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| ID | Type | Description | Link |
|---|---|---|---|
| J4D-MC-EZFA | Other Identifier | Eli Lilly and Company |
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The study was terminated due to a change in risk/benefit ratio, which no longer favoured continued development.
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The main purpose of this study is to determine the tolerability and side effects related to LY3875383 given as a single injection under the skin to healthy participants and participants with elevated triglyceride (TG) levels.The study will also assess how fast LY3875383 gets into the blood stream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of either LY3875383 or placebo.The study will be conducted in four parts (A, B, C and D) and may last up to approximately 28 to 56 weeks including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3875383 (Part A) | Experimental | Single-ascending doses of LY3875383 administered subcutaneously (SC). |
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| LY3875383 (Part B) | Experimental | Single doses of LY3875383 administered SC. |
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| LY3875383 (Part C) | Experimental | Single doses of LY3875383 administered SC. |
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| LY3875383 (Part D) | Experimental | Single doses of LY3875383 administered SC. |
|
| Placebo (Part A) | Placebo Comparator | Placebo administered SC. |
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| Placebo (Part B) | Placebo Comparator | Placebo administered SC. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3875383 | Drug | Administered SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Week 53 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK):Area Under the Concentration Versus Time Curve (AUC) of LY3875383 | PK: AUC of LY3875383 | Predose up to Day 8 post dose |
| PK: Maximum Observed Concentration (Cmax) of LY3875383 |
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Inclusion Criteria:
All participants:
Healthy participants (Part A):
• Participants must be overtly healthy, as determined by medical evaluation.
For Part B:
• Participants must be first-generation Japanese, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
Hypertriglyceridemia participants (Parts C and D):
For Part C:
For Part D:
Exclusion Criteria:
All participants:
For Part C: Have active pancreatitis within the last 6 months
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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 |
|---|---|---|---|---|---|---|
| Lilly Centre for Clinical Pharmacology | Singapore | 138623 | Singapore |
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| Label | URL |
|---|---|
| A Study of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia | View source |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Placebo (Part C) | Placebo Comparator | Placebo administered SC. |
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| Placebo (Part D) | Placebo Comparator | Placebo administered SC. |
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| Placebo | Drug | Administered SC. |
|
PK: Cmax of LY3875383
| Predose up to Day 8 post dose |
| Part C and D only: Pharmacodynamics (PD): Percentage Change from Baseline in Fasting Triglyceride (TG) | Part C and D only: PD: Percentage Change from Baseline in Fasting TG | Baseline through up to Week 53 |
| Part D only: PD: Percentage Change from Baseline in Fasting Non-High-Density Lipoprotein Cholesterol (HDL-C) | Part D only: PD: Percentage Change from Baseline in Fasting non-HDL-C | Baseline through Week 53 |
| D009750 |
| Nutritional and Metabolic Diseases |