A Study of LY3885125 in Participants With Dyslipidemia or Non-Alcoholic Fatty Liver Disease (NAFLD)
NCT ID: NCT06007651
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
49 participants
INTERVENTIONAL
2023-08-10
2025-02-12
Brief Summary
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The study will last up to approximately 49 weeks for part A and 62 weeks for part B, for a total of approximately 111 weeks.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
DOUBLE
Study Groups
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LY3885125 (Part A)
Single ascending doses of LY3885125 administered subcutaneously (SC)
LY3885125
Administered SC
Placebo (Part A)
Placebo administered SC
Placebo
Administered SC
LY3885125 (Part B)
Repeat doses of LY3885125 administered SC
LY3885125
Administered SC
Placebo (Part B)
Placebo administered SC
Placebo
Administered SC
Interventions
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LY3885125
Administered SC
Placebo
Administered SC
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Worldwide Clinical Trials, Inc.
San Antonio, Texas, United States
Countries
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Other Identifiers
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J4N-MC-YFAA
Identifier Type: OTHER
Identifier Source: secondary_id
18769
Identifier Type: -
Identifier Source: org_study_id
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