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

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

A Phase 1, Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial of LY3885125 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Ascending Dose in Participants With Dyslipidemia and Repeat-Doses in Participants With NAFLD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06007651
• Other study ID #: 18769
• Secondary ID: J4N-MC-YFAA
• Status: Recruiting
• Phase: Phase 1
• Start date: August 10, 2023
• Est. completion date: April 15, 2025

Study information

• Verified date: October 2023
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]Lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: April 15, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• LY3885125
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
United States	Worldwide Clinical Trials, Early Phase Services LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Part A: A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline up to 49 weeks (Part A)
Primary	Part B: Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration	Part B: A summary of SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module	Baseline up to 62 weeks (Part B)
Secondary	Part A & B: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3885125	Part A & B: PK: AUC of LY3885125	Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)
Secondary	Part A & B: PK: Maximum Observed Plasma Concentration (Cmax) of LY3885125	Part A & B: PK: Cmax of LY3885125	Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)
Secondary	Part A & B: PK: Time of Maximum Observed Concentration (Tmax) of LY3885125	Part A & B: PK: Tmax of LY3885125	Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)
Secondary	Part A & B: Pharmacodynamics (PD): Change From Baseline in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9)	Part A & B: PD: Change From Baseline in PCSK9	Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)
Secondary	Part A & B: PD: Change From Baseline in apolipoprotein B (ApoB)	Part A & B: PD: Change From Baseline in ApoB	Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)
Secondary	Part B only: PD: Change of Liver Fat Content From Baseline by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)	Part B only: PD: Change of Liver Fat Content From Baseline by MRI-PDFF	Baseline up to 62 weeks (Part B)