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A study testing DII235 compared to placebo in adults with high lipoprotein(a) levels to reduce heart disease risk

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at people who have high levels of a substance called lipoprotein(a) in their blood. Lipoprotein(a) is a type of fat-carrying particle that, when present in high amounts, may increase the risk of heart and blood vessel problems. The study will test a treatment called DII235, which is given as an injection under the skin. Some participants will receive DII235 while others will receive placebo. The treatment also involves sodium chloride and glucose monohydrate solutions that are used as part of the injection preparation.

The purpose of the study is to find out how well different doses of DII235 work in lowering lipoprotein(a) levels compared to placebo, and to check if the treatment is safe and well-tolerated. The study will also look at whether DII235 can reduce lipoprotein(a) levels to specific target amounts over time. People taking part in this study will have either existing heart and blood vessel disease, which means they have had problems like heart attacks, procedures to open blocked arteries, narrowing of arteries in the heart, brain, or legs, or they have Type 2 diabetes mellitus, which is a condition where the body does not properly control blood sugar levels.

During the study, participants will receive injections under the skin over a period of 18 months. The study doctors will measure lipoprotein(a) levels in the blood at different time points to see how much they change from the beginning of the study. Measurements will be taken at various times including around day 60, day 180, day 240, and day 360. The study will also track any unwanted effects, check blood test results, and monitor vital signs like blood pressure and heart rate to make sure the treatment is safe. Participants will need to continue taking their regular medications for heart health and cholesterol as prescribed by their doctor throughout the study.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment assignment
After joining the study, you will be randomly assigned to receive either DII235 or placebo. A placebo is an inactive substance that looks like the study medication but contains no active ingredient.
Neither you nor your doctor will know which treatment you are receiving. This is called a double-blind study design.
The medication will be administered as a subcutaneous injection, which means it will be injected under your skin.
Step 2
Treatment period from Day 1 to Day 360
You will receive regular injections of either DII235 or placebo under your skin throughout the treatment period.
The total treatment duration will last approximately 360 days (about 12 months).
The specific dosage and frequency of injections will be determined by the study protocol and your assigned treatment group.
During this time, you are expected to continue taking your current medications for heart disease risk factors, including any lipid-lowering medications such as statins, ezetimibe, or PCSK9 inhibitors. These are medications that help control cholesterol levels in your blood.
Step 3
Blood testing at Day 60
At approximately Day 60 (about 2 months after starting treatment), blood samples will be taken to measure your lipoprotein(a) levels. Lipoprotein(a), also written as Lp(a), is a type of fat particle in your blood.
This measurement will serve as an important checkpoint to evaluate how the treatment is affecting your Lp(a) levels.
Step 4
Blood testing at Day 180
At approximately Day 180 (about 6 months after starting treatment), additional blood samples will be collected to measure your Lp(a) levels.
The results will be compared to your initial levels to determine the percentage change in your Lp(a).
Your doctor will also assess whether your Lp(a) levels have decreased to below 125 nmol/L or below 75 nmol/L. These are specific target levels used to evaluate treatment effectiveness.
Step 5
Blood testing at Day 240
At approximately Day 240 (about 8 months after starting treatment), blood samples will be taken again to continue monitoring your Lp(a) levels.
This measurement helps track the ongoing effects of the treatment over time.
Step 6
Final blood testing at Day 360
At approximately Day 360 (about 12 months after starting treatment), final blood samples will be collected to measure your Lp(a) levels.
The results from all time points will be averaged to calculate the overall change in your Lp(a) levels throughout the study.
Your doctor will again assess whether your Lp(a) levels have reached the target levels of below 125 nmol/L or below 75 nmol/L.
Step 7
Safety monitoring throughout the study
Throughout the entire study period, you will be monitored for any adverse events, which are any unwanted or unexpected medical occurrences.
Regular blood tests will be performed to check safety laboratory parameters, which are routine blood tests that help ensure the treatment is not causing harmful effects on your body.
Vital signs such as blood pressure, heart rate, and temperature will be measured at regular intervals.
All safety information will be collected and evaluated to assess the tolerability of the treatment.

Who can join the trial?

