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Lipoprotein DisorderPhase 2NCT07235046

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

A Phase 2 study testing DII235 and Saline in people with Lipoprotein Disorder, run by Novartis Pharmaceuticals at 63 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Lipoprotein Disorder
What is being tested?
DII235 and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
234 participants
Where
63 sitesin 4 countries
Study dates
2 Dec 2025to 25 Apr 2028
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

63 sites in 4 countries.

63 sites in 4 countries

United States37 sites

  • Metropolitan Cardiovascular Consultants Llc

    Beltsville, Maryland, 20705

  • National Heart Institute

    Beverly Hills, California, 90211

  • Parkway Medical Center

    Birmingham, Alabama, 35215

  • Excel Medical Clinical Trials LLC

    Boca Raton, Florida, 33434

  • Progressive Clinical Research

    Bountiful, Utah, 84010

  • Alliance Clinical

    Canoga Park, California, 91303

  • AA Medical Research Center

    Flint, Michigan, 48504

  • Anderson Medical Research

    Ft. Washington, Maryland, 20744

  • Zenith Clinical Research

    Hollywood, Florida, 33021

  • Angiocardiac Care of Texas PA

    Houston, Texas, 77025

  • Dallas Heart and Vascular Consultants PA

    Houston, Texas, 77084

  • Heart Center Research Llc

    Huntsville, Alabama, 35801

  • Apex Cardiology Research Associates of Jackson

    Jackson, Tennessee, 38301

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Biopharma Informatic

    Katy, Texas, 77479

  • Alliance for Multispecialty Research

    Knoxville, Tennessee, 37909

  • CV Ins of the South

    Lafayette, Louisiana, 70503

  • Capitol Cardiology Associates

    Lanham, Maryland, 20706

  • AB Clinical Trials

    Las Vegas, Nevada, 89119

  • TCV Clinical Studies

    Linwood, Pennsylvania, 19061

  • Cardiology and Medicine Clinic PA

    Little Rock, Arkansas, 72204

  • K and R Research LLC

    Marion, Ohio, 43302

  • Flourish Res Acq LLC North Miami

    Miami, Florida, 33138

  • Inpatient Research Clinical LLC

    Miami Lakes, Florida, 33014

  • AMR Chicago

    Niles, Illinois, 60714

  • Ocala Cardiovascular Research

    Ocala, Florida, 34471

  • SEC Clinical Research

    Pensacola, Florida, 32503

  • MultiCare Ins Research Innovation

    Puyallup, Washington, 98372

  • Dominion Medical Associates

    Richmond, Virginia, 23219

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

  • Northwest Houston Clinical Research PLLC

    Tomball, Texas, 77375

  • Atlanta Heart Specialists LLC

    Tucker, Georgia, 30084

  • Cardiology Associates of North MS

    Tupelo, Mississippi, 38801

  • Cardiology Partners Clinical Research Institute

    Wellington, Florida, 33449

  • Monroe Research Llc

    West Monroe, Louisiana, 71291

  • Cardiology Consultants of Philadelphia

    Yardley, Pennsylvania, 19067

  • Trinity Health Michigan Heart

    Ypsilanti, Michigan, 48197

Other trials in United States

Germany16 sites

  • Novartis Investigative Site

    Bad Krozingen, 79189

  • Novartis Investigative Site

    Bad Oeynhausen, 32545

  • Novartis Investigative Site

    Berlin, 10787

  • Novartis Investigative Site

    Dortmund, 44137

  • Novartis Investigative Site

    Dresden, Saxony, 01307

  • Novartis Investigative Site

    Essen, 45359

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60594

  • Novartis Investigative Site

    Gladbeck, 45968

  • Novartis Investigative Site

    Kaiserslautern, Rhineland-Palatinate, 67655

  • Novartis Investigative Site

    Magdeburg, 39120

  • Novartis Investigative Site

    Munich, Bavaria, 81377

  • Novartis Investigative Site

    Münster, 48145

  • Novartis Investigative Site

    Papenburg, 26871

  • Novartis Investigative Site

    Potsdam, Brandenburg, 14473

  • Novartis Investigative Site

    Rostock, 18057

  • Novartis Investigative Site

    Warendorf, 48231

Other trials in Germany

Japan6 sites

  • Novartis Investigative Site

    Kyoto, 6078062

  • Novartis Investigative Site

    Matsudo, Chiba, 270-2251

  • Novartis Investigative Site

    Miyhazaki, Miyazaki, 8802102

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 160-0008

  • Novartis Investigative Site

    Suita, Osaka, 5650853

  • Novartis Investigative Site

    Takamatsu, Kagawa-ken, 7608557

Other trials in Japan

China4 sites

  • Novartis Investigative Site

    Beijing, 100034

  • Novartis Investigative Site

    Luoyang, Henan, 471002

  • Novartis Investigative Site

    Shenyang, Liaoning, 110016

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325000

Other trials in China

About this study

Official title: 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).

Being tested
DII235, Saline
Keywords
Lipoprotein(a), cardiovascular disease, atherosclerotic cardiovascular disease (ASCVD), lipoprotein disorder, cardiovascular, cholesterol, hyperlipidemia, dyslipidemia, DII235
Medical subject headings
Cardiovascular Diseases, Atherosclerosis, Hyperlipidemias, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DII235Drug

    Solution for injection

  • SalineDrug

    solution for injection

Study groups in NCT07235046
Study groupRoleWhat they receive
Arm 1Placebo comparatorPlacebo
Receives: Drug: Saline
Arm 2ExperimentalDII235 dose 1
Receives: Drug: DII235
Arm 3ExperimentalDII235 dose 2
Receives: Drug: DII235
Arm 4ExperimentalDII235 dose 3
Receives: Drug: DII235
Arm 5ExperimentalDII235 dose 4
Receives: Drug: DII235

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline to day 60 and day 180

  2. 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.

    Measured: baseline to day 60 and day 360

  3. 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.

    Measured: baseline to day 60 and day 360

Secondary outcomes (4)

  1. 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.

    Measured: baseline to day 60 and 360

  2. 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.

    Measured: baseline to day 240 and Day 360

  3. 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.

    Measured: Day 180 and Day 360

  4. 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.

    Measured: Day 180 and Day 360

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2025
  2. Study start2 Dec 2025
  3. Primary completion26 Apr 2027 (estimated)
  4. Study completion25 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07235046
Sponsor's protocol ID
CDII235A12201
Status last verified
Jul 2026
First submitted
14 Nov 2025
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

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