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

Last Update: Feb 03, 2026

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)

ClinicalTrials.gov Identifier:

NCT07235046

Novartis Reference Number:CDII235A12201

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

The main purpose of this study is to determine the safety and efficacy of DII235 in adults with elevated lipoprotein(a).

Condition

Lipoprotein Disorder

Phase

Phase2

Overall Status

Recruiting

Number of Participants

200

Start Date

Dec 02, 2025

Completion Date

Sep 08, 2028

Gender

All

Age(s)

18 Years - 80 Years (Adult, Older Adult)

Interventions

Drug

DII235

Solution for injection

Drug

Saline

solution for injection

Eligibility 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

Novartis Investigative Site

Recruiting

Münster,48145,Germany

Novartis Investigative Site

Recruiting

Magdeburg,39120,Germany

Novartis Investigative Site

Recruiting

Gladbeck,45968,Germany

Novartis Investigative Site

Recruiting

Essen,45359,Germany

Novartis Investigative Site

Recruiting

Essen,45147,Germany

Novartis Investigative Site

Recruiting

Frankfurt am Main,Hesse,60594,Germany

Novartis Investigative Site

Recruiting

Potsdam,Brandenburg,14473,Germany

Novartis Investigative Site

Recruiting

Munich,Bavaria,81377,Germany

Novartis Investigative Site

Recruiting

Kyoto,6078062,Japan

Novartis Investigative Site

Recruiting

Matsudo,Chiba,270-2251,Japan

Novartis Investigative Site

Recruiting

Miyhazaki,Miyazaki,8802102,Japan

Novartis Investigative Site

Recruiting

Suita,Osaka,5650853,Japan

Novartis Investigative Site

Recruiting

Shinjuku Ku,Tokyo,160-0008,Japan

Novartis Investigative Site

Recruiting

Takamatsu,Kagawa-ken,760 8557,Japan

Capitol Cardiology Associates

Recruiting

Lanham,Maryland,20706,United States

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

Study Description

Interventions

DII235

Saline

Eligibility Criteria

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Capitol Cardiology Associates

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Iluyomade Adeusi

K and R Research LLC

Rhonda Rudd

Parminder Singh

Dallas Heart and Vascular Consultants PA

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Sana Pirani

Shirmia Artis Stephens

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Clinical Trials of Texas

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Progressive Clinical Research

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Dominion Medical Associates

Adrian Knight

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Metropolitan Cardiovascular Consultants Llc

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Ocala Cardiovascular Research

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Cardiology Partners Clinical Research Institute

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Elizabeth Dagher

AMR Chicago

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Alliance for Multispecialty Research

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CV Ins of the South

Ariel Quebedeaux

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Inpatient Research Clinical LLC

Jose Casola

Sergio Ramirez

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Northwest Houston Clinical Research PLLC

Dawn Burns

Shamaila Aslam

Angiocardiac Care of Texas PA

Amin Karim

Alexis Sincere

Apex Cardiology Research Associates of Jackson

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TCV Clinical Studies

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Zenith Clinical Research

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Excel Medical Clinical Trials LLC

Rasha Youssef