Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CDR132L (i.v.)
CDR132L · 5 trials · 4 indications
Ratio to baseline
Percent change from baseline (screening to occur at least 3 days after MI diagnosis as measured by ECHO \[central laboratory\]) in Left Ventricular End-Systolic Volume (LVESVI) at Month 6.
The incidence and severity of treatment-emergent adverse events (TEAEs)
Measured as hours\*nanograms per milliliter (h\*ng/mL)
| 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 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 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 SoC therapy for heart failure. |
| CDR132L 5 mg | EXPERIMENTAL | CDR132L 5 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57 |
| CDR132L 10 mg | EXPERIMENTAL | CDR132L 10 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57 |
| CDR132L | EXPERIMENTAL | - |
| Saline | PLACEBO_COMPARATOR | - |
| Sequence A | EXPERIMENTAL | Participants will be given dose 1 of CDR132L intravenously, followed by dose 1 of CDR132L administered subcutaneously. |
| Sequence B | EXPERIMENTAL | Participants will be given dose 1 of CDR132L subcutaneously, followed by dose 1 of CDR132L administered intravenously. |
| Sequence C | EXPERIMENTAL | Participants will be given dose 2 of CDR132L intravenously, followed by dose 2 of CDR132L administered subcutaneously. |
| Sequence D | EXPERIMENTAL | Participants will be given dose 2 of CDR132L subcutaneously, followed by dose 2 of CDR132L administered intravenously. |
| 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. |
| Placebo to CDR132L | DRUG | Placebo to CDR132L |
| CDR132L (i.v.) | DRUG | CDR132L will be administered intravenously. |
| CDR132L (s.c.) | DRUG | CDR132L will be administered subcutaneously. |
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...
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CDR132L is an investigational small molecule developed by Novo Nordisk A/S for cardiovascular conditions, specifically heart failure and acute myocardial infarction. It is in Phase 2 clinical development and is being studied in randomized, double-blind, placebo-controlled trials. It is also referred to as CDR132L (i.v.) in some study materials.
CDR132L is being studied for heart failure, including heart failure with reduced or mildly reduced ejection fraction and heart failure with preserved ejection fraction, each with left ventricular hypertrophy. It is also being evaluated in patients with reduced left ventricular ejection fraction after acute myocardial infarction. It is investigational and has not been approved for any use.
CDR132L is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical program evaluating the drug across heart failure and post-myocardial infarction populations.
CDR132L is in Phase 2 clinical development. Three Phase 2 trials and one Phase 1 trial make up the program, with three studies currently recruiting and one Phase 2 study completed. CDR132L is investigational and has not been approved by the FDA.
CDR132L is being studied in NCT06979375, a Phase 2 trial in heart failure with reduced or mildly reduced ejection fraction and left ventricular hypertrophy, and NCT06979362, a Phase 2 dose-comparison trial in heart failure with preserved ejection fraction and left ventricular hypertrophy. A Phase 1 pharmacokinetic study, NCT07656454, is also recruiting. The completed Phase 2 trial is NCT05350969.
Yes. CDR132L (i.v.) refers to the same investigational drug, CDR132L, developed by Novo Nordisk A/S. The parenthetical notation reflects intravenous administration. Both names refer to the small molecule being studied in Phase 2 trials for heart failure and acute myocardial infarction.