Clinical Trials in Japan / NCT07235046
Active, not recruiting
Phase 2
A Study of DII235 in Adults With Elevated Lipoprotein(a)
NCT07235046 · tracked via the Priya Life Science Japan tracker
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
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 | Status |
|---|---|---|---|
| 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.
More Novartis Pharmaceuticals trials in Japan
Other trials for the same condition
Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)
Active, not 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 Japan