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

Sponsor
Novo Nordisk A/S
Study ID
NCT06979375
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2025
Status verified
Mar 2026
Primary completion
May 16, 2027
Completion
Jan 23, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CDR132L + SoC
    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 Comparator: Placebo + SoC
    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.

Primary Outcome Measure

Main Phase: Change in normalised microRNA-132-3p (miR-132) [ Time Frame: From baseline to week 24 ]

Central Contacts

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