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)
1 other identifier
interventional
200
4 countries
66
Brief Summary
The main purpose of this study is to determine the safety and efficacy of DII235 in adults with elevated lipoprotein(a).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2025
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2025
CompletedFirst Posted
Study publicly available on registry
November 19, 2025
CompletedStudy Start
First participant enrolled
December 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 25, 2028
June 8, 2026
June 1, 2026
1.4 years
November 14, 2025
June 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
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
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
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
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
Day 180 and Day 360
Study Arms (5)
Arm 1
PLACEBO COMPARATORPlacebo
Arm 2
EXPERIMENTALDII235 dose 1
Arm 3
EXPERIMENTALDII235 dose 2
Arm 4
EXPERIMENTALDII235 dose 3
Arm 5
EXPERIMENTALDII235 dose 4
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
Parkway Medical Center
Birmingham, Alabama, 35215, United States
Heart Center Research Llc
Huntsville, Alabama, 35801, United States
Cardiology and Medicine Clinic PA
Little Rock, Arkansas, 72204, United States
National Heart Institute
Beverly Hills, California, 90211, United States
Alliance Clinical
Canoga Park, California, 91303, United States
Excel Medical Clinical Trials LLC
Boca Raton, Florida, 33434, United States
Zenith Clinical Research
Hollywood, Florida, 33021, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Flourish Res Acq LLC North Miami
Miami, Florida, 33138, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014, United States
Ocala Cardiovascular Research
Ocala, Florida, 34471, United States
SEC Clinical Research
Pensacola, Florida, 32503, United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449, United States
Atlanta Heart Specialists LLC
Tucker, Georgia, 30084, United States
AMR Chicago
Niles, Illinois, 60714, United States
CV Ins of the South
Lafayette, Louisiana, 70503, United States
Monroe Research Llc
West Monroe, Louisiana, 71291, United States
Metropolitan Cardiovascular Consultants Llc
Beltsville, Maryland, 20705, United States
Anderson Medical Research
Ft. Washington, Maryland, 20744, United States
Capitol Cardiology Associates
Lanham, Maryland, 20706, United States
AA Medical Research Center
Flint, Michigan, 48504, United States
Trinity Health Michigan Heart
Ypsilanti, Michigan, 48197, United States
Cardiology Associates of North MS
Tupelo, Mississippi, 38801, United States
AB Clinical Trials
Las Vegas, Nevada, 89119, United States
K and R Research LLC
Marion, Ohio, 43302, United States
TCV Clinical Studies
Linwood, Pennsylvania, 19061, United States
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, 19067, United States
Apex Cardiology Research Associates of Jackson
Jackson, Tennessee, 38301, United States
Alliance for Multispecialty Research
Knoxville, Tennessee, 37909, United States
Angiocardiac Care of Texas PA
Houston, Texas, 77025, United States
Dallas Heart and Vascular Consultants PA
Houston, Texas, 77084, United States
Biopharma Informatic
Katy, Texas, 77479, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Northwest Houston Clinical Research PLLC
Tomball, Texas, 77375, United States
Progressive Clinical Research
Bountiful, Utah, 84010, United States
Dominion Medical Associates
Richmond, Virginia, 23219, United States
MultiCare Ins Research Innovation
Puyallup, Washington, 98372, United States
Novartis Investigative Site
Luoyang, Henan, 471002, China
Novartis Investigative Site
Shenyang, Liaoning, 110016, China
Novartis Investigative Site
Wenzhou, Zhejiang, 325000, China
Novartis Investigative Site
Beijing, 100034, China
Novartis Investigative Site
Munich, Bavaria, 81377, Germany
Novartis Investigative Site
Potsdam, Brandenburg, 14473, Germany
Novartis Investigative Site
Frankfurt am Main, Hesse, 60594, Germany
Novartis Investigative Site
Kaiserslautern, Rhineland-Palatinate, 67655, Germany
Novartis Investigative Site
Dresden, Saxony, 01307, Germany
Novartis Investigative Site
Bad Krozingen, 79189, Germany
Novartis Investigative Site
Bad Oeynhausen, 32545, Germany
Novartis Investigative Site
Berlin, 10787, Germany
Novartis Investigative Site
Dortmund, 44137, Germany
Novartis Investigative Site
Essen, 45147, Germany
Novartis Investigative Site
Essen, 45359, Germany
Novartis Investigative Site
Gladbeck, 45968, Germany
Novartis Investigative Site
Magdeburg, 39120, Germany
Novartis Investigative Site
Münster, 48145, Germany
Novartis Investigative Site
Papenburg, 26871, Germany
Novartis Investigative Site
Rostock, 18057, Germany
Novartis Investigative Site
Rüdersdorf, 15562, Germany
Novartis Investigative Site
Warendorf, 48231, Germany
Novartis Investigative Site
Matsudo, Chiba, 270-2251, Japan
Novartis Investigative Site
Takamatsu, Kagawa-ken, 7608557, Japan
Novartis Investigative Site
Miyhazaki, Miyazaki, 8802102, Japan
Novartis Investigative Site
Suita, Osaka, 5650853, Japan
Novartis Investigative Site
Shinjuku Ku, Tokyo, 160-0008, Japan
Novartis Investigative Site
Kyoto, 6078062, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- In order to preserve the integrity of the study and to minimize bias, a randomized double-blind study design is being used.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2025
First Posted
November 19, 2025
Study Start
December 2, 2025
Primary Completion (Estimated)
April 26, 2027
Study Completion (Estimated)
April 25, 2028
Last Updated
June 8, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
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