Phase
Condition
Primary Biliary Cholangitis
Liver Disease
Treatment
Placebo
LY3849891
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must have a body mass index (BMI) within the range greater than orequal 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 asdetermined 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 durationof 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, ortubal ligation), congenital anomaly such as Mullerian agenesis; or those who arepostmenopausal
Exclusion
Exclusion Criteria:
Participants must not have known or suspected alcohol abuse (>14 units/week forwomen 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 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 filtrationrate (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 personswith cardiac pacemaker and implants made out of metal (for example, cochlearimplant, nerve stimulators, magnetic vascular clips, and metallic heart valve) orother contraindications for MRI
Study Design
Connect with a study center
P-One Clinic
Hachioji, Tokyo 192-0071
JapanActive - Recruiting
Clinical Research Hospital Tokyo
Shinjuku-ku, Tokyo 160-0004
JapanActive - Recruiting
FDI Clinical Research
San Juan, 00927
Puerto RicoSite Not Available
Arizona Liver Health - Chandler
Chandler, Arizona 85225
United StatesSite Not Available
Orange County Research Center
Orange, California 92868
United StatesActive - Recruiting
Inland Empire Clinical Trials, LLC
Rialto, California 92377
United StatesSite Not Available
Orange County Research Center
Tustin, California 92780
United StatesSite Not Available
Synergy Healthcare LLC
Brandon, Florida 33511
United StatesSite Not Available
Accel Research Sites - Maitland
Maitland, Florida 32751
United StatesActive - Recruiting
Advanced Pharma Clinical Research
Miami, Florida 33175
United StatesActive - Recruiting
Evolution Clinical Trials, Inc
Miami, Florida 33122
United StatesSite Not Available
Floridian Clinical Research
Miami, Florida 33016
United StatesActive - Recruiting
Charter Research - Winter Park
Orlando, Florida 32803
United StatesSite Not Available
IU Health University Hospital
Indianapolis, Indiana 46290
United StatesActive - Recruiting
Houston Research Institute
Houston, Texas 77079
United StatesSite Not Available
Clinical Trials of Texas, Inc.
San Antonio, Texas 78229
United StatesActive - Recruiting
Pinnacle Clinical Research
San Antonio, Texas 78229
United StatesActive - Recruiting
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