New drug combo targets genetic fatty liver in Mid-Stage trial
NCT ID NCT07527910
First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times
Summary
This Phase 2a trial is testing a new drug called ALN-PNP, alone or with a weight-loss drug (tirzepatide), in 204 adults with a specific genetic form of fatty liver disease (MASLD). The goal is to see if lowering a certain liver protein can reduce liver fat. Participants must have a high liver fat level and a specific gene variant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ALN-PNP (a drug that lowers a protein linked to liver fat) and tirzepatide (a weight and blood sugar control drug)
- What this could lead to
- If successful, this could point toward a new treatment option for people with a genetic form of fatty liver disease, potentially reducing liver fat and improving liver health.
- What could go wrong
- This is an early Phase 2 trial with only 204 participants, so results may not apply to everyone. The drug may cause side effects or fail to reduce liver fat significantly.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 204 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: Part A and Part B: 1. Homozygous for the PNPLA3 p.I148M genotype 2. Liver fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥15% at visit 3 3. Has a Body Mass Index (BMI) ≥30 to \<45 kg/m\^2 at visit 2 Part A: To be eligible for randomization on study day 1: 1. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤3 × Upper Limit of Normal (ULN) as described in the protocol 2. On a stable dose of tirzepatide at randomization (≥5 mg weekly) Key Exclusion Criteria: 1. Evidence or diagnosis of portal hypertension or cirrhosis from any cause, including cirrhosis due to MASH, as determined by the investigator, based on medical history, clinical assessment, imaging, and/or liver biopsy 2. Known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol 3. Contraindications to MRI examinations, including but not limited to persons with MRI-incompatible cardiac pacemaker and implants made of metal, severe claustrophobia, size restrictions 4. Any contraindication listed in the Zepbound United States Prescribing Information (USPI), as defined in the protocol NOTE: Other protocol-defined inclusion/exclusion criteria apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Advanced Medical Trials
RECRUITINGGeorgetown, Texas, 78628, United States
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American Research Corporation
RECRUITINGAustin, Texas, 78757, United States
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American Research Corporation at The Texas Liver Institute
RECRUITINGSan Antonio, Texas, 78215, United States
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California Liver Research Institute
RECRUITINGPasadena, California, 91105, United States
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Southern California Research Center
RECRUITINGCoronado, California, 92118, United States
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Tandem Clinical Research, Plaza II
RECRUITINGMetairie, Louisiana, 70006, United States
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- Fatty liver study tracks 922 patients to uncover hidden risks