Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J3W-MC-GZOA | 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
The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3849891 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD) who have the patatin-like phospholipase domain-containing protein 3 (PNPLA3) I148M genotype. Blood tests and magnetic resonance imaging of the liver will be performed to determine the effects of LY3849891 on MASLD and assessment of resolution of liver fibroinflammation. Blood tests will also determine how long it takes the body to eliminate LY3849891. This is a 2-part study and may last up to 32 weeks for each participant and may include 12 visits in parts A and B.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3849891 (Part A) | Experimental | Single ascending doses of LY3849891 administered subcutaneously (SC) |
|
| LY3849891 (Part B) | Experimental | Repeated doses of LY3849891 administered SC |
|
| Placebo (Part A) | Placebo Comparator | Placebo administered SC |
|
| Placebo (Part B) | Placebo Comparator | Placebo administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3849891 | Drug | Administered SC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of TEAEs and AEs, regardless of causality, will be reported in the Reported Adverse Events module | Predose up to 26 weeks post dose |
| Part B: Pharmacodynamics (PD): Mean change from baseline on liver inflammation and fibrosis measured by magnetic resonance imaging (MRI) | PD: Mean change from baseline on liver inflammation and fibrosis content measured by MRI | Baseline through 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: PD: Liver fat content measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF) | Part A: PD: Liver fat content measured by (MRI-PDFF) | Predose through Week 26 |
| Part A: PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC(0-inf)) of LY3849891 |
Not provided
Inclusion Criteria:
Participants must have a body mass index (BMI) within the range greater than or equal to (â„) 25 and less than (<) 50 kilogram per square meter (kg/mÂČ) inclusive
Participants must have liver fat content â„10% in Part A and â„8% for Part B as determined by MRI-PDFF
Participants must be carriers of the PNPLA3 I148M allele
Participants with or without type 2 diabetes mellitus (T2DM)
o For participants with T2DM, hemoglobin A1c (HbA1c) <8% in Part A and <9% in Part B
Male participants agree to use an effective method of contraception for the duration of the study and for 90 days after the last dose of study intervention
Women not of childbearing potential may participate and include those who are: infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or those who are postmenopausal
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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Liver Health - Chandler | Chandler | Arizona | 85225 | United States | ||
| Orange County Research Center |
Not provided
| Label | URL |
|---|---|
| A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Nonalcoholic Fatty Liver Disease | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Administered SC |
|
Part A: PK: AUC(0-inf) of LY3849891 |
| Predose through Week 26 |
| Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3849891 | Part A: PK: Cmax of LY3849891 | Predose through Week 26 |
| Part A: PK: Time to Maximum Observed Concentration (Tmax) of LY3849891 | Part A: PK: Tmax of LY3849891 | Predose through Week 26 |
| Part B: PD: Liver fat content changes at baseline and specified timepoints by MRI-PDFF | Part B: PD: Liver fat content changes at baseline and specified timepoints by MRI-PDFF | Predose through Week 24 |
| Part B: PK: AUC(0-inf) of LY3849891 and its Metabolite | Part B: PK: AUC(0-inf) of LY3849891 and its metabolite | Predose through Week 24 |
| Part B: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3849891 and its metabolite | Part B: PK: Cmax of LY3849891 and its metabolite | Predose through Week 24 |
| Part B: PK: Tmax of LY3849891 and its metabolite | Part B: PK: Tmax of LY3849891 and its metabolite | Predose through Week 24 |
| Orange |
| California |
| 92868 |
| United States |
| Inland Empire Clinical Trials, LLC | Rialto | California | 92377 | United States |
| Synergy Healthcare LLC | Brandon | Florida | 33511 | United States |
| Accel Research Sites - Maitland | Maitland | Florida | 32751 | United States |
| Evolution Clinical Trials, Inc | Miami | Florida | 33122 | United States |
| Advanced Pharma Clinical Research | Miami | Florida | 33175 | United States |
| Floridian Clinical Research | Miami Lakes | Florida | 33016 | United States |
| Charter Research - Winter Park | Orlando | Florida | 32803 | United States |
| IU Health University Hospital | Indianapolis | Indiana | 46290 | United States |
| Houston Research Institute | Houston | Texas | 77079 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Pinnacle Clinical Research | San Antonio | Texas | 78229 | United States |
| P-One Clinic | HachiĆji | 192-0071 | Japan |
| Clinical Research Hospital Tokyo | Shinjuku-ku | 160-0004 | Japan |
| FDI Clinical Research | San Juan | 00927 | Puerto Rico |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided