A Phase 2 interventional study of ALN-PNP and Tirzepatide in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), sponsored by Regeneron Pharmaceuticals. Recruiting at 9 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment
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Among 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States — 60 open to participants now, 93 under way, 13 of them phase 3. Non-alcoholic Fatty Liver Disease · United States.
Among the 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States, this one is the 76th largest by planned enrollment of the 460 interventional ones that give a count, is one of 8 that started in 2026, is one of 192 in phase 2, reaches primary completion later than 82 of the 92 other live ones, and was the 544th registered.
1,618 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 323 are open to participants now.
Browse Non-alcoholic Fatty Liver Disease studies →60 of the 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United States
Ages 18–75
Regeneron Pharmaceuticals · Sites in United States, Puerto Rico, United Kingdom
Ages 18–75
Columbia University · Sites in United States
Ages 18–65
GlaxoSmithKline · Sites in United States
Ages 18–70
Eccogene · Sites in United States
Ages 18–75
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 220 Non-alcoholic Fatty Liver Disease studies recruiting now, 66 (30%) set no upper age limit and 125 (57%) stop at 75 or younger; 27 take children under 18; 55 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
547 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 93 · Phase 2 213 · Phase 3 36 · Phase 4 13
First in 2000; this study’s year is marked. 8 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 204 is above the median of 60 across 1,177 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Median enrollment 56 across the 460 interventional studies, 90 across the 85 observational. Of the 420 that completed or were terminated, 215 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
246 of 547 have an industry lead sponsor. The 10 most frequent:
Regeneron Pharmaceuticals is the lead sponsor of 412 studies on the registry; 90 are open to participants now.
Of its 126 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
Regeneron Pharmaceuticals has 9 studies filed under Non-alcoholic Fatty Liver Disease — fewer than ten, so there is no comparison to draw.
22 of the studies in Non-alcoholic Fatty Liver Disease with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04951219Phase 3Madrigal Pharmaceuticals, Inc.A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE) | 2027-03 |
| NCT04833140Phase 3Massachusetts General HospitalEstrogen Administration for the Treatment of NASH in Postmenopausal Women | 2027-07-09 |
| NCT00983463Vanderbilt UniversityAbundance and Distribution of Lipids and Proteins in Nonalcoholic Fatty Liver Disease (NAFLD) | 2026-11 |
| NCT05165706Stanford UniversityLongitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance | 2026-11-30 |
| NCT05067621Yale UniversitySemaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease | 2026-12 |
Add all 22 to your calendar (.ics) → With an account.
Among the 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will test a study drug called ALN-PNP with and without another drug that is used for controlling blood sugar, appetite, and weight (for example, tirzepatide), to see if it can help treat MASLD, also known as fatty liver disease. ALN-PNP reduces the amount of Patatin-like phospholipase domain-containing protein 3 (PNPLA3), a protein that liver cells make, which may help decrease liver fat if there is an abnormal PNPLA3 protein.
The goal of this study is to understand the effect of ALN-PNP with or without tirzepatide on reducing liver fat.
The study is looking at:
Key Inclusion Criteria:
Part A and Part B:
Part A: To be eligible for randomization on study day 1:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: ALN-PNP · Drug: Tirzepatide
Drug: Tirzepatide · Drug: Placebo
Drug: ALN-PNP · Drug: Tirzepatide
Drug: Tirzepatide · Drug: Placebo
Drug: ALN-PNP
Drug: Placebo
Administered per the protocol
Administered per the protocol
Also known as: Zepbound®
Administered per the protocol Placebo matching ALN-PNP
Percent change in liver fat
Part A
Time frame: From baseline at week 24
Percent change in liver fat
Part B
Time frame: From baseline at week 48
Achievement of liver fat <5%
Time frame: At weeks 24 and 48
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through week 72
Severity of TEAEs
Time frame: Through week 72
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: When Regeneron has: received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) the legal authority to share the data, and ensured the ability to protect participant privacy
Access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Mar 2030, 45 months after the start.
Of 132 industry-sponsored phase 2 interventional studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 30. This study's planned 45 months is above that.
Counting every sponsor, half of 185 studies reached it within 26 months; a quarter within 16 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Non-alcoholic Fatty Liver Disease →