Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With CVD (Lp(a)HORIZON)

• ClinicalTrials.gov Identifier: NCT04023552
• Recruitment Status: Recruiting
• First Posted: July 17, 2019
• Last Update Posted: January 15, 2021
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: July 16, 2019
• First Posted Date: July 17, 2019
• Last Update Posted Date: January 15, 2021
• Actual Study Start Date: December 12, 2019
• Estimated Primary Completion Date: June 7, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 16, 2019)

• Time to first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in patients with elevated Lp(a) ≥ 70 mg/dL [ Time Frame: approximately 4 years ]
  Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in the overall study population with established CVD and (Lp(a) ≥ 70 mg/dL)
• Time to the first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in a population of patients with elevated Lp(a) ≥ 90 mg/dL. [ Time Frame: approximately 4 years ]
  Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in the overall study population with established CVD and (Lp(a) ≥ 90 mg/dL)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 16, 2019)

• Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of major adverse cardiovascular events (CV death, non-fatal MI, and non-fatal stroke) [ Time Frame: approximately 4 years ]
  Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of the MACE composite of CV death, nonfatal MI and non-fatal stroke.
• Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of coronary heart disease: coronary heart disease death, non-fatal MI, urgent coronary re-vascularization requiring hospitalization [ Time Frame: approximately 4 years ]
  Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of the composite of coronary heart disease (CHD) outcomes: death due to CHD, nonfatal MI and urgent coronary revascularization requiring hospitalization.
• Number of participants with confirmed all-cause death [ Time Frame: approximately 4 years ]
  Evaluation by clinical endpoint committee the rate of all-cause death

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With CVD
• Official Title: A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With Established Cardiovascular Disease
• Brief Summary: This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Cardiovascular Disease and Lipoprotein(a)

Intervention

• Drug: TQJ230
  TQJ230 80 mg injected monthly administered subcutaneously
• Drug: Placebo
  Placebo to match TQJ230 prefilled syringe to be injected subcutaneously
  Other Name: Placebo to match TQJ230

Study Arms

• Experimental: TQJ230
  TQJ230 80 mg injected monthly administered subcutaneously
  Intervention: Drug: TQJ230
• Placebo Comparator: Placebo
  Monthly subcutaneous injections.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 16, 2019): 7680
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 10, 2024
• Estimated Primary Completion Date: June 7, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria

• Lp(a) ≥ 70 mg/dL at the screening visit, measured at the Central laboratory
• Myocardial infarction: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
• Ischemic stroke: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
• Clinically significant symptomatic peripheral artery disease

Key Exclusion Criteria

• Uncontrolled hypertension
• Heart failure New York Heart Association (NYHA) class IV
• 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 at the end.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Novartis Pharmaceuticals; 1-888-669-6682; novartis.email@novartis.com

Contact: Novartis Pharmaceuticals; +41613241111

• Listed Location Countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, China, Colombia, Czechia, Denmark, Germany, Hong Kong, Hungary, Iceland, India, Israel, Italy, Japan, Korea, Republic of, Netherlands, Norway, Poland, Portugal, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Administrative Information

• NCT Number: NCT04023552
• Other Study ID Numbers: CTQJ230A12301; CTQJ230A12301 ( Other Identifier: Novartis ); 2019-001076-11 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient -level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with the applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

• Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Study Sponsor: Novartis Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: January 2021