Authorised Therapeutic exploratory (Phase II) Cardiovascular risk reduction in participants with elevated Lp(a)

A clinical trial to learn more about the effects of DII235 in people with high levels of lipoprotein(a)

EU CTIS ID: 2025-521912-21-00

What this study is testing

1. To evaluate the dose-response relationship of DII235 administered as compared to placebo on time averaged percentage change from baseline of Lp(a) in adults with elevated Lp(a) (defined as Lp(a) ≥ 150 nmol/L). 2. To evaluate the efficacy of DII235 versus placebo in time averaged percent change from baseline in Lp(a) between Day 60 and Day 360.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Signed informed consent must be obtained prior to participation in the study.
  • Male or female participants 18 to 80 years of age (inclusive) at the screening.
  • Lp(a) ≥ 150 nmol/L at screening, measured at the central laboratory.
  • Presence of ASCVD and/or Type 2 diabetes mellitus (T2DM). Diagnosis of ASCVD should be based on at least one of the following: a. Coronary heart disease (CHD): • Prior myocardial infarction (MI) of presumed atherosclerotic origin, which occurred ≥ 12 weeks prior to the Screening Visit • Prior coronary revascularization (PCI or CABG) that occurred ≥ 12 weeks prior to the Screening Visit • Angiographic or CT-imaging (e.g., MDCT/CTA) evidence of coronary atherosclerosis: ≥50% stenosis in at least one major epicardial coronary artery • Coronary artery calcium (CAC) score of ≥ 300 AU by computed tomography (if a participant has T2DM CAC score of ≥ 100 AU is sufficient to define ASCVD) And/or b. Cerebrovascular disease (CeVD): • Prior ischemic stroke, which occurred ≥ 12 weeks prior to the Screening Visit, confirmed by documented brain imaging (CT or MRI); embolic stroke (not of atherosclerotic origin) is not a qualifying event. • History of percutaneous or surgical carotid artery revascularization that occurred ≥ 12 weeks prior to the Screening Visit • Carotid artery stenosis ≥ 70% or symptomatic carotid artery disease with ≥ 50% carotid arterial stenosis on prior angiography or ultrasound And/or c. Peripheral arterial disease (PAD): • Prior non-traumatic amputation of a lower extremity due to peripheral artery disease • History of prior percutaneous or surgical revascularization of iliac, femoral, or popliteal artery • Prior documentation of a resting ankle-brachial index ≤ 0.9 On standard of care treatment for ASCVD risk factors (according to local guidelines and per Investigator discretion). Participants receiving lipid lowering therapy (including statins, ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody inhibitors must be on a stable regimen per local guidelines prior to screening, with no planned changes made after screening, and expected to remain on a stable regimen through the end of the treatment (as statins may raise Lp(a) concentrations). A stable dose is defined as at least 8 weeks of treatment at a consistent dose level for monoclonal antibody PCSK9 inhibitors, and at least 4 weeks for all other LLT.

You likely can't join if

  • Acute cardiovascular event (e.g., acute myocardial infarction or unstable angina, CABG, stroke, TIA) within 12 weeks before screening
  • Renal dysfunction with eGFR ≤ 30 mL/min/1.73 m2 (using CKD-EPI formula) at screening
  • Positive human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen tests from central laboratory at Screening Visit.
  • Hepatic dysfunction based on liver function tests at screening (defined as AST or ALT > 2 × ULN or total bilirubin > 1.5 × ULN at screening) (participants with Gilbert’s syndrome are allowed if total bilirubin < 2 × ULN)
  • Current or prior history of moderate to severe heart failure of NYHA Class III or IV, or known LVEF < 30% at screening
  • Uncontrolled cardiac arrhythmia

The study team makes the final eligibility decision.

Where it's taking place

  • United States
  • Japan
  • China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; Japan; China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.