NCT05395481CompletedPhase 1
A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A Single-Ascending and Repeated Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) Who Have the PNPLA3 I148M Genotype
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 115 (actual)
- First submitted
- 24 May 2022
- Start date
- 8 Jun 2022
- Primary completion date
- 12 May 2026
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05395481
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 115
- From 8 Jun 2022 to the primary completion date, 12 May 2026
- 16 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants must not have evidence of cirrhosis or other forms of liver disease
- Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 3 months
- Participants must not have active cancer within the last 5 years
- Participants must not have a diagnosis of type 1 diabetes
- Participants must not have a contraindication to MRI examinations, such as persons with cardiac pacemaker and implants made out of metal (for example, cochlear implant, nerve stimulators, magnetic vascular clips, and metallic heart valve) or other contraindications for MRI
Lab values
- Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) \<60 milliliter per minute per 1.73 square meter (ml/min/1.73m²)
Other
- Participants must not have known or suspected alcohol abuse (\>14 units/week for women and \>21 units/week for men) or active substance abuse
- Participants must not have uncontrolled high blood pressure
Who the study is looking for
- Participants must have a body mass index (BMI) within the range greater than or equal to (≥) 25 and less than (\<) 50 kilogram per square meter (kg/m²) inclusive
- Participants must have liver fat content ≥10% in Part A and ≥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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| P-One Clinic Coordinator of this site? Confirm its status | Hachiōji | Japan | Unknown status |
| Clinical Research Hospital Tokyo Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| FDI Clinical Research Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Synergy Healthcare LLC Coordinator of this site? Confirm its status | Brandon | United States | Unknown status |
| Arizona Liver Health - Chandler Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| Houston Research Institute Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| IU Health University Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Accel Research Sites - Maitland Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| Evolution Clinical Trials, Inc Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Advanced Pharma Clinical Research Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Floridian Clinical Research Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Orange County Research Center Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Charter Research - Winter Park Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Inland Empire Clinical Trials, LLC Coordinator of this site? Confirm its status | Rialto | United States | Unknown status |
| Pinnacle Clinical Research Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Clinical Trials of Texas Inc Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.