptor agonist-based therapy or any medication approved for the treatment of MASH (eg, resmetirom) unless used at a generally stable dose and regimen since at least 3 months prior to screening visit and throughout the screening period with no change to the dose or regimen anticipated during the treatment period, as defined in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALN-CIDEBAdministered per the protocol | Drug | ALN-CIDEB Dose Level 1, ALN-CIDEB Dose Level 2 |
| PlaceboAdministered per the protocol | Drug | Placebo |
Primary outcome
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Through Week 64
Severity of TEAEs
Time frame: Through Week 64
4 secondary outcomes
Change from Baseline in FibroScan Controlled Attenuation Parameter (CAP)
Time frame: At Week 52
Change from Baseline in FibroScan Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE)
Time frame: At Week 52
Change from Baseline in Aspartate Aminotransferase (AST)
Time frame: Through Week 64
Change from Baseline in Alanine Aminotransferase (ALT)
Time frame: Through Week 64
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ALN-CIDEB in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and MASLD, run by Regeneron Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Treatment Emergent Adverse Events (TEAEs) (time frame: Through Week 64). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.