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DII235 for adults with high lipoprotein(a)

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate Efficacy, Safety, and Tolerability of DII235 in Adults With Elevated Lipoprotein(a)

PHASE2 · Novartis · NCT07235046

This trial tests whether DII235 is safe and can lower very high lipoprotein(a) in adults with elevated Lp(a) who have atherosclerotic cardiovascular disease or type 2 diabetes.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorNovartis (industry)
Locations66 sites (Birmingham, Alabama and 65 other locations)
Trial IDNCT07235046 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial gives adults with Lp(a) ≥150 nmol/L and evidence of atherosclerotic cardiovascular disease and/or type 2 diabetes either DII235 or saline, with dosing and schedule defined in the protocol. Participants are screened using a central laboratory measurement of Lp(a) and are monitored for safety, tolerability, and changes in Lp(a) and cardiovascular biomarkers during the treatment period. The trial is sponsored by Novartis and conducted at several US cardiology centers, and excludes people with significant renal or hepatic dysfunction, recent malignancy, or other conditions that could affect safety or data interpretation. Results will provide preliminary safety and efficacy signals to guide larger trials.

Who should consider this trial

Good fit: Adults aged 18–80 with Lp(a) ≥150 nmol/L and evidence of atherosclerotic cardiovascular disease and/or type 2 diabetes who meet the study's health criteria are the intended participants.

Not a fit: People with severe kidney or liver dysfunction, recent cancer, those using other investigational drugs, or other unstable medical or psychiatric conditions are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, DII235 may significantly lower Lp(a) levels and potentially reduce cardiovascular risk in people with very high Lp(a).

How similar studies have performed: Other Lp(a)-lowering approaches such as antisense oligonucleotides and siRNA have shown substantial Lp(a) reductions in prior trials, but DII235 appears to be a novel agent still under early testing.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.
* Participants with evidence of atherosclerotic cardiovascular disease and/or type 2 diabetes mellitus.

Exclusion Criteria:

* Severe renal dysfunction
* Hepatic dysfunction
* Malignancy within the last 5 years
* Use of investigational medications as defined in the protocol
* History or presence at screening of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the Investigator, or sponsor if consulted, would potentially affect participant safety within the study or interfere with participating in or completing the study or with the interpretation of data

Other protocol-defined inclusion/exclusion criteria may apply

Where this trial is running

Birmingham, Alabama and 65 other locations

+16 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Lipoprotein Disorder, Lipoprotein, cardiovascular disease, atherosclerotic cardiovascular disease, lipoprotein disorder, cardiovascular, cholesterol, hyperlipidemia

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.