Experimental drug for cholesterol and fatty liver fails to advance
NCT ID NCT06007651
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 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.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Dyslipidemias are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
- Underactive thyroid may worsen liver scarring in fatty liver disease
- Can one workout a week melt liver fat?
- Ten-Year liver study asks: what makes fatty liver disease progress?
- Can a liver drug also protect the heart? study tests ursodeoxycholic acid in fatty liver disease
- Ketogenic diet vs mediterranean diet: which better reshapes metabolism?
- Can a simple scan reveal hidden liver damage in diabetes patients?