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

Conditions

• Heart Failure

Eligibility Criteria

Sex

ALL

Age

40 Years - 84 Years

Healthy Volunteers

Not accepted

Interventions

• CDR132L — DRUG
  CDR132L will be administered intravenously once every 4 weeks.
• Placebo — DRUG
  Placebo will be administered intravenously once every 4 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 27, 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: Dose 1
  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.
• Experimental: CDR132L: Dose 2
  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.
• Experimental: CDR132L: Dose 3
  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 Comparator: Placebo
  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

• Novo Nordisk
  (+1) 866-867-7178
  [email protected]

Locations (29)

Find similar trials in Birmingham, AL

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