search
Back to results

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

Primary Purpose

Dyslipidemias, Non-Alcoholic Fatty Liver Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3885125
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dyslipidemias

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Worldwide Clinical Trials, Early Phase Services LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

LY3885125 (Part A)

Placebo (Part A)

LY3885125 (Part B)

Placebo (Part B)

Arm Description

Single ascending doses of LY3885125 administered subcutaneously (SC)

Placebo administered SC

Repeat doses of LY3885125 administered SC

Placebo administered SC

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Part A & B: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3885125
Part A & B: PK: AUC of LY3885125
Part A & B: PK: Maximum Observed Plasma Concentration (Cmax) of LY3885125
Part A & B: PK: Cmax of LY3885125
Part A & B: PK: Time of Maximum Observed Concentration (Tmax) of LY3885125
Part A & B: PK: Tmax of LY3885125
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
Part A & B: PD: Change From Baseline in apolipoprotein B (ApoB)
Part A & B: PD: Change From Baseline in ApoB
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

Full Information

First Posted
August 18, 2023
Last Updated
October 17, 2023
Sponsor
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT06007651
Brief Title
A Study of LY3885125 in Participants With Dyslipidemia or Non-Alcoholic Fatty Liver Disease (NAFLD)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2023 (Actual)
Primary Completion Date
April 15, 2025 (Anticipated)
Study Completion Date
April 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias, Non-Alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LY3885125 (Part A)
Arm Type
Experimental
Arm Description
Single ascending doses of LY3885125 administered subcutaneously (SC)
Arm Title
Placebo (Part A)
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC
Arm Title
LY3885125 (Part B)
Arm Type
Experimental
Arm Description
Repeat doses of LY3885125 administered SC
Arm Title
Placebo (Part B)
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC
Intervention Type
Drug
Intervention Name(s)
LY3885125
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
Baseline up to 49 weeks (Part A)
Title
Part B: Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration
Description
Part B: A summary of SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module
Time Frame
Baseline up to 62 weeks (Part B)
Secondary Outcome Measure Information:
Title
Part A & B: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3885125
Description
Part A & B: PK: AUC of LY3885125
Time Frame
Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)
Title
Part A & B: PK: Maximum Observed Plasma Concentration (Cmax) of LY3885125
Description
Part A & B: PK: Cmax of LY3885125
Time Frame
Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)
Title
Part A & B: PK: Time of Maximum Observed Concentration (Tmax) of LY3885125
Description
Part A & B: PK: Tmax of LY3885125
Time Frame
Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)
Title
Part A & B: Pharmacodynamics (PD): Change From Baseline in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9)
Description
Part A & B: PD: Change From Baseline in PCSK9
Time Frame
Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)
Title
Part A & B: PD: Change From Baseline in apolipoprotein B (ApoB)
Description
Part A & B: PD: Change From Baseline in ApoB
Time Frame
Baseline up to 49 weeks (Part A) and Baseline up to 62 weeks (Part B)
Title
Part B only: PD: Change of Liver Fat Content From Baseline by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)
Description
Part B only: PD: Change of Liver Fat Content From Baseline by MRI-PDFF
Time Frame
Baseline up to 62 weeks (Part B)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@Lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Worldwide Clinical Trials, Early Phase Services LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
210-635-1500
First Name & Middle Initial & Last Name & Degree
Alan Hand, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs