A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Nonalcoholic Fatty Liver Disease

JRCT ID: jRCT2031220200

Registered date:08/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-Alcoholic Fatty Liver Disease
• Date of first enrollment: 06/07/2022
• Target sample size: 176
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

Drug: LY3849891
Administered SC.
Drug: Placebo
Administered SC.
Study Arms
-Experimental: LY3849891 (Part A)
Single ascending doses of LY3849891 administered subcutaneously (SC).
Intervention: Drug: LY3849891
-Experimental: LY3849891 (Part B)
Repeated doses of LY3849891 administered SC.
Intervention: Drug: LY3849891
-Placebo Comparator: Placebo (Part A)
Placebo administered SC.
Intervention: Drug: Placebo
-Placebo Comparator: Placebo (Part B)
Placebo administered SC.
Intervention: Drug: Placebo

Outcome(s)

Primary Outcome

Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Predose up to 26 weeks post dose ]
A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
Part B: Pharmacodynamics (PD): Relative change from baseline on liver fat content measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF) [ Time Frame: Baseline through 12 weeks ]
PD: Relative change from baseline on liver fat content measured by MRI-PDFF

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 70age old
• Gender: Both

Include 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% 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: infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or those who are postmenopausal

Exclude 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 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 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

Related Information

• Primary Sponsor: Wakayama Naohiko
• Secondary ID(s): NCT05395481