LY3885125 for Non-Alcoholic Fatty Liver Disease/Dyslipidemia

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Eli Lilly and Company

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called LY3885125 to see if it is safe and well-tolerated. It involves people with dyslipidemia and non-alcoholic fatty liver disease. Researchers will measure how much of the drug gets into the blood and how long it stays there.

Research Team

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)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for adults with dyslipidemia or NAFLD who've been on a stable diet. For dyslipidemia, they need certain blood levels and a BMI of 18.5-45 kg/m2; for NAFLD, liver fat ≥8% by MRI and BMI of 27-45 kg/m2. Exclusions include uncontrolled high blood pressure, recent weight changes >5kg, specific medication use, and other chronic diseases.

Inclusion Criteria

I have NAFLD with liver fat ≥8% and my BMI is between 27 and 45.

I have dyslipidemia and my BMI is between 18.5 and 45.0.

On a stable diet for the 3 months prior to randomization and willing to continue the same stable diet during the study

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Exclusion Criteria

I have taken medication linked to fatty liver disease for over 2 weeks in the last 3 months.

I haven't taken certain medications in the last 9 months.

I haven't started or changed any medication that affects my weight significantly in the last 3 months.

See 9 more

Treatment Details

Interventions

LY3885125 (Monoclonal Antibodies)

Trial OverviewThe study tests LY3885125's safety in single (part A) and multiple doses (part B) against a placebo in people with dyslipidemia or NAFLD. It measures how the body absorbs and eliminates the drug over roughly 49 weeks for part A and up to 62 weeks for part B.

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3885125 (Part B)Experimental Treatment1 Intervention

Repeat doses of LY3885125 administered SC

Group II: LY3885125 (Part A)Experimental Treatment1 Intervention

Single ascending doses of LY3885125 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