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

NCT07235046 · tracked via the Priya Life Science China tracker

Sponsor

Novartis Pharmaceuticals

Phase

Phase 2

Started

2025-12-02

Last updated

2026-08-07

Condition(s) studied

Lipoprotein Disorder

Investigational drug(s) / intervention(s)

DII235Saline

DII235: Solution for injection

Saline: solution for injection

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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

Primary outcome measure(s)

Time averaged percentage change from baseline between Day 60 and Day 180 — 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.
Difference between DII235 dose 2 and placebo in time-averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360 — 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.
Difference between DII235 dose 4 and placebo in time-averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360 — 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.

Trial sites (63)

Facility	City	Region
Parkway Medical Center	Birmingham	Alabama
Heart Center Research Llc	Huntsville	Alabama
Cardiology and Medicine Clinic PA	Little Rock	Arkansas
National Heart Institute	Beverly Hills	California
Alliance Clinical	Canoga Park	California
Excel Medical Clinical Trials LLC	Boca Raton	Florida
Zenith Clinical Research	Hollywood	Florida
Jacksonville Center for Clinical Research	Jacksonville	Florida
Flourish Res Acq LLC North Miami	Miami	Florida
Inpatient Research Clinical LLC	Miami Lakes	Florida
Ocala Cardiovascular Research	Ocala	Florida
SEC Clinical Research	Pensacola	Florida
Cardiology Partners Clinical Research Institute	Wellington	Florida
Atlanta Heart Specialists LLC	Tucker	Georgia
AMR Chicago	Niles	Illinois
CV Ins of the South	Lafayette	Louisiana
Monroe Research Llc	West Monroe	Louisiana
Metropolitan Cardiovascular Consultants Llc	Beltsville	Maryland
Anderson Medical Research	Ft. Washington	Maryland
Capitol Cardiology Associates	Lanham	Maryland
AA Medical Research Center	Flint	Michigan
Trinity Health Michigan Heart	Ypsilanti	Michigan
Cardiology Associates of North MS	Tupelo	Mississippi
AB Clinical Trials	Las Vegas	Nevada
K and R Research LLC	Marion	Ohio
TCV Clinical Studies	Linwood	Pennsylvania
Cardiology Consultants of Philadelphia	Yardley	Pennsylvania
Apex Cardiology Research Associates of Jackson	Jackson	Tennessee
Alliance for Multispecialty Research	Knoxville	Tennessee
Angiocardiac Care of Texas PA	Houston	Texas
Dallas Heart and Vascular Consultants PA	Houston	Texas
Biopharma Informatic	Katy	Texas
Clinical Trials of Texas	San Antonio	Texas
Northwest Houston Clinical Research PLLC	Tomball	Texas
Progressive Clinical Research	Bountiful	Utah
Dominion Medical Associates	Richmond	Virginia
MultiCare Ins Research Innovation	Puyallup	Washington
Novartis Investigative Site	Luoyang	Henan
Novartis Investigative Site	Shenyang	Liaoning
Novartis Investigative Site	Wenzhou	Zhejiang

+ 23 more sites — see the full list on the official registry below.

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Other trials for the same condition

Phase I Clinical Study Evaluating the Relative Bioavailability of Different Formulations of HRS-5346 in Healthy Participants Starting soon

A Study of HRS-5632 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events Active, not recruiting

Study of Oral HRS-5346 in Adult Patients With Elevated Lipoprotein(a) and High Risk of Cardiovascular Events Starting soon

Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07235046 on ClinicalTrials.gov ↗ ← All trials in China