A Study of LY3885125 in Participants with Dyslipidemia or Non-Alcoholic Fatty Liver Disease (NAFLD)

Lilly

Status and phase: Terminated; Phase 1

Conditions: Dyslipidemias; Non-Alcoholic Fatty Liver Disease

Treatments: Drug: Placebo; Drug: LY3885125

Study type: Interventional

Funder types: Industry

Identifiers

NCT06007651

J4N-MC-YFAA (Other Identifier)

18769

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety and tolerability of LY3885125 after administration of single ascending doses in participants with dyslipidemia (part A) and multiple doses in participants with non-alcoholic fatty liver disease (part B). Blood tests will be performed to check how much LY3885125 gets into the bloodstream and how long it takes the body to eliminate it.

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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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49 participants in 4 patient groups, including a placebo group

LY3885125 (Part A)

Experimental group

Description:

Single ascending doses of LY3885125 administered subcutaneously (SC)

Treatment:

Drug: LY3885125

Placebo (Part A)

Placebo Comparator group

Description:

Placebo administered SC

Treatment:

Drug: Placebo

LY3885125 (Part B)

Experimental group

Description:

Repeat doses of LY3885125 administered SC

Treatment:

Drug: LY3885125

Placebo (Part B)

Placebo Comparator group

Description:

Placebo administered SC

Treatment:

Drug: Placebo