BridgeMD
New treatment option for Aortic Stenosis
Official title A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
ClinicalTrials.gov ID: NCT05646381
What this study is testing
What is Pelacarsen (TQJ230) 80mg?
Pelacarsen (TQJ230) 80mg is an investigational medicine, given as a monthly injection under the skin, being studied as a potential treatment for aortic stenosis.
Also referred to as TQJ230.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join if
- Male and female ≥50 to \<80 years of age at Screening Part II
- Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory
- Mild or moderate calcific aortic valve stenosis
- At the randomization visit, participant must be optimally treated for existing CV risk factors
You likely can't join if
- Severe calcific aortic valve stenosis
- Uncontrolled hypertension
- History of malignancy of any organ system
- History of hemorrhagic stroke or other major bleeding
- Platelet count ≤ LLN
- Active liver disease or hepatic dysfunction
See the full eligibility criteria
- Male and female ≥50 to \<80 years of age at Screening Part II
- Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory
- Mild or moderate calcific aortic valve stenosis
- At the randomization visit, participant must be optimally treated for existing CV risk factors
- Severe calcific aortic valve stenosis
- Uncontrolled hypertension
- History of malignancy of any organ system
- History of hemorrhagic stroke or other major bleeding
- Platelet count ≤ LLN
- Active liver disease or hepatic dysfunction
- Significant kidney disease
- Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Beverly Hills, California, United States
- Covina, California, United States
- Northridge, California, United States
- Palo Alto, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Boca Raton, Florida, United States
- Bradenton, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Naples, Florida, United States
- Overland Park, Kansas, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Flint, Michigan, United States
- Royal Oak, Michigan, United States
- Minneapolis, Minnesota, United States
- Summit, New Jersey, United States
- Albany, New York, United States
+ 92 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Beverly Hills, California, United States; Covina, California, United States; Northridge, California, United States; Palo Alto, California, United States; San Diego, California, United States and 106 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.