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

April 9, 2026 updated by: Novartis Pharmaceuticals

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • China
      • Beijing, China, 100034
        • Recruiting
        • Novartis Investigative Site
    • Henan
      • Luoyang, Henan, China, 471002
        • Active, not recruiting
        • Novartis Investigative Site
    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • Recruiting
        • Novartis Investigative Site
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Active, not recruiting
        • Novartis Investigative Site
  • Germany
      • Bad Krozingen, Germany, 79189
        • Recruiting
        • Novartis Investigative Site
      • Bad Oeynhausen, Germany, 32545
        • Recruiting
        • Novartis Investigative Site
      • Berlin, Germany, 10787
        • Recruiting
        • Novartis Investigative Site
      • Dortmund, Germany, 44137
        • Recruiting
        • Novartis Investigative Site
      • Essen, Germany, 45147
        • Recruiting
        • Novartis Investigative Site
      • Essen, Germany, 45359
        • Recruiting
        • Novartis Investigative Site
      • Gladbeck, Germany, 45968
        • Recruiting
        • Novartis Investigative Site
      • Magdeburg, Germany, 39120
        • Recruiting
        • Novartis Investigative Site
      • Münster, Germany, 48145
        • Recruiting
        • Novartis Investigative Site
      • Papenburg, Germany, 26871
        • Recruiting
        • Novartis Investigative Site
      • Rostock, Germany, 18057
        • Recruiting
        • Novartis Investigative Site
      • Rüdersdorf, Germany, 15562
        • Recruiting
        • Novartis Investigative Site
      • Warendorf, Germany, 48231
        • Recruiting
        • Novartis Investigative Site
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Recruiting
        • Novartis Investigative Site
    • Brandenburg
      • Potsdam, Brandenburg, Germany, 14473
        • Recruiting
        • Novartis Investigative Site
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60594
        • Recruiting
        • Novartis Investigative Site
    • Rhineland-Palatinate
      • Kaiserslautern, Rhineland-Palatinate, Germany, 67655
        • Recruiting
        • Novartis Investigative Site
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • Novartis Investigative Site
  • Japan
      • Kyoto, Japan, 6078062
        • Recruiting
        • Novartis Investigative Site
    • Chiba
      • Matsudo, Chiba, Japan, 270-2251
        • Recruiting
        • Novartis Investigative Site
    • Kagawa-ken
      • Takamatsu, Kagawa-ken, Japan, 760 8557
        • Recruiting
        • Novartis Investigative Site
    • Miyazaki
      • Miyhazaki, Miyazaki, Japan, 8802102
        • Recruiting
        • Novartis Investigative Site
    • Osaka
      • Suita, Osaka, Japan, 5650853
        • Recruiting
        • Novartis Investigative Site
    • Tokyo
      • Shinjuku Ku, Tokyo, Japan, 160-0008
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Recruiting
        • Parkway Medical Center
        • Principal Investigator:
          • James Sullivan
        • Contact:
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • Heart Center Research LLC
        • Principal Investigator:
          • Vernon R Hunter
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • Cardiology and Medicine Clinic PA
        • Principal Investigator:
          • Joe L Hargrove
        • Contact:
    • California
      • Beverly Hills, California, United States, 90211
      • Canoga Park, California, United States, 91303
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Recruiting
        • Excel Medical Clinical Trials LLC
        • Principal Investigator:
          • Rasha Youssef
        • Contact:
      • Hollywood, Florida, United States, 33021
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Jacksonville Center for Clinical Research
        • Principal Investigator:
          • Michael J Koren
        • Contact:
      • Miami, Florida, United States, 33138
        • Recruiting
        • Flourish Res Acq LLC North Miami
        • Principal Investigator:
          • Rimsky Denis
        • Contact:
      • Miami Lakes, Florida, United States, 33014
      • Ocala, Florida, United States, 34471
        • Active, not recruiting
        • Ocala Cardiovascular Research
      • Pensacola, Florida, United States, 32503
        • Recruiting
        • SEC Clinical Research
        • Contact:
        • Principal Investigator:
          • William Doty
      • Wellington, Florida, United States, 33449
    • Georgia
      • Tucker, Georgia, United States, 30084
        • Recruiting
        • Atlanta Heart Specialists LLC
        • Principal Investigator:
          • David Suh
        • Contact:
    • Illinois
      • Oak Brook, Illinois, United States, 60523
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
      • West Monroe, Louisiana, United States, 71291
    • Maryland
      • Beltsville, Maryland, United States, 20705
        • Recruiting
        • Metropolitan Cardiovascular Consultants LLC
        • Principal Investigator:
          • Ayim Akyea-Djamson
        • Contact:
      • Ft. Washington, Maryland, United States, 20744
      • Lanham, Maryland, United States, 20706
        • Recruiting
        • Capitol Cardiology Associates
        • Principal Investigator:
          • Vineet Venugopal
        • Contact:
    • Michigan
      • Flint, Michigan, United States, 48504
        • Recruiting
        • AA Medical Research Center
        • Principal Investigator:
          • Ahmed A Arif
        • Contact:
      • Ypsilanti, Michigan, United States, 48197
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Recruiting
        • Cardiology Associates of North MS
        • Contact:
        • Principal Investigator:
          • Henry Baker Boler
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Recruiting
        • AB Clinical Trials
        • Principal Investigator:
          • Atoya Adams
        • Contact:
    • Ohio
      • Marion, Ohio, United States, 43302
        • Recruiting
        • K and R Research LLC
        • Principal Investigator:
          • Parminder Singh
        • Contact:
    • Pennsylvania
      • Linwood, Pennsylvania, United States, 19061
        • Active, not recruiting
        • TCV Clinical Studies
      • Yardley, Pennsylvania, United States, 19067
        • Active, not recruiting
        • Cardiology Consultants of Philadelphia
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • Recruiting
        • Apex Cardiology Research Associates of Jackson
        • Principal Investigator:
          • Mohsin Alhaddad
        • Contact:
      • Knoxville, Tennessee, United States, 37909
    • Texas
      • Houston, Texas, United States, 77025
        • Recruiting
        • Angiocardiac Care of Texas PA
        • Principal Investigator:
          • Amin Karim
        • Contact:
      • Houston, Texas, United States, 77084
        • Recruiting
        • Dallas Heart and Vascular Consultants PA
        • Principal Investigator:
          • Imran Afridi
        • Contact:
      • Katy, Texas, United States, 77479
        • Recruiting
        • Biopharma Informatic
        • Principal Investigator:
          • Syed Humayun Naqvi
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Clinical Trials of Texas
        • Principal Investigator:
          • Douglas Denham
        • Contact:
      • Tomball, Texas, United States, 77375
        • Recruiting
        • Northwest Houston Clinical Research PLLC
        • Principal Investigator:
          • Shamaila Aslam
        • Contact:
    • Utah
      • Bountiful, Utah, United States, 84010
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Dominion Medical Associates
        • Principal Investigator:
          • Richard A Jackson
        • Contact:
    • Washington
      • Puyallup, Washington, United States, 98372
        • Recruiting
        • MultiCare Ins Research Innovation
        • Principal Investigator:
          • Vinay Malhotra
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm 1
Placebo
Drug: Saline
solution for injection
Experimental: Arm 2
DII235 dose 1
Drug: DII235
Solution for injection
Experimental: Arm 3
DII235 dose 2
Drug: DII235
Solution for injection
Experimental: Arm 4
DII235 dose 3
Drug: DII235
Solution for injection
Experimental: Arm 5
DII235 dose 4
Drug: DII235
Solution for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time averaged percentage change from baseline between Day 60 and Day 180
Time Frame: baseline 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.
baseline to day 60 and day 180
Difference between DII235 dose 2 and placebo in time-averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360
Time Frame: baseline 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.
baseline to day 60 and day 360
Difference between DII235 dose 4 and placebo in time-averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360
Time Frame: baseline 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.
baseline to day 60 and day 360

