A Study of DII235 in Adults With Elevated Lipoprotein(a)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT07235046
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Lipoprotein Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- DII235 — DRUGSolution for injection
- Saline — DRUGsolution for injection
Study Details
The main purpose of this study is to determine the safety and efficacy of DII235 in adults with elevated lipoprotein(a).
Key Dates
- Start date
- Dec 2, 2025
- Status verified
- Jun 2026
- Primary completion
- Apr 26, 2027
- Completion
- Apr 25, 2028
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Arm 1Placebo
- Experimental: Arm 2DII235 dose 1
- Experimental: Arm 3DII235 dose 2
- Experimental: Arm 4DII235 dose 3
- Experimental: Arm 5DII235 dose 4
Primary Outcome Measure
Time averaged percentage change from baseline between Day 60 and Day 180 [ Time Frame: baseline to day 60 and day 180 ]
Central Contacts
- Novartis Pharmaceuticals1-888-669-6682
- Novartis Pharmaceuticals+41613241111
Locations (38)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Parkway Medical Center | Birmingham | Alabama | 35215 | James Sullivan (PRINCIPAL_INVESTIGATOR) |
| Heart Center Research Llc | Huntsville | Alabama | 35801 | Amy Williams Vernon R Hunter (PRINCIPAL_INVESTIGATOR) |
| Cardiology and Medicine Clinic PA | Little Rock | Arkansas | 72204 | - |
| National Heart Institute | Beverly Hills | California | 90211 | Norman Lepor (PRINCIPAL_INVESTIGATOR) |
| Alliance Clinical | Canoga Park | California | 91303 | Anitha Roobalingam Hessam Aazami (PRINCIPAL_INVESTIGATOR) |
| Excel Medical Clinical Trials LLC | Boca Raton | Florida | 33434 | - |
| Zenith Clinical Research | Hollywood | Florida | 33021 | - |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | Michael J Koren (PRINCIPAL_INVESTIGATOR) |
| Flourish Res Acq LLC North Miami | Miami | Florida | 33138 | - |
| Inpatient Research Clinical LLC | Miami Lakes | Florida | 33014 | Alexis Gutierrez (PRINCIPAL_INVESTIGATOR) |
| Inpatient Research Clinical LLC | Miami Lakes | Florida | 33014 | - |
| Ocala Cardiovascular Research | Ocala | Florida | 34471 | - |
| SEC Clinical Research | Pensacola | Florida | 32503 | William Doty (PRINCIPAL_INVESTIGATOR) |
| Cardiology Partners Clinical Research Institute | Wellington | Florida | 33449 | - |
| Atlanta Heart Specialists LLC | Tucker | Georgia | 30084 | David Suh (PRINCIPAL_INVESTIGATOR) |
| AMR Chicago | Niles | Illinois | 60714 | Loria Awadallah Saifullah Nasir (PRINCIPAL_INVESTIGATOR) |
| CV Ins of the South | Lafayette | Louisiana | 70503 | Ariel Quebedeaux Wade May (PRINCIPAL_INVESTIGATOR) |
| Monroe Research Llc | West Monroe | Louisiana | 71291 | Assad Mouhaffel (PRINCIPAL_INVESTIGATOR) |
| Metropolitan Cardiovascular Consultants Llc | Beltsville | Maryland | 20705 | Ayim Akyea-Djamson (PRINCIPAL_INVESTIGATOR) |
| Anderson Medical Research | Ft. Washington | Maryland | 20744 | Ann-Marie Cobb Felton Anderson (PRINCIPAL_INVESTIGATOR) |
| Capitol Cardiology Associates | Lanham | Maryland | 20706 | Vineet Venugopal (PRINCIPAL_INVESTIGATOR) |
| AA Medical Research Center | Flint | Michigan | 48504 | Ahmed A Arif (PRINCIPAL_INVESTIGATOR) |
| Trinity Health Michigan Heart | Ypsilanti | Michigan | 48197 | Martha Bohn Ahmad Mizyed (PRINCIPAL_INVESTIGATOR) |
| Cardiology Associates of North MS | Tupelo | Mississippi | 38801 | Brittany Cook Henry Baker Boler (PRINCIPAL_INVESTIGATOR) |
| AB Clinical Trials | Las Vegas | Nevada | 89119 | Atoya Adams (PRINCIPAL_INVESTIGATOR) |
| K and R Research LLC | Marion | Ohio | 43302 | Rhonda Rudd Parminder Singh (PRINCIPAL_INVESTIGATOR) |
| TCV Clinical Studies | Linwood | Pennsylvania | 19061 | - |
| Cardiology Consultants of Philadelphia | Yardley | Pennsylvania | 19067 | - |
| Apex Cardiology Research Associates of Jackson | Jackson | Tennessee | 38301 | Mohsin Alhaddad (PRINCIPAL_INVESTIGATOR) |
| Alliance for Multispecialty Research | Knoxville | Tennessee | 37909 | Shaunacie Mc Callum Jerry Punch (PRINCIPAL_INVESTIGATOR) |
| Angiocardiac Care of Texas PA | Houston | Texas | 77025 | - |
| Dallas Heart and Vascular Consultants PA | Houston | Texas | 77084 | - |
| Biopharma Informatic | Katy | Texas | 77479 | - |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | - |
| Northwest Houston Clinical Research PLLC | Tomball | Texas | 77375 | - |
| Progressive Clinical Research | Bountiful | Utah | 84010 | - |
| Dominion Medical Associates | Richmond | Virginia | 23219 | - |
| MultiCare Ins Research Innovation | Puyallup | Washington | 98372 | Vinay Malhotra (PRINCIPAL_INVESTIGATOR) |