Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06979375 | A Research Study Comparing CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy | PHASE2 | RECRUITING | 200 | — | — | Jun 30, 2025 | Jan 23, 2028 | Mar 11, 2026 | 92 | Australia, Czechia +8 |
| NCT06979362 | A Research Study Comparing Different Doses of CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Preserved Ejection Fraction and Left Ventricular Hypertrophy | PHASE2 | RECRUITING | 200 | — | — | Jun 27, 2025 | Jan 23, 2028 | Mar 11, 2026 | 109 | United States, Canada +7 |
| NCT04045405 | Clinical Study to Assess Safety, PK and PD Parameters of CDR132L | PHASE1 | COMPLETED | 28 | — | — | Jun 21, 2019 | Jun 26, 2020 | Jan 9, 2026 | 1 | United Kingdom |
Ratio to baseline
The incidence and severity of treatment-emergent adverse events (TEAEs)
| Arm | Type | Description |
|---|---|---|
| CDR132L + SoC | EXPERIMENTAL | Participants will receive intravenous infusion of CDR132L once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure. |
| Placebo + SoC | PLACEBO_COMPARATOR | 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. |
| CDR132L: Dose 1 | EXPERIMENTAL | 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. |
| CDR132L: Dose 2 | EXPERIMENTAL | 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. |
| CDR132L: Dose 3 | EXPERIMENTAL | 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. |
| Placebo | PLACEBO_COMPARATOR | 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. |
| CDR132L | EXPERIMENTAL | - |
| Saline | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CDR132L | DRUG | Administered intravenous infusion of CDR132L once every 4 weeks for 48 weeks. |
| Placebo | DRUG | Administered intravenous infusion of placebo once every 4 weeks for 48 weeks. |
Inclusion Criteria: * Age 40-84 years (both inclusive) at the time of signing the informed consent. * Documented symptomatic heart failure (HF) diagnosed greater than or equal to (≥) 180 days prior to screening with at least weekly need for oral diuretic treatment, and New York Heart Association cl...