A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Nonalcoholic Fatty Liver Disease
N
Niharika Samala, MD
Primary Investigator
Not Recruiting
18 years - 70 years
All
Phase
1
176 participants needed
1 Location
Brief description of study
The main purpose of this study is to evaluate the safety and tolerability of the study drug
LY3849891 in participants with nonalcoholic fatty liver disease who have the patatin-likehospholipase domain-containing protein 3 (PNPLA3) I148M genotype. Blood tests and magneticging of the liver will be performed to determine the effects of LY3849891 ony liver disease. 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 mayude 12 and 13 visits in parts A and B, respectively.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Non-Alcoholic Fatty Liver Disease
-
Age: 18 years - 70 years
-
Gender: All
Inclusion Criteria:
- Participants must have a body mass index (BMI) within the range greater than or equal(≥) 25 and less than (<) 50 kilogram per square meter (kg/m²) inclusive
- Participants must have liver fat content ≥10% as determined by MRI-PDFF
- Participants must be carriers of the PNPLA3 I148M allele
- Participants with or without type 2 diabetes mellitus (T2DM)
- For participants with T2DM, hemoglobin A1c (HbA1c) <8%
- Male participants agree to use an effective method of contraception for the duration
of the study
- Women not of childbearing potential may participate and include those who are:due to surgical sterilization (hysterectomy, bilateral oophorectomy, orubal ligation), congenital anomaly such as Mullerian agenesis; or those who areusal
Exclusion Criteria:
- Participants must not have known or suspected alcohol abuse (>14 units/week for womend >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 congestiveheart 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 milliters/minute/1.73m²
- Participants must not have a diagnosis of type 1 diabetes
- Participants must not have a contraindication to MRI examinations, such as personswith cardiac pacemaker and implants made out of metal (for example, cochlear implant,ve stimulators, magnetic vascular clips, and metallic heart valve) or otherdications for MRI
Updated on
01 Aug 2024.
Study ID: GI-LILLY-J3W-MC-GZOA, 15594
