Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to determine the safety and efficacy of DII235 in adults with elevated lipoprotein(a).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Placebo Comparator | Placebo |
|
| Arm 2 | Experimental | DII235 dose 1 |
|
| Arm 3 | Experimental | DII235 dose 2 |
|
| Arm 4 | Experimental | DII235 dose 3 |
|
| Arm 5 | Experimental | DII235 dose 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DII235 | Drug | Solution for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to day 60 and day 180 |
| 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. | baseline to day 60 and day 360 |
| 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. | baseline to day 60 and day 360 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to day 60 and 360 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkway Medical Center | Birmingham | Alabama | 35215 | United States | ||
| Heart Center Research Llc |
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In order to preserve the integrity of the study and to minimize bias, a randomized double-blind study design is being used.
| Saline | Drug | solution for injection |
|
| 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. | baseline to day 240 and Day 360 |
| 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. | Day 180 and Day 360 |
| 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. | Day 180 and Day 360 |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Cardiology and Medicine Clinic PA | Little Rock | Arkansas | 72204 | United States |
| National Heart Institute | Beverly Hills | California | 90211 | United States |
| Alliance Clinical | Canoga Park | California | 91303 | United States |
| Excel Medical Clinical Trials LLC | Boca Raton | Florida | 33434 | United States |
| Zenith Clinical Research | Hollywood | Florida | 33021 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Flourish Res Acq LLC North Miami | Miami | Florida | 33138 | United States |
| Inpatient Research Clinical LLC | Miami Lakes | Florida | 33014 | United States |
| Ocala Cardiovascular Research | Ocala | Florida | 34471 | United States |
| SEC Clinical Research | Pensacola | Florida | 32503 | United States |
| Cardiology Partners Clinical Research Institute | Wellington | Florida | 33449 | United States |
| Atlanta Heart Specialists LLC | Tucker | Georgia | 30084 | United States |
| AMR Chicago | Niles | Illinois | 60714 | United States |
| CV Ins of the South | Lafayette | Louisiana | 70503 | United States |
| Monroe Research Llc | West Monroe | Louisiana | 71291 | United States |
| Metropolitan Cardiovascular Consultants Llc | Beltsville | Maryland | 20705 | United States |
| Anderson Medical Research | Ft. Washington | Maryland | 20744 | United States |
| Capitol Cardiology Associates | Lanham | Maryland | 20706 | United States |
| AA Medical Research Center | Flint | Michigan | 48504 | United States |
| Trinity Health Michigan Heart | Ypsilanti | Michigan | 48197 | United States |
| Cardiology Associates of North MS | Tupelo | Mississippi | 38801 | United States |
| AB Clinical Trials | Las Vegas | Nevada | 89119 | United States |
| K and R Research LLC | Marion | Ohio | 43302 | United States |
| TCV Clinical Studies | Linwood | Pennsylvania | 19061 | United States |
| Cardiology Consultants of Philadelphia | Yardley | Pennsylvania | 19067 | United States |
| Apex Cardiology Research Associates of Jackson | Jackson | Tennessee | 38301 | United States |
| Alliance for Multispecialty Research | Knoxville | Tennessee | 37909 | United States |
| Angiocardiac Care of Texas PA | Houston | Texas | 77025 | United States |
| Dallas Heart and Vascular Consultants PA | Houston | Texas | 77084 | United States |
| Biopharma Informatic | Katy | Texas | 77479 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
| Northwest Houston Clinical Research PLLC | Tomball | Texas | 77375 | United States |
| Progressive Clinical Research | Bountiful | Utah | 84010 | United States |
| Dominion Medical Associates | Richmond | Virginia | 23219 | United States |
| MultiCare Ins Research Innovation | Puyallup | Washington | 98372 | 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 |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided