RECRUITING

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

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH)Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)Hepatic fibrosis Biomarkers Magnetic resonance imaging Pharmacokinetics Liver fat

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3849891 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD) 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 MASLD and assessment of resolution of liver fibroinflammation. 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 visits in parts A and B.

Official Title

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

Quick Facts

Study Start:2022-06-08

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05395481

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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% 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) * 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 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 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

Inclusion Criteria

Exclusion 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% 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)
* 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 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 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

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559

clinical_inquiry_hub@lilly.com

Principal Investigator

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)

STUDY_DIRECTOR

Eli Lilly and Company

Study Locations (Sites)

Arizona Liver Health - Chandler

Chandler, Arizona, 85225

United States

Orange County Research Center

Orange, California, 92868

United States

Inland Empire Clinical Trials, LLC

Rialto, California, 92377

United States

Synergy Healthcare LLC

Brandon, Florida, 33511

United States

Accel Research Sites - Maitland

Maitland, Florida, 32751

United States

Floridian Clinical Research

Miami, Florida, 33016

United States

Evolution Clinical Trials, Inc

Miami, Florida, 33122

United States

Advanced Pharma Clinical Research

Miami, Florida, 33175

United States

Charter Research - Winter Park

Orlando, Florida, 32803

United States

IU Health University Hospital

Indianapolis, Indiana, 46290

United States

Houston Research Institute

Houston, Texas, 77079

United States

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229

United States

Pinnacle Clinical Research

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-08

Study Completion Date2026-10

Study Record Updates

Study Start Date2022-06-08

Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

Hepatic fibrosis
Biomarkers
Magnetic resonance imaging
Pharmacokinetics
Liver fat

Additional Relevant MeSH Terms

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