Status:
RECRUITING
A Study of DII235 in Adults With Elevated Lipoprotein(a)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Lipoprotein Disorder
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to determine the safety and efficacy of DII235 in adults with elevated lipoprotein(a).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 8 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07235046
Start Date
December 5 2025
End Date
September 8 2028
Last Update
March 3 2026
Active Locations (60)
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1
Parkway Medical Center
Birmingham, Alabama, United States, 35215
2
Heart Center Research Llc
Huntsville, Alabama, United States, 35801
3
Cardiology and Medicine Clinic PA
Little Rock, Arkansas, United States, 72204
4
National Heart Institute
Beverly Hills, California, United States, 90211