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LY3849891 for Non-alcoholic Fatty Liver Disease

Phase 1
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be carriers of the PNPLA3 I148M allele
For participants with T2DM, hemoglobin A1c (HbA1c) <8%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose through week 26
Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective for people with nonalcoholic fatty liver disease who have a certain genetic marker. There will be blood tests and MRIs to track the progress of the disease and how the body processes the drug.

Who is the study for?
This trial is for adults with nonalcoholic fatty liver disease who are overweight or obese, may or may not have type 2 diabetes (with HbA1c <8%), and carry the PNPLA3 I148M gene variant. Women must be non-childbearing due to surgery or menopause. Participants should not have a history of significant alcohol/substance abuse, active cancer in the last 5 years, uncontrolled high blood pressure, severe kidney issues, type 1 diabetes, MRI contraindications like metal implants, or serious heart conditions.Check my eligibility
What is being tested?
The study tests LY3849891's safety and effects on liver fat in participants with a specific genetic background related to fatty liver disease. It involves two parts: one where doses increase to find safe levels and another where repeated doses are given over up to 32 weeks. Effects will be measured using blood tests and MRI scans of the liver.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones from similar trials include gastrointestinal discomforts such as nausea or diarrhea; potential allergic reactions; headaches; fatigue; and possible impacts on liver enzymes which will be monitored through regular blood testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I carry the PNPLA3 I148M gene variant.
Select...
My latest HbA1c level is below 8%.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose through week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose through week 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Part B: Pharmacodynamics (PD): Relative change from baseline on liver fat content measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Secondary outcome measures
Part A & B: PD: Liver fat content at baseline and specified timepoints measured by MRI-PDFF
Part A & B: PK: Time to Maximum Observed Concentration (Tmax) of LY3849891
Part A & B: Part A & B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3849891
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3849891 (Part B)Experimental Treatment1 Intervention
Repeated doses of LY3849891 administered SC.
Group II: LY3849891 (Part A)Experimental Treatment1 Intervention
Single ascending doses of LY3849891 administered subcutaneously (SC).
Group III: Placebo (Part A)Placebo Group1 Intervention
Placebo administered SC.
Group IV: Placebo (Part B)Placebo Group1 Intervention
Placebo administered SC.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,605 Previous Clinical Trials
3,199,179 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
401 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Study DirectorEli Lilly and Company
1,338 Previous Clinical Trials
403,552 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
308 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

LY3849891 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05395481 — Phase 1
Non-alcoholic Fatty Liver Disease Research Study Groups: LY3849891 (Part A), LY3849891 (Part B), Placebo (Part A), Placebo (Part B)
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: LY3849891 Highlights & Side Effects. Trial Name: NCT05395481 — Phase 1
LY3849891 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05395481 — Phase 1
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT05395481 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor open to individuals older than 45?

"The enrollment requirements of this study restrict participants to those aged 18 or above, with a ceiling age limit of 70."

Answered by AI

Is LY3849891 a reliable option for health-conscious individuals?

"The safety of LY3849891 has been evaluated as a 1 on our Power scale, signifying that the drug is currently in Phase 1 trials and there is minimal data affirming its efficacy or safety."

Answered by AI

What is the overall count of participants in this experiment?

"To complete this clinical trial, 176 participants meeting the predetermined qualifications are needed. Participants can enroll at Inland Empire Clinical Trials, LLC in Rialto, California or Accel Research Sites - Maitland in Maitland, Texas."

Answered by AI

Is participation in this research currently available to the public?

"That is correct. Clinicaltrials.gov contains information indicating that this medical study, which was first publicized on June 8th 2022, is currently active and requires 176 individuals from 8 distinct sites."

Answered by AI

In what locations is this research initiative underway?

"Currently, 8 distinct medical sites are hosting this trial. The cities in question are Rialto, Maitland and San Antonio among other locations. To reduce the need to travel extensively, we suggest selecting a nearby clinic when signing up."

Answered by AI

What is the purpose of this clinical research?

"This clinical trial, spanning from predose to 26 weeks post dose, is designed to assess the relative change of liver fat content by magnetic resonance imaging proton density fat fraction (MRI-PDFF) as its primary objective. Secondary objectives include measuring maximum observed concentration and time to maximum observed concentration for LY3849891, in addition to assessing pre-existing levels of liver fat at various points within the study period."

Answered by AI

To whom is participation in this clinical experiment being offered?

"This clinical trial is open to 176 participants aged 18-70 who display symptoms of nonalcoholic steatohepatitis. Further eligibility requirements demand that these prospective patients have a BMI in the range 25<x<50kg/m², MRI-PDFF determined liver fat content ≥10%, be carriers of PNPLA3 I148M allele and (if applicable) have HbA1c <8%. Male candidates must also agree to use reliable contraception for the duration of this study, while women not able to conceive can still take part if they are surgically sterile or postmenopausal."

Answered by AI

Who else is applying?

What state do they live in?
California
Louisiana
Illinois
What site did they apply to?
Orange County Research Center
IU Health University Hospital
Clinical Trials of Texas, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I was surprised by my diagnosis so I want to avoid further deterioration and to improved my health.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Details of the study; what are the screening details and time requirements?
PatientReceived 1 prior treatment
~44 spots leftby Nov 2024