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

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: Active, not recruiting
• Conditions: Lipoprotein Disorder
• Intervention / Treatment: Drug: Saline; Drug: DII235

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Novartis Investigative Site
  • Henan
    • Luoyang, Henan, China, 471002
      • Novartis Investigative Site
  • Liaoning
    • Shenyang, Liaoning, China, 110016
      • Novartis Investigative Site
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Novartis Investigative Site
• Germany
  • Bad Krozingen, Germany, 79189
    • Novartis Investigative Site
  • Bad Oeynhausen, Germany, 32545
    • Novartis Investigative Site
  • Berlin, Germany, 10787
    • Novartis Investigative Site
  • Dortmund, Germany, 44137
    • Novartis Investigative Site
  • Essen, Germany, 45359
    • Novartis Investigative Site
  • Gladbeck, Germany, 45968
    • Novartis Investigative Site
  • Magdeburg, Germany, 39120
    • Novartis Investigative Site
  • Münster, Germany, 48145
    • Novartis Investigative Site
  • Papenburg, Germany, 26871
    • Novartis Investigative Site
  • Rostock, Germany, 18057
    • Novartis Investigative Site
  • Warendorf, Germany, 48231
    • Novartis Investigative Site
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Novartis Investigative Site
  • Brandenburg
    • Potsdam, Brandenburg, Germany, 14473
      • Novartis Investigative Site
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60594
      • Novartis Investigative Site
  • Rhineland-Palatinate
    • Kaiserslautern, Rhineland-Palatinate, Germany, 67655
      • Novartis Investigative Site
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Novartis Investigative Site
• Japan
  • Kyoto, Japan, 6078062
    • Novartis Investigative Site
  • Chiba
    • Matsudo, Chiba, Japan, 270-2251
      • Novartis Investigative Site
  • Kagawa-ken
    • Takamatsu, Kagawa-ken, Japan, 7608557
      • Novartis Investigative Site
  • Miyazaki
    • Miyhazaki, Miyazaki, Japan, 8802102
      • Novartis Investigative Site
  • Osaka
    • Suita, Osaka, Japan, 5650853
      • Novartis Investigative Site
  • Tokyo
    • Shinjuku Ku, Tokyo, Japan, 160-0008
      • Novartis Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35215
      • Parkway Medical Center
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research LLC
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Cardiology and Medicine Clinic PA
  • California
    • Beverly Hills, California, United States, 90211
      • National Heart Institute
    • Canoga Park, California, United States, 91303
      • Alliance Clinical
  • Florida
    • Boca Raton, Florida, United States, 33434
      • Excel Medical Clinical Trials LLC
    • Hollywood, Florida, United States, 33021
      • Zenith Clinical Research
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Miami, Florida, United States, 33138
      • Flourish Res Acq LLC North Miami
    • Miami Lakes, Florida, United States, 33014
      • Inpatient Research Clinical LLC
    • Ocala, Florida, United States, 34471
      • Ocala Cardiovascular Research
    • Pensacola, Florida, United States, 32503
      • SEC Clinical Research
    • Wellington, Florida, United States, 33449
      • Cardiology Partners Clinical Research Institute
  • Georgia
    • Tucker, Georgia, United States, 30084
      • Atlanta Heart Specialists LLC
  • Illinois
    • Niles, Illinois, United States, 60714
      • AMR Chicago
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • CV Ins of the South
    • West Monroe, Louisiana, United States, 71291
      • Monroe Research LLC
  • Maryland
    • Beltsville, Maryland, United States, 20705
      • Metropolitan Cardiovascular Consultants LLC
    • Ft. Washington, Maryland, United States, 20744
      • Anderson Medical Research
    • Lanham, Maryland, United States, 20706
      • Capitol Cardiology Associates
  • Michigan
    • Flint, Michigan, United States, 48504
      • AA Medical Research Center
    • Ypsilanti, Michigan, United States, 48197
      • Trinity Health Michigan Heart
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Cardiology Associates of North MS
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • AB Clinical Trials
  • Ohio
    • Marion, Ohio, United States, 43302
      • K and R Research LLC
  • Pennsylvania
    • Linwood, Pennsylvania, United States, 19061
      • TCV Clinical Studies
    • Yardley, Pennsylvania, United States, 19067
      • Cardiology Consultants of Philadelphia
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Apex Cardiology Research Associates of Jackson
    • Knoxville, Tennessee, United States, 37909
      • Alliance for Multispecialty Research
  • Texas
    • Houston, Texas, United States, 77025
      • Angiocardiac Care of Texas PA
    • Houston, Texas, United States, 77084
      • Dallas Heart and Vascular Consultants PA
    • Katy, Texas, United States, 77479
      • Biopharma Informatic
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas
    • Tomball, Texas, United States, 77375
      • Northwest Houston Clinical Research PLLC
  • Utah
    • Bountiful, Utah, United States, 84010
      • Progressive Clinical Research
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Dominion Medical Associates
  • Washington
    • Puyallup, Washington, United States, 98372
      • MultiCare Ins Research Innovation

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

5

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 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 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 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 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 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	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	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

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2025
• Primary Completion (Estimated): April 26, 2027
• Study Completion (Estimated): April 25, 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): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: cardiovascular disease; Lipoprotein(a); cardiovascular; cholesterol; hyperlipidemia; dyslipidemia; atherosclerotic cardiovascular disease (ASCVD); lipoprotein disorder; DII235
• Additional Relevant MeSH Terms: Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Nutritional and Metabolic Diseases; Cardiovascular Diseases; Dyslipidemias; Atherosclerosis; Hyperlipidemias; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• 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