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 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 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 being developed for cardiovascular conditions, specifically heart failure and acute myocardial infarction. It is also being studied in healthy volunteers to assess its safety and pharmacokinetics. The drug is currently in clinical development and has not been approved by regulatory authorities.
CDR132L is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with heart failure and other cardiovascular conditions.
CDR132L is in Phase 1 and Phase 2 clinical trials. Phase 1 studies are assessing safety, pharmacokinetics, and pharmacodynamics in healthy volunteers and heart failure patients. Phase 2 trials are recruiting participants to evaluate the drug's effects on heart structure and function in people with heart failure and left ventricular hypertrophy.
CDR132L is being studied in several clinical trials. NCT04045405 is a completed Phase 1 study in heart failure patients in the UK. NCT06979362 and NCT06979375 are recruiting Phase 2 trials in heart failure patients with preserved or reduced ejection fraction and left ventricular hypertrophy. NCT07656454 is a recruiting Phase 1 study comparing subcutaneous and intravenous administration in healthy participants.
Yes, CDR132L is also known as CDR132L (i.v.), referring to the intravenous route of administration. This alternative name is used in some clinical contexts to specify how the drug is given. The drug is being studied in both intravenous and subcutaneous forms.