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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 (J3W-MC-GZOA)

A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (J3W-MC-GZOA)

Wakayama Naohiko

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Complete

July. 12, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-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)
-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

-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

Both

Metabolic Dysfunction-Associated Steatohepatitis / Steatotic Liver Disease (MASH) (MASLD)

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

Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs and AEs, regardless of causality, will be reported in the Reported Adverse Events module
[Time Frame: Predose up to 26 weeks post dose]

Part B: Pharmacodynamics (PD): Mean change from baseline on liver inflammation and fibrosis measured by magnetic resonance imaging (MRI)
PD:Mean change from baseline on liver inflammation and fibrosis content measured by MRI
[Time Frame: Baseline through 24 weeks]

+81-42-625-5216

May. 10, 2022

No

United States