Metabolic Dysfunction-Associated Steatotic Liver DiseasePhase 1/2NCT06836609
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
A Phase 1/2 study testing ALN-CIDEB in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis, run by Regeneron Pharmaceuticals at 4 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
- What is being tested?
- ALN-CIDEB
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 28 Apr 2025to 17 Aug 2027
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
- 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
- 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
- Part B: Screening percutaneous liver biopsy NAFLD Activity Score (NAS) ≥3 and fibrosis stage, as defined in the protocol
Who cannot join
- Known historical or current diagnosis of portal hypertension or cirrhosis based on clinical assessment, imaging, and/or liver biopsy
- 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 (MELD) score >12
- Contraindication to MRI examinations, such as persons with cardiac pacemaker and implants made of metal, severe claustrophobia, size restrictions, or other contraindications for MRI
- Liver stiffness measurement, laboratory parameter assessment, estimated Glomerular Filtration Rate (GFR), and evidence of uncontrolled hypertension, as defined in the protocol
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- 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
- History of Type 1 Diabetes
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Arizona Liver Health
Chandler, Arizona, 85225
Adobe Clinical Research
Tucson, Arizona, 85712
United Kingdom2 sites
Parexel International Early Phase Clinical Unit
Harrow, London, HA1 3UJ
Richmond Pharmacology Limited
London, Greater London, SE1 1YR
About this study
Official title: A Phase 1/2a, 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)
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.
Read more
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
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
- Being tested
- ALN-CIDEB, Placebo
- Keywords
- Obese, MASLD, MASH, Nonalcoholic fatty liver disease, NAFLD, Nonalcoholic Steatohepatitis, NASH, Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis, Steatotic liver disease, Fatty liver disease, Fibrotic MASH, Fatty liver, Liver inflammation, Early liver scarring
- Medical subject headings
- Obesity, Non-alcoholic Fatty Liver Disease, Fatty Liver, Hepatitis
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 |
|---|---|---|
| Part A | Experimental | Randomized per the protocol Receives: Drug: ALN-CIDEB; Drug: Placebo |
| Part B | Experimental | Randomized per the protocol Receives: Drug: ALN-CIDEB; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to 48 Weeks
Severity of TEAEs
Measured: Up to 48 Weeks
Secondary outcomes (8)
Change in liver fat fraction by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)
Measured: Baseline up to 48 Weeks
Total concentration of ALN-CIDEB in plasma
Measured: Up to 48 Weeks
Total concentration of potential major metabolite(s) in plasma
Measured: Up to 48 Weeks
Urinary recovery of ALN-CIDEB as a proportion of the dose
Part A
Measured: Up to 36 Weeks
Urinary recovery of potential major metabolite(s) as a proportion of the dose
Part A
Measured: Up to 36 Weeks
Change in Aspartate Aminotransferase (AST)
Measured: Baseline up to 48 Weeks
Change in Alanine Aminotransferase (ALT)
Measured: Baseline up to 48 Weeks
Change in hepatic Cell death-Inducing DNA fragmentation factor alpha-like Effector B (CIDEB) messenger RiboNucleic Acid (mRNA) level
Part B
Measured: Baseline up to 36 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start28 Apr 2025
- Primary completion17 Aug 2027 (estimated)
- Study completion17 Aug 2027 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part A: Sequential Assignment and Part B: Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (actual)
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
- NCT06836609
- Sponsor's protocol ID
- ALN-CIDEB-NASH-2486
- Status last verified
- Oct 2026
- First submitted
- 14 Feb 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, 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)
- ClinicalTrials.gov ID
- NCT06836609
- Acronym / sponsor ID
- ALN-CIDEB-NASH-2486
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
- Keywords
- Obese, MASLD, MASH, Nonalcoholic fatty liver disease, NAFLD, Nonalcoholic Steatohepatitis, NASH, Metabolic Dysfunction-Associated Steatotic Liver Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 17 Aug 2027 (estimated)
- Study completion
- 17 Aug 2027 (estimated)
- First posted
- 20 Feb 2025 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Part A: Sequential Assignment and Part B: Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: ALN-CIDEB, Drug: PlaceboRandomized per the protocol |
| Part B | Experimental | Drug: ALN-CIDEB, Drug: PlaceboRandomized per the protocol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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
- 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
Key exclusion criteria (10 listed)
- Known historical or current diagnosis of portal hypertension or cirrhosis based on clinical assessment, imaging, and/or liver biopsy
- 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 (MELD) score >12
- Contraindication to MRI examinations, such as persons with cardiac pacemaker and implants made of metal, severe claustrophobia, size restrictions, or other contraindications for MRI
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 | Part A, Part B |
| PlaceboAdministered per the protocol | Drug | Part A, Part B |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 48 Weeks
Severity of TEAEs
Time frame: Up to 48 Weeks
8 secondary outcomes
Change in liver fat fraction by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)
Time frame: Baseline up to 48 Weeks
Total concentration of ALN-CIDEB in plasma
Time frame: Up to 48 Weeks
Total concentration of potential major metabolite(s) in plasma
Time frame: Up to 48 Weeks
Urinary recovery of ALN-CIDEB as a proportion of the dose
Time frame: Up to 36 Weeks
Urinary recovery of potential major metabolite(s) as a proportion of the dose
Time frame: Up to 36 Weeks
Change in Aspartate Aminotransferase (AST)
Time frame: Baseline up to 48 Weeks
Change in Alanine Aminotransferase (ALT)
Time frame: Baseline up to 48 Weeks
Change in hepatic Cell death-Inducing DNA fragmentation factor alpha-like Effector B (CIDEB) messenger RiboNucleic Acid (mRNA) level
Time frame: Baseline up to 36 Weeks
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 4 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. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALN-CIDEB in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis, run by Regeneron Pharmaceuticals at 4 sites in 2 countries.
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 7 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 4 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 4 sites in United States, United Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to 48 Weeks). 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 4 Nov 2026.