Last Update: Apr 01, 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).

Lipoprotein Disorder
Phase2
Recruiting
200
Dec 02, 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

Beijing,100034,China

Novartis Investigative Site

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Shenyang,Liaoning,110016,China

Novartis Investigative Site

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Bad Oeynhausen,32545,Germany

Novartis Investigative Site

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Munich,Bavaria,81377,Germany

Novartis Investigative Site

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Potsdam,Brandenburg,14473,Germany

Novartis Investigative Site

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Frankfurt am Main,Hesse,60594,Germany

Novartis Investigative Site

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Essen,45147,Germany

Novartis Investigative Site

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Essen,45359,Germany

Novartis Investigative Site

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Gladbeck,45968,Germany

Novartis Investigative Site

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Magdeburg,39120,Germany

Novartis Investigative Site

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Münster,48145,Germany

Novartis Investigative Site

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Kaiserslautern,Rhineland-Palatinate,67655,Germany

Novartis Investigative Site

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Dresden,Saxony,01307,Germany

Novartis Investigative Site

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Bad Krozingen,79189,Germany

Novartis Investigative Site

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Berlin,10787,Germany

Novartis Investigative Site

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Dortmund,44137,Germany

Novartis Investigative Site

Recruiting

Papenburg,26871,Germany

Novartis Investigative Site

Recruiting

Rostock,18057,Germany

Novartis Investigative Site

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Rüdersdorf,15562,Germany

Novartis Investigative Site

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Warendorf,48231,Germany

Novartis Investigative Site

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Kyoto,6078062,Japan

Novartis Investigative Site

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Takamatsu,Kagawa-ken,760 8557,Japan

Novartis Investigative Site

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Miyhazaki,Miyazaki,8802102,Japan

Novartis Investigative Site

Recruiting

Suita,Osaka,5650853,Japan

Novartis Investigative Site

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Matsudo,Chiba,270-2251,Japan

Novartis Investigative Site

Recruiting

Shinjuku Ku,Tokyo,160-0008,Japan

Apex Cardiology Research Associates of Jackson

Recruiting

Jackson,Tennessee,38301,United States

Mohsin Alhaddad
Leslie Gibbons
+1 731 423 8200

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
+1 318 387 1946
Assad Mouhaffel

SEC Clinical Research

Recruiting

Pensacola,Florida,32503,United States

William Doty
Tatum Ramsey
+1 850 696 7148

MultiCare Ins Research Innovation

Recruiting

Puyallup,Washington,98372,United States

Fawna White
+1 253 697 4192
Vinay Malhotra

Angiocardiac Care of Texas PA

Recruiting

Houston,Texas,77025,United States

Alexis Sincere
+1 877 339 0254
Amin Karim

Northwest Houston Clinical Research PLLC

Recruiting

Tomball,Texas,77375,United States

Dawn Burns
+1 281 351 4911
Shamaila Aslam

Heart Center Research Llc

Recruiting

Huntsville,Alabama,35801,United States

Amy Williams
Vernon R Hunter

National Heart Institute

Recruiting

Beverly Hills,California,90211,United States

Maria Flores
+1 310 289 5221
Norman Lepor

Excel Medical Clinical Trials LLC

Recruiting

Boca Raton,Florida,33434,United States

Rasha Youssef
Jennifer Austin
+1 561 756 8206

Parkway Medical Center

Recruiting

Birmingham,Alabama,35215,United States

Paula Sullivan
+1 205 815 5000
James Sullivan

Cardiology and Medicine Clinic PA

Recruiting

Little Rock,Arkansas,72204,United States

Joe L Hargrove
Sherry Clements
+1 501 664 0941

Biopharma Informatic

Recruiting

Katy,Texas,77479,United States

Syed Humayun Naqvi
Sana Pirani

Alliance for Multispecialty Research

Recruiting

Knoxville,Tennessee,67207,United States

Shaunacie Mc Callum
Jerry Punch

Zenith Clinical Research

Recruiting

Hollywood,Florida,33021,United States

Moises Issa
Yeny Ramos
+1 305 546 1311

Inpatient Research Clinical LLC

Recruiting

Miami Lakes,Florida,33014,United States

Alexis Gutierrez
Enrique Pacheco
Jose Contreras
Sergio Ramirez
+1 786 502 4303

AA Medical Research Center

Recruiting

Flint,Michigan,48504,United States

Fayyaz Shah
+1 810 237 1125
Ahmed A Arif

Clinical Trials of Texas

Recruiting

San Antonio,Texas,78229,United States

Libby Knight
+1 210 949 0122
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
+1 702 804 5900
Atoya Adams

Progressive Clinical Research

Recruiting

Bountiful,Utah,84010,United States

Joshua Oaks
Madie Toole
+1 801 292 2850

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
+1 770 407 6369
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

Theresa Hanburry
+1 904 730 0101
Michael J Koren

Cardiology Partners Clinical Research Institute

Recruiting

Wellington,Florida,33449,United States

Elizabeth Dagher
+1 561 537 4778
Duccio Baldari

Capitol Cardiology Associates

Recruiting

Lanham,Maryland,20706,United States

Vineet Venugopal
Iluyomade Adeusi
+1 301 312 0575

Metropolitan Cardiovascular Consultants Llc

Recruiting

Beltsville,Maryland,20705,United States

Nibras Seman
+1 301 595 0356
Ayim Akyea-Djamson

CV Ins of the South

Recruiting

Lafayette,Louisiana,70503,United States

Wade May
Ariel Quebedeaux

AMR Chicago

Recruiting

Oak Brook,Illinois,60523,United States

Saifullah Nasir
Loria Awadallah

Alliance Clinical

Recruiting

Canoga Park,California,91303,United States

Anitha Roobalingam
Hessam Aazami

Dominion Medical Associates

Recruiting

Richmond,Virginia,23219,United States

Richard A Jackson
Adrian Knight
+1 804 836 6540

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

+41613241111

Novartis Pharmaceuticals

1-888-669-6682