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New drug targets fatty liver in genetically At-Risk patients

NCT ID NCT05395481

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tested a new drug, LY3849891, in 115 people with fatty liver disease who carry a specific gene variant (PNPLA3 I148M). The main goal was to check safety and how the body processes the drug. Researchers also looked at changes in liver fat and inflammation using MRI and blood tests. The study lasted up to 32 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY3849891
What this could lead to
If successful, this could point toward a treatment for fatty liver disease in people with a specific genetic risk factor.
What could go wrong
This is an early Phase 1 trial focused on safety, not proof of effectiveness. The drug may not work or could have side effects. It only applies to people with the PNPLA3 I148M gene variant.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

115 people

The number who actually took part.

Started

Jun 2022

Finished

May 2026

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must have a body mass index (BMI) within the range greater than or equal to (≥) 25 and less than (\<) 50 kilogram per square meter (kg/m²) inclusive * Participants must have liver fat content ≥10% in Part A and ≥8% for Part B as determined by MRI-PDFF * Participants must be carriers of the PNPLA3 I148M allele * Participants with or without type 2 diabetes mellitus (T2DM) o For participants with T2DM, hemoglobin A1c (HbA1c) \<8% in Part A and \<9% in Part B * Male participants agree to use an effective method of contraception for the duration of the study and for 90 days after the last dose of study intervention * Women not of childbearing potential may participate and include those who are: infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or those who are postmenopausal Exclusion Criteria: * Participants must not have known or suspected alcohol abuse (\>14 units/week for women and \>21 units/week for men) or active substance abuse * Participants must not have evidence of cirrhosis or other forms of liver disease * Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 3 months * Participants must not have active cancer within the last 5 years * Participants must not have uncontrolled high blood pressure * Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) \<60 milliliter per minute per 1.73 square meter (ml/min/1.73m²) * Participants must not have a diagnosis of type 1 diabetes * Participants must not have a contraindication to MRI examinations, such as persons with cardiac pacemaker and implants made out of metal (for example, cochlear implant, nerve stimulators, magnetic vascular clips, and metallic heart valve) or other contraindications for MRI

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver fatty liver disease metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metabolic dysfunction associated steatohepatitis (MASH) Metabolic dysfunction-associated steatotic liver disease (masld)

Contacts and locations

Locations

  • Accel Research Sites - Maitland

    Maitland, Florida, 32751, United States

  • Advanced Pharma Clinical Research

    Miami, Florida, 33175, United States

  • Arizona Liver Health - Chandler

    Chandler, Arizona, 85225, United States

  • Charter Research - Winter Park

    Orlando, Florida, 32803, United States

  • Clinical Research Hospital Tokyo

    Shinjuku-ku, 160-0004, Japan

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229, United States

  • Evolution Clinical Trials, Inc

    Miami, Florida, 33122, United States

  • FDI Clinical Research

    San Juan, 00927, Puerto Rico

  • Floridian Clinical Research

    Miami Lakes, Florida, 33016, United States

  • Houston Research Institute

    Houston, Texas, 77079, United States

  • IU Health University Hospital

    Indianapolis, Indiana, 46290, United States

  • Inland Empire Clinical Trials, LLC

    Rialto, California, 92377, United States

  • Orange County Research Center

    Orange, California, 92868, United States

  • P-One Clinic

    Hachiōji, 192-0071, Japan

  • Pinnacle Clinical Research

    San Antonio, Texas, 78229, United States

  • Synergy Healthcare LLC

    Brandon, Florida, 33511, United States

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