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

Last Update: Dec 30, 2025

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

Suita,Osaka,5650853,Japan

Novartis Investigative Site

Recruiting

Miyhazaki,Miyazaki,8802102,Japan

Novartis Investigative Site

Recruiting

Matsudo,Chiba,270-2251,Japan

Novartis Investigative Site

Recruiting

Shinjuku Ku,Tokyo,160-0008,Japan

Flourish Res Acq LLC North Miami

Recruiting

Miami,Florida,33138,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

Flourish Res Acq LLC North Miami

Ashlee Sealy

Rimsky Denis

Jacksonville Center for Clinical Research

Michael J Koren

Marijana Lukovic

Atlanta Heart Specialists LLC

David Suh

Hiwot Haile

Cardiovascular

Loria Awadallah

Saifullah Nasir

Anderson Medical Research

Ann-Marie Cobb

Felton Anderson

AA Medical Research Center

Ahmed A Arif

Fayyaz Shah

AB Clinical Trials

Atoya Adams

Fungai Siziba-Dubose

K and R Research LLC

Parminder Singh

Rhonda Rudd

Dallas Heart and Vascular Consultants PA

Imran Afridi

Sana Pirani

Shirmia Artis Stephens

Syed Humayun Naqvi

Clinical Trials of Texas

Douglas Denham

Libby Knight

Progressive Clinical Research

Joshua Oaks

Madie Toole

Dominion Medical Associates

Adrian Knight

Richard A Jackson

Apex Cardiology Research Associates of Jackson

Cara Roberson

Mohsin Alhaddad

Parkway Medical Center

Paula Sullivan

James Sullivan

Cardiology and Medicine Clinic PA

Joe L Hargrove

Sherry Clements

Excel Medical Clinical Trials LLC

Jennifer Austin

Rasha Youssef

Zenith Clinical Research

Moises Issa

Yeny Ramos

Inpatient Research Clinical LLC

Alexis Gutierrez

Jose Casola

Jose Contreras

Sergio Ramirez

TCV Clinical Studies

Edward Stankiewicz

Michael Cosgrove

Angiocardiac Care of Texas PA

Alexis Sincere

Amin Karim

Northwest Houston Clinical Research PLLC

Dawn Burns

Shamaila Aslam

Heart Center Research Llc

Amy Williams

Vernon R Hunter