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

NCT06007651 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 18769J4N-MC-YFAA
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyslipidemias; Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (2)

• Part A: Number of Participants With One or More Serious Adverse Event(s) 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 36 weeks (Part A)

• 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 36 weeks (Part B)

Secondary Outcomes (6)

• Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3885125

  Baseline up to 36 weeks (Part A)

• Part A: PK: Maximum Observed Plasma Concentration (Cmax) of LY3885125

  Baseline up to 36 weeks (Part A)

• Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3885125

  Baseline up to 36 weeks (Part A)

• Part A: Pharmacodynamics (PD): Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)

  Baseline up to Day 169 (Part A)

• Part A: PD: Change From Baseline in Apolipoprotein B (ApoB)

  Baseline up to Day 169 (Part A)

Study Arms (4)

LY3885125 (Part A)

EXPERIMENTAL

Single ascending doses of LY3885125 administered subcutaneously (SC)

Drug: LY3885125

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

LY3885125 (Part B)

EXPERIMENTAL

Repeat doses of LY3885125 administered SC

Drug: LY3885125

Placebo (Part B)

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Interventions

LY3885125 DRUG

Administered SC

LY3885125 (Part A); LY3885125 (Part B)

Placebo DRUG

Administered SC

Placebo (Part A); Placebo (Part B)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Worldwide Clinical Trials, Inc.

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Dyslipidemias; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Eli Lilly
• Organization: Eli Lilly and Company

LillyTrials@lilly.com

1-877-285-4559

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 23, 2023
• Study Start: August 10, 2023
• Primary Completion: February 12, 2025
• Study Completion: February 12, 2025
• Last Updated: April 13, 2026
• Results First Posted: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)