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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novo Nordisk A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

25 Jun 2025 → ongoing

Decision date (initial)

2025-05-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2024-515797-27-00

WHO UTN

U1111-1313-4591

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Pharmacodynamic, Efficacy, Therapy

To confirm superiority of 00 mg/kg CDR132L Q4W versus placebo Q4W, both added to standard of care, on change in normalised miR-132 from baseline to week 24 in
participants with HFrEF/HFmrEF and LVH.

Secondary objectives 3

1. To compare the effect of 00 mg/kg CDR132L Q4W versus placebo Q4W on the composite Z score based on the 3 outcome measures LVEDVi, LVESVi and NT-proBNP.
2. To compare the effect of 00 mg/kg CDR132L Q4W versus placebo Q4W on safety and tolerability.
3. To compare the effect of 00 mg/kg CDR132L Q4W versus placebo Q4W on safety and tolerability.

Conditions and MedDRA coding

Heart Failure with Reduced/Mildly Reducede Ejection Fraction and Left Ventricular Hypertrophy.

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1. Age 40-84 years (both inclusive) at the time of signing the informed consent.
2. 2. Documented symptomatic HF diagnosed ≥180 days prior to screening with at least weekly need for oral diuretic treatment, and New York Heart Association class II−III at screening.
3. 3. Clinically stable and on optimised doses and unchanged drug classes of guideline-directed HF therapy ≥45 days prior to randomisation.
4. 4. LVEF <50% as assessed by echocardiography at screening, measured by central laboratory.
5. 5. Left ventricular hypertrophy or left ventricular dilatation assessed by echocardiography at screening measured by central laboratory with any of the following: a. LVMi >88 g/m2 for female participants and >102 g/m2 for male participants, using the truncated ellipsoid method. b. LVMi >95 g/m2 for female participants and >115 g/m2 for male participants, using the linear method (cube formula). c. Left ventricular end-diastolic diameter indexed to body surface area (LVEDDi) >3.1 cm/m2 for female participants and >3.0 cm/m2 for male participants.
6. 7. Body mass index 18.5-40 kg/m2 (both inclusive) and body weight ≤140 kg. Body mass index is calculated in the electronic case report form based on height and body weight at the screening visit (visit 1).
7. 8. NT-proBNP ≥300 pg/mL; NT-proBNP ≥600 pg/mL if atrial fibrillation/flutter is present at time of screening, measured by central laboratory.

Exclusion criteria 10

1. 1. eGFR <30 mL/min/1.73 m2 at time of screening, measured by central laboratory.
2. 2. Participants with an episode of acute kidney failure or acute kidney injury, at the discretion of the investigator, within 90 days prior to randomisation.
3. 3. Myocardial infarction, unstable angina pectoris or HF hospitalisation within 30 days prior to screening.
4. 4. Participants receiving intravenous HF medications within 45 days prior to randomisation.
5. 5. Planned coronary revascularisation, pacemaker/cardioverter-defibrillator/CRT implantation, ablation of cardiac arrythmias or valve repair/replacement at the time of randomisation.
6. 6. Stroke or transient ischemic attack within 12 months prior to randomisation.
7. 7. Participants with potential disruption of the blood-brain barrier (e.g., multiple sclerosis), in the opinion of the investigator.
8. 8. Known history of severe liver disease and/or alanine aminotransferase or aspartate aminotransferase >2.5x upper limit of normal at screening, measured by central laboratory.
9. 9. 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])).
10. 10. Participants with suspected or diagnosed cardiac amyloidosis or sarcoidosis.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in normalised miR-132 from baseline (V2) to week 24 (V14). Unit:  Ratio to baseline

Secondary endpoints 3

1. Change in composite Z score based on the 3 outcome measures LVEDVi, LVESVi and NT-proBNP from baseline (V2) to week 24 (V14). Unit: Score
2. Number of adverse events from baseline (V2) to week 24 (V14). Unit: Count
3. Number of adverse events from baseline (V2) to week 60 (V27). Unit: Count

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novo Nordisk A/S

Sponsor organisation

Novo Nordisk A/S

Address

Novo Alle 1

City

Bagsvaerd

Postcode

2880

Country

Denmark

Scientific contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Public contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Third parties 11

Locations

5 EU/EEA countries · 43 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 73 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications