Status:
RECRUITING
A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 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 uncontrolled high blood pressure
- 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)
- 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
Key Trial Info
Start Date :
June 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT05395481
Start Date
June 8 2022
End Date
October 1 2026
Last Update
December 9 2025
Active Locations (16)
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1
Arizona Liver Health - Chandler
Chandler, Arizona, United States, 85225
2
Orange County Research Center
Orange, California, United States, 92868
3
Inland Empire Clinical Trials, LLC
Rialto, California, United States, 92377
4
Synergy Healthcare LLC
Brandon, Florida, United States, 33511