A Phase 2 interventional study of CDR132L and Placebo in Heart Failure, sponsored by Novo Nordisk A/S. Recruiting at 118 sites in 9 countries. Open to participants aged 40 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment
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.
Left ventricular hypertrophy assessed by echocardiography at screening measured by central laboratory with any of the following:
Exclusion Criteria:
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.
Drug: CDR132L
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 SoC therapy for heart failure.
Drug: CDR132L
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 SoC therapy for heart failure.
Drug: CDR132L
Participants will receive intravenous infusion of placebo once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed SoC therapy for heart failure.
Drug: Placebo
CDR132L will be administered intravenously once every 4 weeks.
Placebo will be administered intravenously once every 4 weeks.
Main phase: Change in normalised microRNA-132-3p (miR-132)
Measured as ratio to baseline.
Time frame: From baseline to week 24
Main phase: Change in composite Z-score based on the 3 outcome measures LVMi (CMR), LAVi (CMR) and NT-proBNP
The composite Z-score is calculated as the mean of the participant's 3 Z-scores for the change in the 3 outcome measures: left ventricular mass indexed to body surface area \[LVMi (Cardiovascular Magnetic Resonance \[CMR\])\], left atrial volume indexed to body surface area \[LAVi (CMR)\] and N-terminal pro B-type natriuretic peptide (NT-proBNP).
Time frame: From baseline to week 24
Main phase: Change in normalised miR-132
Measured as ratio to baseline.
Time frame: From baseline to week 24
Main phase: Number of adverse events
Measured as count of events.
Time frame: From baseline to week 24
Extension phase: Number of adverse events
Measured as count of events.
Time frame: From baseline to week 60
Showing the first 100 of 118 sites across 9 countries.
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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Novo Nordisk A/S