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between DII235 dose 1, dose 3 and placebo versus placebo in time-averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360
Time Frame: baseline to day 60 and 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.
baseline to day 60 and 360
Difference between DII235 doses versus placebo in time-averaged percent change from baseline in Lp(a) measured between Day 240 and Day 360
Time Frame: baseline to day 240 and Day 360
Time averaged change from baseline in log Lp(a) measured between Day 240 and Day 360, defined as the area under the curve (AUC) between the Day 240 Visit date and the Day 360 Visit date, divided by the duration between the two visit dates.
baseline to day 240 and Day 360
Difference between DII235 doses versus placebo with respect to the proportion of participants in achieving Lp(a) < 125 nmol/L at Day 180 and Day 360
Time Frame: Day 180 and Day 360
Participant's status of achieving Lp(a) < 125 nmol/L at Day 180 and at Day 360 (Yes, No), without having any defined intercurrent events.
Day 180 and Day 360
Difference between DII235 doses versus placebo with respect to the proportion of participants in achieving Lp(a) < 75 nmol/L at Day 180 and Day 360
Time Frame: Day 180 and Day 360
Participant's status of achieving Lp(a) < 75 nmol/L at Day 180 and at Day 360 (Yes, No), without having any defined intercurrent events.
Day 180 and Day 360

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2025

Primary Completion (Estimated)

September 8, 2027

Study Completion (Estimated)

September 8, 2028

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDII235A12201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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