7 criteria

You must sign an informed consent form before joining the study
You must be between 18 and 80 years old at the time of screening
Your blood level of Lp(a) must be at least 150 nmol/L at screening. Lp(a) is a type of cholesterol particle in your blood that can increase the risk of heart disease
You must have been diagnosed with ASCVD, which means atherosclerotic cardiovascular disease, a condition where fatty deposits build up in your arteries, or Type 2 diabetes mellitus, a condition where your body does not properly control blood sugar levels. ASCVD can be confirmed by at least one of the following conditions:
- Heart-related conditions such as a previous heart attack that occurred at least 12 weeks before screening, or a previous procedure to open blocked heart arteries that occurred at least 12 weeks before screening, or imaging tests showing significant narrowing of heart arteries, or a calcium score of at least 300 in your heart arteries, or at least 100 if you have Type 2 diabetes. The calcium score measures the amount of calcium buildup in your heart arteries
- Brain-related conditions such as a previous ischemic stroke, which is when blood flow to part of the brain is blocked, that occurred at least 12 weeks before screening and was confirmed by brain imaging, or a previous procedure to open blocked neck arteries that occurred at least 12 weeks before screening, or significant narrowing of the arteries in your neck
- Leg artery-related conditions such as a previous amputation of a lower limb due to poor blood flow, or a previous procedure to open blocked arteries in your legs, or test results showing reduced blood flow to your legs
- You must be receiving standard treatment for cardiovascular risk factors according to local guidelines. If you are taking lipid lowering therapy, which are medications to reduce cholesterol and fats in your blood, including statins, ezetimibe, or PCSK9 inhibitors, you must have been on a stable dose for at least 4 weeks before screening, with no planned changes, and you are expected to stay on the same dose throughout the study

Who cannot join the trial?

10 criteria

The study does not list specific exclusion criteria in the provided information, but participants must meet certain requirements to join
You cannot participate if you do not have elevated Lp(a), which is a type of cholesterol particle in your blood that needs to be at least 150 nmol/L (a measurement unit for the amount of this substance in your blood)
You may not be eligible if you are outside the specified age range for this study
Certain medical conditions or treatments may prevent you from joining, though specific details are not provided in the available information
If you are taking medications that could interfere with the study drug or affect the results, you may not be able to participate
Women who are pregnant, planning to become pregnant, or breastfeeding are typically not allowed to join studies like this one
If you have severe kidney disease (when your kidneys do not work properly to filter waste from your blood) or liver disease (when your liver cannot perform its normal functions), you may be excluded
Recent heart attack (damage to the heart muscle due to blocked blood flow) or stroke (damage to the brain due to interrupted blood supply) may prevent participation
If you have uncontrolled high blood pressure or other unstable medical conditions, you may not qualify
Allergies to similar medications or components of the study drug may exclude you from participation

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
Responsive
Bad Oeynhausen, Germany
Institut fuer Diabetesforschung Muenster GmbH
Verified
Munster, Germany

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Investigated drugs

DII235
is an investigational medication being studied for its ability to lower high levels of Lipoprotein(a), also known as Lp(a), in the blood. Lipoprotein(a) is a type of cholesterol particle that, when elevated, may increase the risk of heart and blood vessel problems. This medication is being tested to see if it can reduce Lp(a) levels in adults who have higher than normal amounts of this substance in their blood.
Placebo
is an inactive substance that looks like the real medication but contains no active ingredients. It is used in this study to compare against the investigational medication to help determine if DII235 actually works to lower Lp(a) levels.

What is already known about the treatment

DII235 – DII235 is an investigational medication currently being studied in clinical trials for reducing cardiovascular risk in people with elevated lipoprotein(a), or Lp(a), which is a type of cholesterol particle in the blood that can increase heart disease risk. The drug is administered to adults who have high levels of Lp(a) and works by lowering the amount of this harmful substance in the bloodstream, though the exact molecular mechanism is still being evaluated in ongoing research. This medication is being tested in a dose-finding study to determine the most effective and safe amount to give patients, comparing different doses against a placebo (inactive treatment) over approximately one year. DII235 belongs to a class of cardiovascular medications aimed at lipid modification and falls under therapeutic areas related to heart and blood vessel health.

Investigated diseases

Elevated Lipoprotein(a) – This is a condition characterized by abnormally high levels of lipoprotein(a), also known as Lp(a), in the blood. Lipoprotein(a) is a type of fat particle that carries cholesterol through the bloodstream. When Lp(a) levels are elevated, typically defined as 150 nanomoles per liter or higher, it contributes to increased cardiovascular risk. The excess Lp(a) can accumulate in blood vessel walls, leading to narrowing and hardening of the arteries over time. This condition is largely determined by genetics and remains relatively stable throughout a person's life. The progression involves gradual buildup of these particles, which increases the likelihood of developing cardiovascular complications.