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A Study of DII235 for Elevated Lipoprotein(a)

This study is testing an investigational drug called DII235 to see if it is safe and effective in adults with high levels of lipoprotein(a) (Lp(a)). Lp(a) is a type of fat and protein in your blood that can increase your risk of heart disease. You may be able to join if you are between 18 and 80 years old, have Lp(a) levels of 150 nmol/L or higher, and have existing heart disease or type 2 diabetes. Researchers will measure how much DII235 changes your Lp(a) levels over time, compared to a placebo (saline injection). The study aims to enroll 233 participants.

Study design
This interventional study is testing DII235 against a placebo (saline) in adults. It plans to enroll 233 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure changes in Lp(a) levels between Day 60 and Day 180, and between Day 60 and Day 360.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07235046

A Study of DII235 in Adults With Elevated Lipoprotein(a)

Active, Not Recruiting
PHASE2Ages 18–80InterventionalTreatment
Novartis Pharmaceuticals
~234 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:DII235Saline

At a glance

Recruiting sites
0 of 63 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time averaged percentage change from baseline between Day 60 and Day 180
Measured over baseline to day 60 and day 180
+2 more outcomes measured

Conditions

Lipoprotein Disorder

Explore related trials

AtherosclerosisLipoprotein DisorderType 2 Diabetes MellitusApolipoprotein(a)

Where it's being run

63 sites across 34 states
Germany11
Florida8
Texas5
Maryland3
Alabama2
California2
Louisiana2
Michigan2

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Time averaged percentage change from baseline between Day 60 and Day 180baseline to day 60 and day 180

    Time averaged change from baseline in log Lp(a) measured between Day 60 and Day 180, defined as the area under the curve (AUC) between the Day 60 Visit date and the Day 180 Visit date, divided by the duration between the two visit dates.

  • Difference between DII235 dose 2 and placebo in time-averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360baseline to day 60 and day 360

    Time averaged change from baseline in log Lp(a) measured between Day 60 and Day 360, defined as the area under the curve (AUC) between the Day 60 visit date and the Day 360 visit date, divided by the duration between the two visit dates.

  • Difference between DII235 dose 4 and placebo in time-averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360baseline to day 60 and day 360

    Time averaged change from baseline in log Lp(a) measured between Day 60 and Day 360, defined as the area under the curve (AUC) between the Day 60 visit date and the Day 360 visit date, divided by the duration between the two visit dates.