LY3561774 for Dyslipidemia

No longer recruiting at 5 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Triglyceride-lowering drugs

Disqualifiers: Type 1 diabetes, Heavy alcohol, others

Compensation: Varies

Number of Visits: 64

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY3561774 for individuals with dyslipidemia, a condition characterized by high levels of fat in the blood. The main goals are to determine the safety of LY3561774 and its effects on blood fat levels. The trial consists of three parts, with some participants receiving the actual treatment and others receiving a placebo (a harmless pill or shot with no active effect). Candidates may qualify if they have high triglycerides and cholesterol levels and have not taken medication to lower these fats in the past two months. Part C specifically focuses on participants of first-generation Japanese origin. As a Phase 1 trial, participants could be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

Will I have to stop taking my current medications?

If you are taking prescription medications to lower triglycerides, you must stop them at least 2 months before joining the trial. However, you can continue taking statins if your dose has been stable for 8 weeks.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LY3561774 has been tested for safety in people with high levels of fat in their blood, known as dyslipidemia. One study reported serious side effects in 20 cases, about 0.36% of participants. Importantly, no deaths or life-threatening incidents occurred, suggesting the treatment is generally safe. Most side effects were mild and similar to those experienced by people who received a placebo (a substance with no active drug). Additionally, scans after treatment showed no harmful effects on the liver. While side effects can occur, the data indicates that LY3561774 is usually well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for dyslipidemia, which often include statins that work by inhibiting cholesterol production in the liver, LY3561774 offers a fresh approach. Researchers are excited about LY3561774 because it is administered subcutaneously, which could improve patient compliance compared to daily oral medications. Additionally, it involves single or repeat dosing, which might offer flexibility and convenience for patients. This novel treatment could potentially provide a more tailored approach to managing lipid levels, especially for those who have not responded well to traditional therapies.

What evidence suggests that LY3561774 could be an effective treatment for dyslipidemia?

Research has shown that LY3561774, which participants in this trial may receive, is under investigation for managing dyslipidemia, a condition characterized by high levels of fats in the blood. Early findings suggest that this treatment might help lower these fat levels. Although detailed results from ongoing studies are not fully available yet, LY3561774 targets specific pathways in the body to reduce harmful fats. This could help manage cholesterol and triglycerides, important factors in dyslipidemia. Early research in similar studies has shown promising results in reducing these blood fats, indicating its potential effectiveness. ^{1 2 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

Inclusion Criteria

Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²)

For Parts A and B, have a fasting triglyceride (TG) level greater than or equal to (≥) 150 milligram/deciliter (mg/dL) and less than 500 mg/dL, as well as low density lipoprotein cholesterol (LDL-C) level greater than or equal to (≥) 70 mg/dL

For Part C, participants should be first-generation Japanese origin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Single ascending doses of LY3561774 administered subcutaneously

52 weeks

Up to 22 visits

Treatment Part B

Repeat doses of LY3561774 administered subcutaneously

56 weeks

Up to 26 visits

Treatment Part C

Single doses of LY3561774 administered subcutaneously in Japanese participants

28 weeks

Up to 16 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3561774
• Placebo

How Is the Trial Designed?

Group I: LY3561774 (Part C) Experimental Treatment 1 Intervention

Single doses of LY3561774 administered SC in Japanese Participants.

Group II: LY3561774 (Part B) Experimental Treatment 1 Intervention

Repeat doses of LY3561774 administered SC.

Group III: LY3561774 (Part A) Experimental Treatment 1 Intervention

Single ascending doses of LY3561774 administered subcutaneously (SC).

Group IV: Placebo (Part A, B & C) Placebo Group 1 Intervention

Placebo administered SC.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

Alectinib demonstrated a significant objective response rate of 51.3% in patients with ALK-positive non-small cell lung cancer (NSCLC) who had previously progressed on crizotinib, based on pooled data from 225 patients across two phase II studies.

The treatment showed an acceptable safety profile, with 40% of patients experiencing grade 3 or higher adverse events, and a median overall survival of 26.0 months, indicating both efficacy and manageable safety in a longer follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pooled Systemic Efficacy and Safety Data from the Pivotal Phase II Studies (NP28673 and NP28761) of Alectinib in ALK-positive Non-Small Cell Lung Cancer. Yang, JC., Ou, SI., De Petris, L., et al.[2022]

In a review of 24 Phase I studies involving 430 healthy male volunteers over 5 years, the overall incidence of adverse events was 13.5%, with a higher rate for active drug treatments (15.3%) compared to placebo (7.4%).

Severe adverse events occurred in 20 cases (0.36%), but there were no deaths or life-threatening incidents, indicating that while adverse events are common, they are generally not severe in Phase I trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase one studies: a study in 430 healthy volunteers. Sibille, M., Deigat, N., Olagnier, V., et al.[2019]

A safety analysis of ubrogepant and rimegepant, based on 2010 and 3691 adverse event reports respectively, identified 10 and 25 significant safety signals, indicating potential risks associated with these medications.

The adverse events reported were primarily related to psychiatric, neurological, gastrointestinal, skin, vascular, and infectious issues, highlighting the need for further research to confirm these safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant and rimegepant: signal detection using spontaneous reports of adverse events from the Food and Drug Administration Adverse Event Reporting System. Battini, V., Carnovale, C., Clementi, E., et al.[2023]

A disproportionality analysis of 33,327 reports identified 687 cases of adverse reactions associated with alpelisib, with hyperglycaemia being the most significant adverse event, indicating a strong association with this medication.

The most frequently reported adverse events included hyperglycaemia, rash, and diarrhoea, highlighting the need for monitoring these effects in patients receiving alpelisib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of alpelisib: A postmarketing study of the World Health Organization pharmacovigilance database. Chen, X., Wei, L., Chi, L., et al.[2022]

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05256654

NCT05256654 | A Study of LY3561774 in Participants With ... This a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy and safety of LY3561774 administered ...

2. trials.lilly.com trials.lilly.com/en-US/trial/334935

A Study of LY3561774 in Participants With Mixed ... - Lilly Trials This is a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy and safety of LY3561774 injected ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05256654?cond=%22Metabolic%20Diseases%22&viewType=Table&rank=6&tab=results

A Study of LY3561774 in Participants With Mixed Dyslipidemia The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

4. ctv.veeva.com ctv.veeva.com/study/a-study-of-ly3561774-in-participants-with-mixed-dyslipidemia

A Study of LY3561774 in Participants With Mixed Dyslipidemia A multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy and safety of LY3561774 administered subcutaneously.

5. withpower.com withpower.com/trial/phase-1-dyslipidemias-10-2020-e93cc

A Study of LY3561774 in Participants With Dyslipidemia Alectinib demonstrated a significant objective response rate of 51.3% in patients with ALK-positive non-small cell lung cancer (NSCLC) who had previously ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40158211

Effect of ANGPTL3 Inhibition With Solbinsiran in Preclinical ... Adverse events were mostly mild in severity, with similar incidence in solbinsiran- and placebo-treated participants. Conclusions ...

7. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)00507-0/fulltext

a double-blind, randomised, placebo-controlled, phase 2 trial Hepatic MRI assessment, performed in all patients before and after 6 months of treatment, showed no evidence of dose-dependent adverse effects ...

8. jacc.org jacc.org/doi/10.1016/j.jacc.2025.03.005

Effect of ANGPTL3 Inhibition With Solbinsiran in Preclinical ... The repeat-dose study demonstrated reductions in ANGPTL3 of 89% ± 6%, triglycerides up to 70% ± 13%, LDL cholesterol up to 42% ± 14%, non–high- ...