Actively Recruiting
A Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-finding Study of DII235 in Adults With Elevated Lipoprotein(a)
Led by Novartis Pharmaceuticals · Updated on 2026-06-08
200
Participants Needed
66
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effects of a drug called DII235 in adults who have high levels of lipoprotein(a), a factor linked to heart disease and diabetes. This study is a Phase 2, randomized, double-blind trial aiming to find the best dose and to understand how DII235 affects lipoprotein(a) levels over time compared to a placebo. Participants will be randomly assigned to one of five groups: four groups receiving different doses of DII235 and one group receiving a placebo (saline solution). The drug is given as an injection. The study will monitor participants from the start through Day 360, measuring changes in lipoprotein(a) levels at several points, especially between Day 60 and Day 360. During the study, participants will have regular assessments including blood tests to measure lipoprotein(a) levels, safety evaluations, and tolerability checks. Researchers will observe the percentage change in lipoprotein(a) from baseline and the proportion of participants reaching certain target levels. The study duration per participant will cover at least 180 to 360 days, with careful monitoring for any side effects or safety concerns throughout.
CONDITIONS
Brief Title
A Study of DII235 in Adults With Elevated Lipoprotein(a)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before joining the study
- Male or female aged 18 to 80 years at screening
- Lipoprotein(a) level of 150 nmol/L or higher at screening
- Have atherosclerotic cardiovascular disease and/or type 2 diabetes mellitus
You will not qualify if you...
- Severe kidney problems
- Liver dysfunction
- Cancer within the last 5 years
- Use of investigational medications as defined in the protocol
- Any medical, surgical, physical, psychiatric, or underlying condition that could affect safety or study participation as judged by the Investigator or sponsor
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 360 days
Participants receive injections of DII235 or placebo to evaluate the effect on Lipoprotein(a) levels.
Visits occur at baseline, Day 60, Day 180, Day 240, and Day 360
Trial Site Locations
Total: 66 locations
1
Parkway Medical Center
Birmingham, Alabama, United States, 35215
Actively Recruiting
2
Heart Center Research Llc
Huntsville, Alabama, United States, 35801
Actively Recruiting
3
Cardiology and Medicine Clinic PA
Little Rock, Arkansas, United States, 72204
Active, Not Recruiting
4
National Heart Institute
Beverly Hills, California, United States, 90211
Actively Recruiting
5
Alliance Clinical
Canoga Park, California, United States, 91303
Actively Recruiting
6
Excel Medical Clinical Trials LLC
Boca Raton, Florida, United States, 33434
Active, Not Recruiting
7
Zenith Clinical Research
Hollywood, Florida, United States, 33021
Active, Not Recruiting
8
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Actively Recruiting
9
Flourish Res Acq LLC North Miami
Miami, Florida, United States, 33138
Active, Not Recruiting
10
Inpatient Research Clinical LLC
Miami Lakes, Florida, United States, 33014
Actively Recruiting
11
Inpatient Research Clinical LLC
Miami Lakes, Florida, United States, 33014
Active, Not Recruiting
12
Ocala Cardiovascular Research
Ocala, Florida, United States, 34471
Active, Not Recruiting
13
SEC Clinical Research
Pensacola, Florida, United States, 32503
Actively Recruiting
14
Cardiology Partners Clinical Research Institute
Wellington, Florida, United States, 33449
Active, Not Recruiting
15
Atlanta Heart Specialists LLC
Tucker, Georgia, United States, 30084
Actively Recruiting
16
AMR Chicago
Niles, Illinois, United States, 60714
Actively Recruiting
17
CV Ins of the South
Lafayette, Louisiana, United States, 70503
Actively Recruiting
18
Monroe Research Llc
West Monroe, Louisiana, United States, 71291
Actively Recruiting
19
Metropolitan Cardiovascular Consultants Llc
Beltsville, Maryland, United States, 20705
Actively Recruiting
20
Anderson Medical Research
