CDR132L for Heart Failure

(8212-Preserved Trial)

Recruiting at 83 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novo Nordisk A/S

Must be taking: Diuretics

Must not be taking: Intravenous HF medications

Disqualifiers: Kidney failure, Myocardial infarction, Stroke, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 48 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will look into how CDR132L (a potential new medicine) works on the structure and function of the heart in people living with heart failure. Participants will either get CDR132L or placebo (a medicine which has no effect on the body), which treatment the participants get is decided by chance. The study will last for about 60 weeks.

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

This trial is for individuals with heart failure who have preserved ejection fraction and left ventricular hypertrophy. Specific eligibility criteria are not provided, but typically participants must meet certain health standards to be included.

Inclusion Criteria

Left ventricular ejection fraction ≥50% as assessed by echocardiography at screening, measured by central laboratory

NT-proBNP ≥300 pg/mL; NT-proBNP ≥600 pg/mL if atrial fibrillation/flutter is present at time of screening, measured by central laboratory

I am between 40 and 84 years old.

Exclusion Criteria

My kidney function is severely reduced.

Participants with CRT, pacemaker or implantable cardioverter-defibrillator

Participants with potential disruption of the blood-brain barrier, in the opinion of the investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous infusion of CDR132L or placebo once every 4 weeks for 48 weeks

48 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Extension

Participants continue to be monitored for adverse events up to week 60

12 weeks

Treatment Details

Interventions

• CDR132L

Trial Overview The study compares different doses of a potential new medicine called CDR132L against a placebo over approximately 60 weeks. The aim is to see how CDR132L affects the structure and function of the heart in patients with heart failure.

Participant Groups

Group I: CDR132L: Dose 3 Experimental Treatment 1 Intervention

Participants will receive intravenous infusion of CDR132L dose 3 once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure.

Group II: CDR132L: Dose 2 Experimental Treatment 1 Intervention

Participants will receive intravenous infusion of CDR132L dose 2 once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure.

Group III: CDR132L: Dose 1 Experimental Treatment 1 Intervention

Participants will receive intravenous infusion of CDR132L dose 1 once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure.

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive intravenous infusion of placebo once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen