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A Study of DII235 in Adults With Elevated Lipoprotein(a)
A Study of DII235 in Adults With Elevated Lipoprotein(a)

NCT07235046

Active Not RecruitingPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Lipoprotein Disorder

Interventions: DII235, Saline

Countries: United States, China, Germany, Japan

The main purpose of this study is to determine the safety and efficacy of DII235 in adults with elevated lipoprotein(a).

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 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
Locations (63)
  • Birmingham, Alabama, United States
  • Huntsville, Alabama, United States
  • Little Rock, Arkansas, United States
  • Beverly Hills, California, United States
  • Canoga Park, California, United States
  • Boca Raton, Florida, United States
  • Hollywood, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Ocala, Florida, United States
  • Pensacola, Florida, United States
  • Wellington, Florida, United States
  • Tucker, Georgia, United States
  • Niles, Illinois, United States
  • Lafayette, Louisiana, United States
  • West Monroe, Louisiana, United States
  • Beltsville, Maryland, United States
  • Ft. Washington, Maryland, United States
  • Lanham, Maryland, United States
  • Flint, Michigan, United States
  • Ypsilanti, Michigan, United States
  • Tupelo, Mississippi, United States
  • Las Vegas, Nevada, United States
  • Marion, Ohio, United States
  • Linwood, Pennsylvania, United States
  • Yardley, Pennsylvania, United States
  • Jackson, Tennessee, United States
  • Knoxville, Tennessee, United States
  • Houston, Texas, United States
  • + 33 more on CT.gov