RecruitingPhase 2NCT07235046
A Study of DII235 in Adults With Elevated Lipoprotein(a)
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate Efficacy, Safety, and Tolerability of DII235 in Adults With Elevated Lipoprotein(a)
Sponsor
Novartis Pharmaceuticals
Enrollment
200 participants
Start Date
Dec 2, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The main purpose of this study is to determine the safety and efficacy of DII235 in adults with elevated lipoprotein(a).
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria4
- 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 Criteria5
- 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
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Interventions
DRUGDII235
Solution for injection
DRUGSaline
solution for injection
Locations(66)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07235046