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New shot aims to tackle hidden heart risk: high lp(a)

NCT ID NCT07235046

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This phase 2 trial tests an injectable drug called DII235 in 233 adults with high lipoprotein(a), a genetic condition that raises heart disease and stroke risk. Participants have heart disease or type 2 diabetes. The study compares different doses of DII235 against a placebo to see if it safely lowers Lp(a) levels over several months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DII235 (an injectable drug)
What this could lead to
If successful, this could lead to a new treatment to lower high lipoprotein(a), a genetic risk factor for heart disease and stroke.
What could go wrong
This is a mid-stage trial with only 233 participants, so results may not apply to everyone. The drug may not work as hoped or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

234 people

The number who actually took part.

Started

Dec 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atherosclerosis cardiovascular disorder Dyslipidemias hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lipoprotein disorder

Contacts and locations

Locations

  • AA Medical Research Center

    Flint, Michigan, 48504, United States

  • AB Clinical Trials

    Las Vegas, Nevada, 89119, United States

  • AMR Chicago

    Niles, Illinois, 60714, United States

  • Alliance Clinical

    Canoga Park, California, 91303, United States

  • Alliance for Multispecialty Research

    Knoxville, Tennessee, 37909, United States

  • Anderson Medical Research

    Ft. Washington, Maryland, 20744, United States

  • Angiocardiac Care of Texas PA

    Houston, Texas, 77025, United States

  • Apex Cardiology Research Associates of Jackson

    Jackson, Tennessee, 38301, United States

  • Atlanta Heart Specialists LLC

    Tucker, Georgia, 30084, United States

  • Biopharma Informatic

    Katy, Texas, 77479, United States

  • CV Ins of the South

    Lafayette, Louisiana, 70503, United States

  • Capitol Cardiology Associates

    Lanham, Maryland, 20706, United States

  • Cardiology Associates of North MS

    Tupelo, Mississippi, 38801, United States

  • Cardiology Consultants of Philadelphia

    Yardley, Pennsylvania, 19067, United States

  • Cardiology Partners Clinical Research Institute

    Wellington, Florida, 33449, United States

  • Cardiology and Medicine Clinic PA

    Little Rock, Arkansas, 72204, United States

  • Clinical Trials of Texas

    San Antonio, Texas, 78229, United States

  • Dallas Heart and Vascular Consultants PA

    Houston, Texas, 77084, United States

  • Dominion Medical Associates

    Richmond, Virginia, 23219, United States

  • Excel Medical Clinical Trials LLC

    Boca Raton, Florida, 33434, United States

  • Flourish Res Acq LLC North Miami

    Miami, Florida, 33138, United States

  • Heart Center Research Llc

    Huntsville, Alabama, 35801, United States

  • Inpatient Research Clinical LLC

    Miami Lakes, Florida, 33014, United States

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216, United States

  • K and R Research LLC

    Marion, Ohio, 43302, United States

  • Metropolitan Cardiovascular Consultants Llc

    Beltsville, Maryland, 20705, United States

  • Monroe Research Llc

    West Monroe, Louisiana, 71291, United States

  • MultiCare Ins Research Innovation

    Puyallup, Washington, 98372, United States

  • National Heart Institute

    Beverly Hills, California, 90211, United States

  • Northwest Houston Clinical Research PLLC

    Tomball, Texas, 77375, 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, 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

    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

  • Ocala Cardiovascular Research

    Ocala, Florida, 34471, United States

  • Parkway Medical Center

    Birmingham, Alabama, 35215, United States

  • Progressive Clinical Research

    Bountiful, Utah, 84010, United States

  • SEC Clinical Research

    Pensacola, Florida, 32503, United States

  • TCV Clinical Studies

    Linwood, Pennsylvania, 19061, United States

  • Trinity Health Michigan Heart

    Ypsilanti, Michigan, 48197, United States

  • Zenith Clinical Research

    Hollywood, Florida, 33021, United States

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