DyslipidemiasPhase 1NCT06007651
A Study of LY3885125 in Participants With Dyslipidemia or Non-Alcoholic Fatty Liver Disease (NAFLD)
A Phase 1 study testing LY3885125 in people with Dyslipidemias and Non-Alcoholic Fatty Liver Disease, run by Eli Lilly and Company at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dyslipidemias, Non-Alcoholic Fatty Liver Disease
- What is being tested?
- LY3885125
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2023to 12 Feb 2025
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Worldwide Clinical Trials, Inc.
San Antonio, Texas, 78217
About this study
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
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
- Being tested
- LY3885125, Placebo
- Medical subject headings
- Dyslipidemias, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3885125Drug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3885125 (Part A) | Experimental | Single ascending doses of LY3885125 administered subcutaneously (SC) Receives: Drug: LY3885125 |
| Placebo (Part A) | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
| LY3885125 (Part B) | Experimental | Repeat doses of LY3885125 administered SC Receives: Drug: LY3885125 |
| Placebo (Part B) | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Part A: PK: AUC of LY3885125
Measured: Baseline up to 36 weeks (Part A)
Part A: PK: Maximum Observed Plasma Concentration (Cmax) of LY3885125
Part A: PK: Cmax of LY3885125
Measured: Baseline up to 36 weeks (Part A)
Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3885125
Part A: PK: Tmax of LY3885125
Measured: Baseline up to 36 weeks (Part A)
Part A: Pharmacodynamics (PD): Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Part A: PD: Change From Baseline in PCSK9
Measured: Baseline up to Day 169 (Part A)
Part A: PD: Change From Baseline in Apolipoprotein B (ApoB)
Part A: PD: Change From Baseline in ApoB
Measured: Baseline up to Day 169 (Part A)
Part B Only: PD: Change of Liver Fat Content From Baseline by MRI-PDFF
Part B Only: PD: Change of Liver Fat Content from Baseline by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)
Measured: Baseline up to 62 weeks (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start10 Aug 2023
- Primary completion12 Feb 2025
- Study completion12 Feb 2025
Why it stopped: Participants were not dosed in Part B as per the protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007651
- Sponsor's protocol ID
- 18769
- Other IDs
- J4N-MC-YFAA
- Status last verified
- Mar 2026
- First submitted
- 18 Aug 2023
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No