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Experimental drug for cholesterol and fatty liver fails to advance

NCT ID NCT06007651

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-stage trial tested a new drug called LY3885125 in people with high cholesterol (dyslipidemia) and non-alcoholic fatty liver disease (NAFLD). The main goal was to check safety and how the body processes the drug. The study was terminated, meaning it stopped early, so its potential remains unclear.

What this could mean

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

Active substance
LY3885125
What this could lead to
If successful, this could point toward a new treatment option for managing high cholesterol and fatty liver disease.
What could go wrong
This was a very early (Phase 1) trial focused on safety, not effectiveness. The study was terminated, so results may not be available or may not support further development.

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

49 people

The number who actually took part.

Started

Aug 2023

Finished

Feb 2025

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: Parts A \& B * Males, or females of not of childbearing potential, * On a stable diet for the 3 months prior to randomization and willing to continue the same stable diet during the study. Part A * Dyslipidemia with the following fasted blood levels at screening: 150 mg/dL ≤ triglycerides \<500 mg/dL, AND LDL-cholesterol ≥100 mg/dL, * Body mass index (BMI) in range of 18.5 to 45.0 kg/m2. Part B * NAFLD with liver fat content ≥8% as determined by magnetic resonance imaging proton density fat fraction (MRI-PDFF), * BMI in range of 27 to 45.0 kg/m2 Exclusion Criteria: Parts A \& B * History or presence of medical illness including, but not limited to, any cardiovascular, thromboembolism or bleeding disorder, hepatic, respiratory, hematological, endocrine, immune, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the Investigator, indicate a medical problem that would preclude study participation, * Uncontrolled hypertension with a resting blood pressure ≥ 160 mmHg systolic or ≥ 100 mmHg diastolic at visit 1, * Alanine transaminase (ALT) or aspartate aminotransferase (AST) \>3.0 × ULN for the reference range, * Alkaline phosphatase (ALP) \>1.5 × ULN for the reference range, * Total bilirubin (TBL) \>1.5 × ULN for the reference range, * Taken drugs associated with hepatic steatosis (e.g., amiodarone, valproic acid, methotrexate, tamoxifen) for more than 2 weeks in the 3 months prior to screening visit, * Type 1 diabetes mellitus (T1DM) or any other type of diabetes mellitus other than T2DM, * Poorly controlled T2DM with glycated hemoglobin (HbA1c) of \>9.0%, * Treatment with GLP-1 RA and GIP/GLP-1 RA and approved or experimental agents that target PCSK9 within 9 months prior to screening visit. Part B * Evidence of other forms of chronic liver disease, * Initiated treatment with, or changed dose of, medications that may cause significant weight gain or weight loss, within 3 months prior to the screening visit, * Have a self-reported change in body weight \>5 kg (11 pounds) within 3 months prior to screening visit

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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.

Contacts and locations

Locations

  • Worldwide Clinical Trials, Inc.

    San Antonio, Texas, 78217, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.