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

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ClinicalTrials.gov Identifier: NCT05395481
Recruitment Status : Recruiting
First Posted : May 27, 2022
Last Update Posted : March 15, 2024
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
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-like phospholipase domain-containing protein 3 (PNPLA3) I148M genotype. Blood tests and magnetic resonance imaging of the liver will be performed to determine the effects of LY3849891 on fatty 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 may include 12 and 13 visits in parts A and B, respectively.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Drug: LY3849891 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Single-Ascending and Repeated Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3849891 in Participants With Nonalcoholic Fatty Liver Disease Who Have the PNPLA3 I148M Genotype
Actual Study Start Date : June 8, 2022
Estimated Primary Completion Date : November 5, 2024
Estimated Study Completion Date : November 5, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3849891 (Part A)
Single ascending doses of LY3849891 administered subcutaneously (SC).
 Drug: LY3849891
Administered SC.
Experimental: LY3849891 (Part B)
Repeated doses of LY3849891 administered SC.
 Drug: LY3849891
Administered SC.
Placebo Comparator: Placebo (Part A)
Placebo administered SC.
 Drug: Placebo
Administered SC.
Placebo Comparator: Placebo (Part B)
Placebo administered SC.
 Drug: Placebo
Administered SC.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Part A & B: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3849891 [ Time Frame: Predose through Week 26 ]
    Part A & B: PK: Cmax of LY3849891

  2. Part A & B: Part A & B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3849891 [ Time Frame: Predose through Week 26 ]
    Part A & B: PK: AUC of LY3849891

  3. Part A & B: PK: Time to Maximum Observed Concentration (Tmax) of LY3849891 [ Time Frame: Predose through Week 26 ]
    Part A & B: PK: Tmax of LY3849891

  4. Part A & B: PD: Liver fat content at baseline and specified timepoints measured by MRI-PDFF [ Time Frame: Predose through Week 26 ]
    Part A & B: PD: Liver fat content at baseline and specified timepoints measured by MRI-PDFF

  5. Part B: PD: Alanine aminotransferase (ALT) measurements at baseline and specified time points [ Time Frame: Predose through Week 26 ]
    Part B: PD: ALT measurements at baseline and specified time points


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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% 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%

  • 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

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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05395481


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@Lilly.com

Locations
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United States, California
Inland Empire Clinical Trials, LLC Recruiting
Rialto, California, United States, 92377
Principal Investigator: Zeid Kayali         
Orange County Research Center Recruiting
Tustin, California, United States, 92780
Contact    714-550-9990      
Principal Investigator: JOEL MICHAEL NEUTEL         
United States, Florida
Accel Research Sites - Maitland Recruiting
Maitland, Florida, United States, 32751
Contact    407-644-1165      
Principal Investigator: Eva Maria Heurich         
Floridian Clinical Research Recruiting
Miami, Florida, United States, 33016
Contact    305-330-9977      
Principal Investigator: William Eduardo Sanchez         
Advanced Pharma Clinical Research Recruiting
Miami, Florida, United States, 33147-4040
Principal Investigator: Kimberly Cruz         
United States, Indiana
IU Health University Hospital Recruiting
Indianapolis, Indiana, United States, 46290
Contact    317-274-3264      
Principal Investigator: Niharika Samala         
United States, Texas
Clinical Trials of Texas, Inc. Recruiting
San Antonio, Texas, United States, 78229
Contact    210-949-0122      
Principal Investigator: Douglas Scott Denham         
Pinnacle Clinical Research Recruiting
San Antonio, Texas, United States, 78229
Contact    210-982-0320      
Principal Investigator: Madhavi Rudraraju         
Japan
P-One Clinic Recruiting
Hachioji, Tokyo, Japan, 192-0071
Principal Investigator: Kenichi Furihata         
Clinical Research Hospital Tokyo Recruiting
Shinjuku-ku, Tokyo, Japan, 160-0004
Principal Investigator: Hiroyuki Fukase         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05395481    
Other Study ID Numbers: 18214
J3W-MC-GZOA ( Other Identifier: Eli Lilly and Company )
First Posted: May 27, 2022    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Non-alcoholic steatohepatitis
Hepatic fibrosis
Biomarkers
 Magnetic resonance imaging
Pharmacokinetics
Liver fat
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases