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Study of LY3819469 for Adults with High Lipoprotein(a) Levels

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What is this study about?

This clinical trial is focused on studying a condition known as elevated lipoprotein(a), which is a type of lipoprotein disorder. Lipoproteins are particles in the blood that carry cholesterol and other fats. When levels of lipoprotein(a) are high, it can increase the risk of heart disease. The study is testing a new treatment called LY3819469, which is a solution for injection developed by Eli Lilly and Company. This treatment is being compared to a placebo to see if it can effectively reduce the levels of lipoprotein(a) in the blood.

The purpose of the study is to determine if LY3819469 is better than a placebo in lowering lipoprotein(a) levels. Participants in the study will receive either the treatment or a placebo through an injection under the skin, known as a subcutaneous injection. The study will last for a period of time, during which participants will be monitored to see how their lipoprotein(a) levels change. The maximum daily dose of the treatment is 400 milligrams, and the total dose over the course of the study can be up to 800 milligrams.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The study aims to provide valuable information on the safety and effectiveness of LY3819469 for people with elevated lipoprotein(a) levels, potentially leading to new treatment options for this condition.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the investigational medication LY3819469 or a placebo. A placebo is a substance that looks like the medication but does not contain the active ingredient.

2 medication administration

The medication or placebo will be given as a solution for injection under the skin, known as a subcutaneous injection. The exact dosage and frequency will be determined by the study team and communicated to you.

3 treatment period

The treatment period will last for several months. During this time, you will continue to receive the injections as scheduled. The main goal is to evaluate the effect of the medication on reducing lipoprotein(a) levels in your blood.

4 monitoring and assessments

Throughout the study, regular monitoring and assessments will be conducted. This includes blood tests to measure lipoprotein(a) levels and other health checks to ensure your safety and well-being.

5 end of study

The study is expected to conclude by January 16, 2024. At the end of the study, a final assessment will be conducted to evaluate the overall effects of the treatment.

Who Can Join the Study?

  • Participants must be at least 40 years old.
  • Participants must have a level of Lp(a) (a type of fat in the blood) of at least 175 nmol/L at screening.
  • If participants are taking lipid-lowering drugs (medications to reduce fats in the blood) or hormone therapy, they need to be on a stable dose for at least 4 weeks before screening.
  • Participants must have a body mass index (BMI) between 18.5 and 40. BMI is a measure of body fat based on height and weight.
  • Males must agree to use highly effective contraception methods, or participants must be women who are not of childbearing age.

Who Cannot Join the Study?

  • Patients with any other serious health condition that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients with a history of allergic reactions to the study medication.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients with a history of drug or alcohol abuse within the past year.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver or kidney disease.
  • Patients with a history of heart attack or stroke within the last 6 months.
  • Patients who are currently taking medications that might interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain

Other Sites

Site Name City Country Status
Amphia Hospital Breda The Netherlands
MVZ CCB Frankfurt Und Main-Taunus GbR Frankfurt Germany
Sal Med S.R.L. Pitesti Romania
Sanos A/S Gandrup Denmark
Reinier de Graaf Groep Delft The Netherlands
Saxenburgh Medisch Centrum Hardenberg The Netherlands
Vujauq dda Rmoal Uvhwgxagzi Hcknxunw Sevilla Spain
Cpyaifb Myfqali Dw Dhfmpmiysq Sp Tbwpzersf Awkmsydcl Nzmxhx Sxluxc Brasov Romania
Hmepsfle Uqydxizkousbh Vkknyl Dl Lzf Nwjlin Granada Spain
Mywizhp Spptrtyo Tnkziy Enschede The Netherlands
Hzjklimv Mfqxory Suiqoqhd Swyfvs Bucharest Romania
Cqxepbxqx Scbuli Iasi Romania
Cxw Dkg Pmtkdwmtg Ccskoowe Targu Mures Romania
Ctgxlurqbl Dlczliqzyk Targu Mures Romania
Pnzrjznxposgb De Usafcb Wjdiowgc Dy Dzuerke Dkjk Umg Pdim Dt Jhfj Avkwye Hamburg Germany
Ctu Crxiwfxdcqywrue Mbktmj Cwaujo Dkynq Baia Mare Romania
Gfgmos Hagb Zzfbwlqepv Gouda The Netherlands
Slwnrkkyaa Cjnnib Mkimfhkq Dlp Pubyljq Bucharest Romania
Magihqqsmrizbquc Soeifw Timisoara Romania
D &coig A Rakbofje Bvqd Sneek The Netherlands
Sug Mr Gnot Magdeburg Germany
Ctgpnzkgmteuz Hbxyxdw Gpg Hamburg Germany
Mstymfjrqphmn Vgwchyxnzpxzuyuqdl Aj Bqjilet Sywdfxa Gsh Berlin Germany
Khigfpmr Bosnxmpbh ghjyg Bielefeld Germany
Hqdrgjcr Updidofocpgqp Haaflhfo Txlsf y Puwpvi Ifayjlff Cykpnb dyspvuljfmnqkipjy (soia Badalona Spain
Pmpicv Dkd Jfyroxmx Bad Homburg Germany
Knpbxktdsyhpwp Pyhqlg ib Syuhenrhhs Berlin Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
31.10.2022
Germany Germany
Not recruiting
31.10.2022
Romania Romania
Not recruiting
31.10.2022
Spain Spain
Not recruiting
31.10.2022
The Netherlands The Netherlands
Not recruiting
31.10.2022

Trial locations

Investigated Drugs:

LY3819469 is a medication being studied to see if it can help lower levels of a specific type of fat in the blood called lipoprotein(a), or Lp(a). High levels of Lp(a) can increase the risk of heart disease. This medication is being tested to find out if it can reduce Lp(a) levels more effectively than a placebo, which is a substance with no active ingredients used for comparison in clinical trials. The goal is to determine if LY3819469 can be a safe and effective treatment for people with elevated Lp(a) levels.

Investigated Diseases:

Lipoprotein Disorder – Lipoprotein disorder involves abnormalities in the levels or types of lipoproteins in the blood. Lipoproteins are particles that transport cholesterol and triglycerides through the bloodstream. This disorder can lead to an imbalance, causing either high or low levels of lipoproteins. Over time, these imbalances can contribute to the buildup of fatty deposits in blood vessels. This can affect blood flow and potentially lead to complications in the cardiovascular system. The progression of the disorder depends on the specific type and severity of the lipoprotein imbalance.

Trial ID:
2022-501426-38-00
Protocol code:
18547
Trial Phase:
Therapeutic exploratory (Phase II)

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