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LY3561774 for Mixed Dyslipidemia (PROLONG-ANG3 Trial)
Phase 2
Waitlist Available
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
Must be on a stable moderate or high-intensity dose of a statin for at least 2 months before screening and remain on the same medication and dose for the duration of the study
Be older than 18 years old
Must not have
Have a history of acute or chronic pancreatitis
Have uncontrolled hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial is testing a new medication called LY3561774. It targets patients with abnormal blood fat levels who are already taking statins. The goal is to see if LY3561774 can further improve their blood fat levels.
Who is the study for?
This trial is for adults with mixed dyslipidemia who have high LDL cholesterol (≥100 mg/dL) and triglycerides (200-499 mg/dL), a BMI of 18.5 to 40 kg/m², and are on a stable statin dose. Excluded are those with recent severe cardiovascular events, heart failure, procedures affecting lipids or obesity surgery within the last year, uncontrolled hypertension or diabetes.
What is being tested?
The study tests LY3561774's effectiveness in lowering lipid levels compared to placebo in participants with mixed dyslipidemia already taking statins. It's a Phase 2b trial where patients receive either the drug or placebo through injections while their usual statin treatment continues.
What are the potential side effects?
Potential side effects of LY3561774 may include reactions at the injection site, changes in liver enzymes or fat levels that could affect organ function, muscle pain or weakness especially when combined with statins.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on a consistent dose of a strong statin for at least 2 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had pancreatitis before.
Select...
My high blood pressure is not under control.
Select...
I have had nephrotic syndrome in the past.
Select...
I have not had severe diabetes issues or an HbA1c ≥8% in the last 6 months.
Select...
My heart's pumping ability is severely reduced.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3561774 Dose 3Experimental Treatment1 Intervention
Participants will receive LY3561774 SC
Group II: LY3561774 Dose 2Experimental Treatment1 Intervention
Participants will receive LY3561774 SC
Group III: LY3561774 Dose 1Experimental Treatment1 Intervention
Participants will receive LY3561774 subcutaneously (SC)
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3561774
2020
Completed Phase 2
~280
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for dyslipidemia include statins, PCSK9 inhibitors, and other lipid-lowering agents. Statins inhibit the enzyme HMG-CoA reductase, reducing cholesterol synthesis in the liver.
PCSK9 inhibitors, such as alirocumab and evolocumab, block the PCSK9 protein, increasing LDL receptors on liver cells and enhancing LDL cholesterol clearance. Ezetimibe reduces cholesterol absorption in the intestines.
These treatments are vital for dyslipidemia patients as they lower LDL cholesterol levels, thereby decreasing the risk of cardiovascular events like heart attacks and strokes.
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,675 Previous Clinical Trials
3,463,779 Total Patients Enrolled
11 Trials studying Diabetes
15,619 Patients Enrolled for Diabetes
Study DirectorEli Lilly and Company
1,388 Previous Clinical Trials
427,174 Total Patients Enrolled
3 Trials studying Diabetes
4,328 Patients Enrolled for Diabetes
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor has diagnosed me with significant anemia.I have been on a consistent dose of a strong statin for at least 2 months.I have had or plan to have weight loss surgery within a year.I am using products to lower my cholesterol levels, but not statins, PCSK9 inhibitors, bempedoic acid, or ezetimibe.I have had pancreatitis before.My high blood pressure is not under control.I have had nephrotic syndrome in the past.I have had LDL apheresis in the last 12 months.I have had a heart attack, stroke, or other major heart issues in the last 3 months.I have not had severe diabetes issues or an HbA1c ≥8% in the last 6 months.My heart's pumping ability is severely reduced.
Research Study Groups:
This trial has the following groups:- Group 1: LY3561774 Dose 1
- Group 2: LY3561774 Dose 2
- Group 3: LY3561774 Dose 3
- Group 4: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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