Last Update: Mar 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:
Novartis Reference Number:CDII235A12201
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).

Lipoprotein Disorder
Phase2
Recruiting
200
Dec 05, 2025
Sep 08, 2028
All
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

Warendorf,48231,Germany

Novartis Investigative Site

Recruiting

Munich,Bavaria,81377,Germany

Novartis Investigative Site

Recruiting

Potsdam,Brandenburg,14473,Germany

Novartis Investigative Site

Recruiting

Frankfurt am Main,Hesse,60594,Germany

Novartis Investigative Site

Recruiting

Essen,45147,Germany

Novartis Investigative Site

Recruiting

Essen,45359,Germany

Novartis Investigative Site

Recruiting

Gladbeck,45968,Germany

Novartis Investigative Site

Recruiting

Magdeburg,39120,Germany

Novartis Investigative Site

Recruiting

Münster,48145,Germany

Novartis Investigative Site

Recruiting

Kaiserslautern,Rhineland-Palatinate,67655,Germany

Novartis Investigative Site

Recruiting

Rüdersdorf,15562,Germany

Novartis Investigative Site

Recruiting

Rostock,18057,Germany

Novartis Investigative Site

Recruiting

Papenburg,26871,Germany

Novartis Investigative Site

Recruiting

Dortmund,44137,Germany

Novartis Investigative Site

Recruiting

Berlin,10787,Germany

Novartis Investigative Site

Recruiting

Bad Krozingen,79189,Germany

Novartis Investigative Site

Recruiting

Dresden,Saxony,01307,Germany

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

Takamatsu,Kagawa-ken,760 8557,Japan

Novartis Investigative Site

Recruiting

Kyoto,6078062,Japan

Novartis Investigative Site

Recruiting

Shinjuku Ku,Tokyo,160-0008,Japan

Metropolitan Cardiovascular Consultants Llc

Recruiting

Beltsville,Maryland,20705,United States

Ayim Akyea-Djamson
Nibras Seman

MultiCare Ins Research Innovation

Recruiting

Puyallup,Washington,98372,United States

Vinay Malhotra
Fawna White

Cardiology Consultants of Philadelphia

Recruiting

Yardley,Pennsylvania,19067,United States

Sharon Budzinski
Paul Grena

Ocala Cardiovascular Research

Recruiting

Ocala,Florida,34471,United States

Arleana Brown
Lan Luo

Cardiology Partners Clinical Research Institute

Recruiting

Wellington,Florida,33449,United States

Duccio Baldari
Elizabeth Dagher

AMR Chicago

Recruiting

Oak Brook,Illinois,60523,United States

Loria Awadallah
Saifullah Nasir

Alliance for Multispecialty Research

Recruiting

Wichita,Kansas,67207,United States

Jerry Punch
Shaunacie Mc Callum

CV Ins of the South

Recruiting

Lafayette,Louisiana,70503,United States

Ariel Quebedeaux
Wade May

SEC Clinical Research

Recruiting

Pensacola,Florida,32503,United States

Tatum Ramsey
William Doty

Capitol Cardiology Associates

Recruiting

Lanham,Maryland,20706,United States

Iluyomade Adeusi
Vineet Venugopal

Dominion Medical Associates

Recruiting

Richmond,Virginia,23219,United States

Richard A Jackson
Adrian Knight

Cardiology Associates of North MS

Recruiting

Tupelo,Mississippi,38801,United States

Henry Baker Boler
Brittany Cook

Trinity Health Michigan Heart

Recruiting

Ypsilanti,Michigan,48197,United States

Martha Bohn
Ahmad Mizyed

Monroe Research Llc

Recruiting

West Monroe,Louisiana,71291,United States

Nina Parrott
Assad Mouhaffel

TCV Clinical Studies

Recruiting

Linwood,Pennsylvania,19061,United States

Edward Stankiewicz
Michael Cosgrove

National Heart Institute

Recruiting

Beverly Hills,California,90211,United States

Norman Lepor
Maria Flores

Heart Center Research Llc

Recruiting

Huntsville,Alabama,35801,United States

Vernon R Hunter
Amy Williams

Northwest Houston Clinical Research PLLC

Recruiting

Tomball,Texas,77375,United States

Shamaila Aslam
Dawn Burns

Angiocardiac Care of Texas PA

Recruiting

Houston,Texas,77025,United States

Amin Karim
Alexis Sincere

Apex Cardiology Research Associates of Jackson

Recruiting

Jackson,Tennessee,38301,United States

Mohsin Alhaddad
Leslie Gibbons

Alliance Clinical

Recruiting

Canoga Park,California,91303,United States

Anitha Roobalingam
Hessam Aazami

Inpatient Research Clinical LLC

Recruiting

Miami Lakes,Florida,33014,United States

Sergio Ramirez
Jose Contreras
Jose Casola
Alexis Gutierrez

Zenith Clinical Research

Recruiting

Hollywood,Florida,33021,United States

Yeny Ramos
Moises Issa

Excel Medical Clinical Trials LLC

Recruiting

Boca Raton,Florida,33434,United States

Rasha Youssef
Jennifer Austin

Cardiology and Medicine Clinic PA

Recruiting

Little Rock,Arkansas,72204,United States

Sherry Clements
Joe L Hargrove

Parkway Medical Center

Recruiting

Birmingham,Alabama,35215,United States

Paula Sullivan
James Sullivan

AA Medical Research Center

Recruiting

Flint,Michigan,48504,United States

Fayyaz Shah
Ahmed A Arif

Progressive Clinical Research

Recruiting

Bountiful,Utah,84010,United States

Madie Toole
Joshua Oaks

Clinical Trials of Texas

Recruiting

San Antonio,Texas,78229,United States

Libby Knight
Douglas Denham

Dallas Heart and Vascular Consultants PA

Recruiting

Houston,Texas,77084,United States

Shirmia Artis Stephens
Imran Afridi

K and R Research LLC

Recruiting

Marion,Ohio,43302,United States

Rhonda Rudd
Parminder Singh

AB Clinical Trials

Recruiting

Las Vegas,Nevada,89119,United States

Fungai Siziba-Dubose
Atoya Adams

Anderson Medical Research

Recruiting

Ft. Washington,Maryland,20744,United States

Felton Anderson
Ann-Marie Cobb

Atlanta Heart Specialists LLC

Recruiting

Tucker,Georgia,30084,United States

Hiwot Haile
David Suh

Flourish Res Acq LLC North Miami

Recruiting

Miami,Florida,33138,United States

Rimsky Denis
Ashlee Sealy

Jacksonville Center for Clinical Research

Recruiting

Jacksonville,Florida,32216,United States

Zoe Winans
Michael J Koren

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals