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LY3849891 for Non-alcoholic Fatty Liver Disease
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I do not have any implants or conditions that prevent me from having an MRI.I carry the PNPLA3 I148M gene variant.I have not had active cancer in the last 5 years.People with or without type 2 diabetes.I do not have type 1 diabetes.My latest HbA1c level is below 8%.I haven't had a heart attack, stroke, or been hospitalized for heart failure recently.My blood pressure is under control.I am a woman who cannot become pregnant due to surgery, a birth condition, or being postmenopausal.My kidney function is normal or only mildly reduced.My liver is healthy without any signs of cirrhosis or disease.I agree to use effective birth control during the study.People with or without type 2 diabetes are eligible to participate.
- Group 1: LY3849891 (Part A)
- Group 2: LY3849891 (Part B)
- Group 3: Placebo (Part A)
- Group 4: Placebo (Part B)
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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How many prior treatments have patients received?
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