← Back to Search

Monoclonal Antibodies

LY3885125 for Non-Alcoholic Fatty Liver Disease/Dyslipidemia

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

Males, or females not of childbearing potential

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 49 weeks (part a) and baseline up to 62 weeks (part b)

Awards & highlights

Study Summary

This trial will test a new drug's safety and tolerance for people with dyslipidemia or fatty liver disease. Blood tests will monitor drug levels and elimination. Trial length: 111 weeks.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

While not specified here, common side effects may include reactions at the injection site, gastrointestinal issues like nausea or diarrhea, potential liver enzyme elevations, fatigue, headache or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a male or a female who cannot become pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 49 weeks (part a) and baseline up to 62 weeks (part b)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 49 weeks (part a) and baseline up to 62 weeks (part b)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 49 weeks (part a) and baseline up to 62 weeks (part b) 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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Part B: Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration

Secondary outcome measures

Part A & B: PD: Change From Baseline in apolipoprotein B (ApoB)

Part A & B: PK: Maximum Observed Plasma Concentration (Cmax) of LY3885125

Part A & B: PK: Time of Maximum Observed Concentration (Tmax) of LY3885125

+3 more

Trial Design

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,620 Previous Clinical Trials

3,216,487 Total Patients Enrolled

3 Trials studying Non-alcoholic Fatty Liver Disease

465 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Study DirectorEli Lilly and Company

1,348 Previous Clinical Trials

415,633 Total Patients Enrolled

2 Trials studying Non-alcoholic Fatty Liver Disease

372 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Frequently Asked Questions

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

Is it possible for me to participate in this research project?

"To participate in this medical trial, individuals who have dyslipidemia and are between 18 to 70 years old can submit an application. A total of 112 people will be accepted into the study."

Answered by AI

Does this clinical trial encompass participants of all ages, including those over thirty?

"This particular medical trial seeks patients that are aged 18 to 70. For those under the age of 18, there exists 35 studies and for people over 65, 404 clinical trials are available."

Answered by AI

Does LY3885125 (Part A) present any safety concerns for those undergoing treatment?

"Our team at Power has awarded LY3885125 (Part A) a safety rating of 1, as the clinical data regarding this medication is still in its infancy."

Answered by AI

Are researchers still recruiting participants for this medical experiment?

"Per the data hosted on clinicaltrials.gov, this research is still actively seeking candidates; it was first listed on August 10th 2023 and its most recent update occurred 8 days later."

Answered by AI

How many participants are being included in this experiment?

"Affirmative. According to the information presented on clinicaltrials.gov, this medical study is actively recruiting subjects, having been initially posted on August 10th 2023 and last updated August 18th 2023. The goal of the trial is to find 112 participants at a single site."

Answered by AI

What is the ultimate outcome of this research project?

"The primary outcome measure of the Eli Lilly and Company clinical trial will be the counting of participants with one or more serious adverse events related to drug administration. This is assessed over a period between baseline and 49 weeks (Part A). Secondary endpoints include maximum observed plasma concentration (Cmax) of LY3885125, time at which Cmax was recorded (Tmax), as well as changes from baseline in proprotein convertase subtilisin/Kexin type 9 levels (PCSK9)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of LY3885125 in Participants With Dyslipidemia or Non-Alcoholic Fatty Liver Disease (NAFLD)

2023. "A Study of LY3885125 in Participants With Dyslipidemia or Non-Alcoholic Fatty Liver Disease (NAFLD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06007651.

All > Nafld