A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Launched by ELI LILLY AND COMPANY · May 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called LY3849891 to see if it is safe and how well it works for people with nonalcoholic fatty liver disease, particularly those who have a specific genetic variation known as PNPLA3 I148M. The trial will involve blood tests and MRI scans of the liver to check how the drug affects liver fat and how long it stays in the body. The study is split into two parts and could last up to 32 weeks, with participants needing to come in for 12 to 13 visits.

To be eligible for the study, participants should be adults aged between 18 and 75, have a body mass index (BMI) of 25 or higher, and show at least 10% liver fat on an MRI. They can have type 2 diabetes but need to have controlled blood sugar levels. However, people with a history of alcohol abuse, certain heart or kidney problems, or other specific medical conditions may not be able to participate. This study aims to help improve understanding and treatments for nonalcoholic fatty liver disease, which can often go unnoticed but may lead to serious health issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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