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| ID | Type | Description | Link |
|---|---|---|---|
| J4N-MC-YFAA | Other Identifier | Eli Lilly and Company |
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Participants were not dosed in Part B as per the protocol.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3885125 (Part A) | Experimental | Single ascending doses of LY3885125 administered subcutaneously (SC) |
|
| Placebo (Part A) | Placebo Comparator | Placebo administered SC |
|
| LY3885125 (Part B) | Experimental | Repeat doses of LY3885125 administered SC |
|
| Placebo (Part B) | Placebo Comparator | Placebo administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3885125 | Drug | Administered SC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3885125 | Part A: PK: AUC of LY3885125 | Baseline up to 36 weeks (Part A) |
| Part A: PK: Maximum Observed Plasma Concentration (Cmax) of LY3885125 |
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Inclusion Criteria:
Parts A & B
Part A
Exclusion Criteria:
Parts A & B
Part B
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worldwide Clinical Trials, Inc. | San Antonio | Texas | 78217 | United States |
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The study was planned to include Part A (single-ascending-dose [SAD]) and Part B (multiple-ascending-dose [MAD]). However, the study was terminated early and did not proceed to Part B; therefore, no participants were enrolled in Part B
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: SAD Cohort 1 | Part A: Participants received a single dose of 1st dose level of LY3885125 administered subcutaneously. |
| FG001 | Part A: SAD Cohort 2 | Part A: Participants received a single dose of 2nd dose level of LY3885125 administered subcutaneously. |
| FG002 | Part A: SAD Cohort 3 | Part A: Participants received a single dose of 3rd dose level of LY3885125 administered subcutaneously. |
| FG003 | Part A: SAD Cohort 4 | Part A: Participants received a single dose of 4th dose level of LY3885125 administered subcutaneously. |
| FG004 | Part A: SAD Cohort 5 | Part A: Participants received a single dose of 5th dose level of LY3885125 administered subcutaneously. |
| FG005 | Part A: Placebo | Part A: Placebo group |
| FG006 | Part B: MAD | Participants were planned to receive multiple ascending doses of LY3885125 administered subcutaneously |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The study was planned to include Part A (single-ascending-dose [SAD]) and Part B (multiple-ascending-dose [MAD]). However, the study was terminated early and did not proceed to Part B; therefore, no participants were enrolled in Part B.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: SAD Cohort 1 | Part A: Participants received a single dose of 1st dose level of LY3885125 administered subcutaneously. |
| BG001 | Part A: SAD Cohort 2 | Part A: Participants received a single dose of 2nd dose level of LY3885125 administered subcutaneously |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | All Participants aged 18 to 70 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Participants who were dosed were analyzed for adverse events. | Posted | Count of Participants | Participants | No | Baseline up to 36 weeks (Part A) |
|
Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention.
Participants who were dosed were analyzed for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: SAD Cohort 1 | Part A: Participants received a single dose of 1st dose level of LY3885125 administered subcutaneously. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eli Lilly | Eli Lilly and Company | 1-877-285-4559 | LillyTrials@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 21, 2023 | Feb 11, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 17, 2025 | Feb 11, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005234 | Fatty Liver |
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| Placebo |
| Drug |
Administered SC |
|
Part A: PK: Cmax of LY3885125
| Baseline up to 36 weeks (Part A) |
| Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3885125 | Part A: PK: 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) | Part A: PD: Change From Baseline in PCSK9 | 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 | 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) | Baseline up to 62 weeks (Part B) |
| Adverse Event |
|
| BG002 | Part A: SAD Cohort 3 | Part A: Participants received a single dose of 3rd dose level of LY3885125 administered subcutaneously. |
| BG003 | Part A: SAD Cohort 4 | Part A: Participants received a single dose of 4th dose level of LY3885125 administered subcutaneously. |
| BG004 | Part A: SAD Cohort 5 | Part A: Participants received a single dose of 5th dose level of LY3885125 administered subcutaneously. |
| BG005 | Part A: Placebo | Part A: Placebo group |
| BG006 | Part B: MAD | Part B: Participants were planned to receive multiple ascending doses of LY3885125 administered subcutaneously. |
| BG007 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race/ Ethnicity Count of Participants | Count of Participants | Participants |
|
| OG002 | Part A: SAD Cohort 3 | Part A: Participants received a single dose of 3rd dose level of LY3885125 administered subcutaneously. |
| OG003 | Part A: SAD Cohort 4 | Part A: Participants received a single dose of 4th dose level of LY3885125 administered subcutaneously. |
| OG004 | Part A: SAD Cohort 5 | Part A: Participants received a single dose of 5th dose level of LY3885125 administered subcutaneously. |
| OG005 | Part A: Placebo | Part A: Placebo group |
|
|
| 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 | The study was terminated early and did not proceed to Part B; therefore, no participants were enrolled, and zero participants were analyzed. | Posted | Baseline up to 36 weeks (Part B) |
|
|
| Secondary | Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3885125 | Part A: PK: AUC of LY3885125 | AUCinf | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Baseline up to 36 weeks (Part A) |
|
|
|
| Secondary | Part A: PK: Maximum Observed Plasma Concentration (Cmax) of LY3885125 | Part A: PK: Cmax of LY3885125 | Cmax | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Baseline up to 36 weeks (Part A) |
|
|
|
| Secondary | Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3885125 | Part A: PK: Tmax of LY3885125 | Tmax | Posted | Median | Full Range | hours | Baseline up to 36 weeks (Part A) |
|
|
|
| Secondary | Part A: Pharmacodynamics (PD): Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) | Part A: PD: Change From Baseline in PCSK9 | Change in Baseline to follow up visit day 169 | Posted | Median | Full Range | ng/mL | Baseline up to Day 169 (Part A) |
|
|
|
| Secondary | Part A: PD: Change From Baseline in Apolipoprotein B (ApoB) | Part A: PD: Change From Baseline in ApoB | Change from Baseline to Follow up Visit Day 169 | Posted | Median | Full Range | ng/mL | Baseline up to Day 169 (Part A) |
|
|
|
| Secondary | 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) | The study was terminated early and did not proceed to Part B; therefore, no participants were enrolled, and zero participants were analyzed. | Posted | Baseline up to 62 weeks (Part B) |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Part A: SAD Cohort 2 | Part A: Participants received a single dose of 2nd dose level of LY3885125 administered subcutaneously. | 0 | 4 | 0 | 4 | 3 | 4 |
| EG002 | Part A: SAD Cohort 3 | Part A: Participants received a single dose of 3rd dose level of LY3885125 administered subcutaneously. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG003 | Part A: SAD Cohort 4 | Part A: Participants received a single dose of 4th dose level of LY3885125 administered subcutaneously. | 0 | 9 | 0 | 9 | 6 | 9 |
| EG004 | Part A: SAD Cohort 5 | Part A: Participants received a single dose of 5th dose level of LY3885125 administered subcutaneously. | 0 | 10 | 0 | 10 | 4 | 10 |
| EG005 | Part A: Placebo | Part A: Participants received a single dose of placebo administered subcutaneously. | 0 | 10 | 0 | 10 | 5 | 10 |
| EG006 | Part B: MAD | Part B: Participants were planned to receive multiple ascending doses of LY3885125 administered subcutaneously. | 0 | 0 | 0 | 0 | 0 | 0 |
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| AST Increased | Investigations | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Injection Site Pain | General disorders | Systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
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| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |