Recruiting
Phase 2

CDR132L

Sponsor:

Novo Nordisk A/S

Code:

NCT06979362

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

CDR132L

Placebo

Study Details

Brief summary:

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.

Conditions

Heart Failure

Study ID

NCT06979362

Start date

Jun 27, 2025

Status verified date

Aug, 2026

Completion date

Jul 25, 2028

Anticipated

Primary completion date

Nov 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 40-84 years (both inclusive) at the time of signing the informed consent
  • Documented symptomatic chronic heart failure (HF) diagnosed greater than or equal to (≥) 90 days prior to screening with at least weekly need for oral diuretic treatment, and New York Heart Association class II-III at screening
  • Clinically stable and on optimised doses and unchanged drug classes of guideline-directed HF therapy ≥45 days prior to randomisation
  • Left ventricular ejection fraction ≥50% as assessed by echocardiography at screening, measured by central laboratory
  • Left ventricular hypertrophy assessed by echocardiography at screening measured by central laboratory with any of the following:

1. LVMi (greater than) >88 gram per square meter (g/m\^2) for female participants and >102 g/m\^2 for male participants, using the truncated ellipsoid method measured by central laboratory
2. LVMi >95 g/m2 for female participants and >115 g/m2 for male participants using the linear method (cube formula).
3. Interventricular septum diameter measured in diastole (IVSd) in the parasternal long axis view ≥1.1 cm for female participants and ≥1.2 cm for male participants.
  • Body mass index 18.5-40 kilogram per square meter (kg/m\^2) (both inclusive) and body weight less than or equal to (≤) 140 kilogram (kg). Body mass index is calculated in the electronic case report form based on height and body weight at the screening visit (visit 1)
  • NT-proBNP ≥300 picograms per milliliter (pg/mL); NT-proBNP ≥600 pg/mL if atrial fibrillation/flutter is present at time of screening, measured by central laboratory

Exclusion Criteria:

  • Estimated glomerular filtration rate lesser than (<) 30 milliliter per minute (mL/min)/1.73 square meter (m\^2) at time of screening, measured by central laboratory
  • Participants with an episode of acute kidney failure or acute kidney injury, at the discretion of the investigator, within 90 days prior to randomisation
  • Myocardial infarction, unstable angina pectoris or HF hospitalisation within 30 days prior to screening
  • Participants receiving intravenous HF medications within 45 days prior to randomisation
  • Participants with CRT, pacemaker or implantable cardioverter-defibrillator
  • Planned coronary revascularisation, pacemaker/cardioverter-defibrillator/CRT implantation, ablation of cardiac arrythmias and valve repair/replacement at the time of randomisation
  • Stroke or transient ischemic attack within 12 months prior to randomisation
  • Participants with potential disruption of the blood-brain barrier (e.g., multiple sclerosis), in the opinion of the investigator
  • Known history of severe liver disease and/or alanine aminotransferase or aspartate aminotransferase >2.5 x upper limit of normal at screening, measured by central laboratory
  • Known genetic (or highly suspected due to family history) cause of increased cardiac mass (including dilated cardiomyopathy, Fabry disease and likely pathogenic or pathogenic variants within hypertrophic cardiomyopathy \[HCM\]).
  • Participants with suspected or diagnosed cardiac amyloidosis or sarcoidosis.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

CDR132L

CDR132L will be administered intravenously once every 4 weeks.

Placebo

Placebo will be administered intravenously once every 4 weeks.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178clinicaltrials@novonordisk.com

Locations

Univ of Alabama Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Valley Clinical Trials

Recruiting

Covina, California, United States, 91723

UCSD NAFLD Research Center

Recruiting

La Jolla, California, United States, 92037

Valley Clinical Trials

Recruiting

Northridge, California, United States, 91325

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94110

University of California San Francisco UCSF

Recruiting

San Francisco, California, United States, 94143

Harbor-UCLA Medical Center

Recruiting

Torrance, California, United States, 90502

Inpatient Research Clinic LLC

Recruiting

Miami Lakes, Florida, United States, 33014

Henry Ford Hospital_Detroit

Recruiting

Detroit, Michigan, United States, 48202

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Capital Area Research LLC

Recruiting

Camp Hill, Pennsylvania, United States, 17011

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390-8830

East Texas Cardiology PA

Recruiting

Houston, Texas, United States, 77002

Inova Heart and Vascular Institute

Recruiting

Falls Church, Virginia, United States, 22042

Cardio Health Clinical Trials

Recruiting

Mississauga, Ontario, Canada, L5M 2S6

University of Ottawa Heart Institute (UOHI)

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Winchester Dist Memorial Hosp

Recruiting

Winchester, Ontario, Canada, K0C 2K0

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-08-05.