A Study of LY3561774 in Participants With Dyslipidemia

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

74 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called LY3561774 to see if it is safe and effective for people with high blood fat levels, including Japanese participants. The study will check how the body handles the medication and its impact on blood fat levels.

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.

What safety data exists for the treatment evaluated under names like LY3561774, Placebo, Control, or Dummy Treatment?

In phase I studies involving healthy volunteers, the overall incidence of adverse events was 13.5%, with a higher rate for active drugs (15.3%) compared to placebo (7.4%). Common side effects included headaches, and there were no deaths or life-threatening events reported. ^{1 2 3 4 5}

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

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

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

Treatment Details

Interventions

• LY3561774
• Placebo

Participant Groups

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

Findings from Research

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]

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]

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]

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]

References

1. England 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. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase one studies: a study in 430 healthy volunteers. [2019]

3. United States 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Adverse events of alpelisib: A postmarketing study of the World Health Organization pharmacovigilance database. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]