Ft. Washington, Maryland, United States, 20744
Actively Recruiting
21
Capitol Cardiology Associates
Lanham, Maryland, United States, 20706
Actively Recruiting
22
AA Medical Research Center
Flint, Michigan, United States, 48504
Actively Recruiting
23
Trinity Health Michigan Heart
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
24
Cardiology Associates of North MS
Tupelo, Mississippi, United States, 38801
Actively Recruiting
25
AB Clinical Trials
Las Vegas, Nevada, United States, 89119
Actively Recruiting
26
K and R Research LLC
Marion, Ohio, United States, 43302
Actively Recruiting
27
TCV Clinical Studies
Linwood, Pennsylvania, United States, 19061
Active, Not Recruiting
28
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, United States, 19067
Active, Not Recruiting
29
Apex Cardiology Research Associates of Jackson
Jackson, Tennessee, United States, 38301
Actively Recruiting
30
Alliance for Multispecialty Research
Knoxville, Tennessee, United States, 37909
Actively Recruiting
31
Angiocardiac Care of Texas PA
Houston, Texas, United States, 77025
Active, Not Recruiting
32
Dallas Heart and Vascular Consultants PA
Houston, Texas, United States, 77084
Active, Not Recruiting
33
Biopharma Informatic
Katy, Texas, United States, 77479
Active, Not Recruiting
34
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
Active, Not Recruiting
35
Northwest Houston Clinical Research PLLC
Tomball, Texas, United States, 77375
Active, Not Recruiting
36
Progressive Clinical Research
Bountiful, Utah, United States, 84010
Active, Not Recruiting
37
Dominion Medical Associates
Richmond, Virginia, United States, 23219
Active, Not Recruiting
38
MultiCare Ins Research Innovation
Puyallup, Washington, United States, 98372
Actively Recruiting
39
Novartis Investigative Site
Luoyang, Henan, China, 471002
Active, Not Recruiting
40
Novartis Investigative Site
Shenyang, Liaoning, China, 110016
Actively Recruiting
41
Novartis Investigative Site
Wenzhou, Zhejiang, China, 325000
Active, Not Recruiting
42
Novartis Investigative Site
Beijing, China, 100034
Actively Recruiting
43
Novartis Investigative Site
Munich, Bavaria, Germany, 81377
Active, Not Recruiting
44
Novartis Investigative Site
Potsdam, Brandenburg, Germany, 14473
Active, Not Recruiting
45
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany, 60594
Active, Not Recruiting
46
Novartis Investigative Site
Kaiserslautern, Rhineland-Palatinate, Germany, 67655
Active, Not Recruiting
47
Novartis Investigative Site
Dresden, Saxony, Germany, 01307
Active, Not Recruiting
48
Novartis Investigative Site
Bad Krozingen, Germany, 79189
Active, Not Recruiting
49
Novartis Investigative Site
Bad Oeynhausen, Germany, 32545
Active, Not Recruiting
50
Novartis Investigative Site
Berlin, Germany, 10787
Active, Not Recruiting
51
Novartis Investigative Site
Dortmund, Germany, 44137
Active, Not Recruiting
52
Novartis Investigative Site
Essen, Germany, 45147
Withdrawn
53
Novartis Investigative Site
Essen, Germany, 45359
Active, Not Recruiting
54
Novartis Investigative Site
Gladbeck, Germany, 45968
Active, Not Recruiting
55
Novartis Investigative Site
Magdeburg, Germany, 39120
Active, Not Recruiting
56
Novartis Investigative Site
Münster, Germany, 48145
Active, Not Recruiting
57
Novartis Investigative Site
Papenburg, Germany, 26871
Active, Not Recruiting
58
Novartis Investigative Site
Rostock, Germany, 18057
Active, Not Recruiting
59
Novartis Investigative Site
Rüdersdorf, Germany, 15562
Withdrawn
60
Novartis Investigative Site
Warendorf, Germany, 48231
Active, Not Recruiting
61
Novartis Investigative Site
Matsudo, Chiba, Japan, 270-2251
Active, Not Recruiting
62
Novartis Investigative Site
Takamatsu, Kagawa-ken, Japan, 7608557
Active, Not Recruiting
63
Novartis Investigative Site
Miyhazaki, Miyazaki, Japan, 8802102
Active, Not Recruiting
64
Novartis Investigative Site
Suita, Osaka, Japan, 5650853
Actively Recruiting
65
Novartis Investigative Site
Shinjuku Ku, Tokyo, Japan, 160-0008
Actively Recruiting
66
Novartis Investigative Site
Kyoto, Japan, 6078062
Active, Not Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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