Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J1T-MC-GZEA | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the safety and tolerability of LY3475766 when given to participants with high levels of blood fat called triglycerides. It will also investigate how the body processes the study drug and the effect of the study drug on the body. Information about any side effects will be documented. This study will last up to 16 weeks for each participant.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3475766 - IV | Experimental | LY3475766 administered intravenously (IV) to participants with dyslipidemia |
|
| Placebo - IV | Placebo Comparator | Placebo administered IV to participants with dyslipidemia |
|
| LY3475766 - SC | Experimental | LY3475766 administered subcutaneously (SC) to participants with dyslipidemia |
|
| Placebo - SC | Placebo Comparator | Placebo administered SC to participants with dyslipidemia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3475766 - IV | Drug | Administered IV |
| |
| LY3475766 - SC |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 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 Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3475766 | PK: AUC of LY3475766 | Predose up to Day 85 |
| PK: Maximum Observed Drug Concentration (Cmax) of LY3475766 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|---|
| WCCT Global | Cypress | California | 90630 | United States | ||
| Covance Clinical Research Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40640392 | Derived | Gaudet D, Gonciarz M, Shen X, Leohr JK, Beyer TP, Day JW, Mullins GR, Zhen EY, Hartley M, Larouche M, Konrad RJ, Benichou O, Ruotolo G. Targeting the angiopoietin-like protein 3/8 complex with a monoclonal antibody in patients with mixed hyperlipidemia: a phase 1 trial. Nat Med. 2025 Aug;31(8):2632-2639. doi: 10.1038/s41591-025-03830-4. Epub 2025 Jul 10. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Administered SC |
|
| Placebo - IV | Drug | Administered IV |
|
| Placebo - SC | Drug | Administered SC |
|
PK: Cmax of LY3475766
| Predose up to Day 85 |
| PK: Time to Maximum Observed Drug Concentration (Tmax) of LY3475766 | PK: Tmax of LY3475766 | Predose up to Day 85 |
| Pharmacodynamics (PD): Percent Change from Baseline in Triglycerides (TG) | PD: Percent Change from Baseline in TG | Baseline, Day 85 |
| PD: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) | PD: Percent Change from Baseline in LDL-C | Baseline, Day 85 |
| PD: Percent Change from Baseline in Apolipoprotein B (ApoB) | PD: Percent Change from Baseline in ApoB | Baseline, Day 85 |
| Daytona Beach |
| Florida |
| 32117 |
| United States |
| Covance Dallas | Dallas | Texas | 75247 | United States |
| Covance Clinical Research Inc | Madison | Wisconsin | 53704 | United States |