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)
Novartis Pharmaceuticals
Summary
The main purpose of this study is to determine the safety and efficacy of DII235 in adults with elevated lipoprotein(a).
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * 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 surgic…
Interventions
- DrugDII235
Solution for injection
- DrugSaline
solution for injection
Locations (66)
- Parkway Medical CenterBirmingham, Alabama
- Heart Center Research LlcHuntsville, Alabama
- Cardiology and Medicine Clinic PALittle Rock, Arkansas
- National Heart InstituteBeverly Hills, California
- Alliance ClinicalCanoga Park, California
- Excel Medical Clinical Trials LLCBoca Raton, Florida