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Looking for participantsPhase2

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

Sponsor: Novo Nordisk A/S

NCT ID: NCT06979362

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
CDR132L (drug), Placebo (drug)
How long the study runs
Study runs about 37 months (dates as stated)
About the drug or intervention
CDR132L — drug: CDR132L will be administered intravenously once every 4 weeks. · Placebo — drug: Placebo will be administered intravenously once every 4 weeks.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
40 Years to 84 Years
Who
All
Number of participants
200
Started
2025-06-27
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure
  • • Phase2 - 200 participants
  • • 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

Who can take part?

  • • Ages 40 Years to 84 Years
  • • Diagnosed with heart failure

Where?

  • • Birmingham - Trialmed - Midlands
  • • High Wycombe - Wycombe General Hospital
  • • London - St Bartholomew's Hospital - Cardiac Research Office
  • • London - St Bartholomew's Hospital - Cardiology
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Heart Failure

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years - 84 Years
  • Who can join: All genders

What the study is looking for

  • ✓Age 40-84 years (both inclusive) at the time of signing the agreement to take part
  • ✓Clinically stable and on optimised doses and unchanged drug classes of guideline-directed HF therapy ≥45 days prior...
  • ✓Left ventricular ejection fraction ≥40% 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...
  • ✓LVMi (greater than) \>88 gram per square meter (g/m\^2) for female participants and \>102 g/m\^2 for male...

Who cannot take part

  • ✗Estimated glomerular filtration rate lesser than (\<) 30 milliliter per minute (mL/min)/1.73 square meter (m\^2) at...
  • ✗Participants with an episode of acute kidney failure or acute kidney injury, at the discretion of the investigator,...
  • ✗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
See the full criteria
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/or a sodium-glucose cotransporter-2 inhibitor (SGLT2i), 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 ≥40% 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 18.5-45 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.

Where Is This Study? (8 UK sites)

Trialmed - Midlands

Birmingham B16 8QQ, United Kingdom

Recruiting

Wycombe General Hospital

High Wycombe HP11 2TT, United Kingdom

Recruiting

St Bartholomew's Hospital - Cardiac Research Office

London EC1A 7BE, United Kingdom

NOT_YET_RECRUITING

St Bartholomew's Hospital - Cardiology

London EC1A 7BE, United Kingdom

Recruiting

King's College Hospital

London SE5 9RS, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

The Royal Brompton Hospital - Respiratory CRF

London SW3 6HP, United Kingdom

Recruiting

The James Cook University Hospital - Cardiology

Middlesbrough TS4 3BW, United Kingdom

Recruiting

Southampton General Hospital

Southampton SO16 6YD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

How to Get in Touch

Novo Nordisk

Sponsor contact

CONTACT

(+1) 866-867-7178 clinicaltrials@novonordisk.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09