Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J3F-MC-EZCA | 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 is a 3-part study. In Parts A and B, the main purpose is to evaluate the safety and tolerability of the study drug known as LY3561774 in participants with dyslipidemia (high blood fat levels). How the body processes the study drug and the effect of the study drug on blood fat levels will also be investigated. Part C will mainly evaluate the safety and tolerability of LY3561774 as well as how the body processes the study drug in Japanese participants. The study may last up 52, 56 and 28 weeks for each participant in Parts A, B and C, respectively. There are up to 22, 26 and 16 visits in Parts A, B and C, respectively.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3561774 (Part A) | Experimental | Single ascending doses of LY3561774 administered subcutaneously (SC). |
|
| LY3561774 (Part B) | Experimental | Repeat doses of LY3561774 administered SC. |
|
| LY3561774 (Part C) | Experimental | Single doses of LY3561774 administered SC in Japanese Participants. |
|
| Placebo (Part A, B & C) | Placebo Comparator | Placebo administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3561774 | Drug | Administered 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 Week 53 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3561774 | PK: AUC[0-tlast] of LY3561774 | Predose through Day 8 |
| PK: Maximum Observed Drug Concentration (Cmax) of LY3561774 |
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 |
|---|---|---|---|---|---|---|
| Altasciences Clinical Los Angeles, Inc | Cypress | California | 90630 | United States | ||
| Collaborative Neuroscience Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40158211 | Derived | Ray KK, Linnebjerg H, Michael LF, Shen X, Ma X, Lim S, Zhen EY, Dudek H, Abrams M, Saxena U, Turanov A, Nicholls SJ, Ruotolo G. Effect of ANGPTL3 Inhibition With Solbinsiran in Preclinical and Early Human Studies. J Am Coll Cardiol. 2025 May 20;85(19):1803-1818. doi: 10.1016/j.jacc.2025.03.005. Epub 2025 Mar 30. |
| Label | URL |
|---|---|
| A Study of LY3561774 in Participants With Dyslipidemia | View source |
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
| Placebo | Drug | Administered SC. |
|
PK: Cmax of LY3561774 |
| Predose through Day 8 |
| PK: Time of Maximum Observed Concentration (Tmax) of LY3561774 | PK: Tmax of LY3561774 | Predose through Day 8 |
| PD: Change From Baseline in Fasting Triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C) | PD: Change From Baseline in Fasting TG and LDL-C | Predose through Week 53 |
| Long Beach |
| California |
| 90806 |
| United States |
| Qps-Mra, Llc | South Miami | Florida | 33143 | United States |
| Hassman Research Institute | Marlton | New Jersey | 08053 | United States |
| Alliance for Multispecialty Research, LLC | Knoxville | Tennessee | 37920 | United States |