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Looking for participantsPhase2

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

NCT ID: NCT06979375

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 31 months (dates as stated)
About the drug or intervention
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.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at whether a medicine called CDR132L can improve the structure and working of the heart, compared with a placebo (a dummy medicine with no active drug), in people with heart failure. Heart failure means the heart does not pump blood as well as it should. The study is funded by Novo Nordisk A/S.

Who can take part

  • Aged 40 to 84 years
  • Diagnosed with heart failure symptoms at least 180 days ago, needing water tablets (diuretics) at least weekly, and in New York Heart Association class II to III (meaning some limits on activity but still able to carry out light tasks)
  • On stable heart failure medicines with no changes for at least 45 days before joining
  • Heart pumping strength (ejection fraction) below 50% on a heart scan
  • A thickened or enlarged main heart chamber (left ventricle), shown on a heart scan
  • Body mass index between 18.5 and 40, and body weight 140 kg or less
  • A blood test (NT-proBNP) showing at least 300 pg/mL, or at least 600 pg/mL if you have atrial fibrillation (an irregular heartbeat)

Who may not be able to

  • Kidney filtering rate (eGFR) below 30, based on a blood test
  • A sudden kidney problem within the past 90 days, in the researcher's opinion
  • A heart attack, unstable chest pain, or a hospital stay for heart failure within the past 30 days
  • Heart failure medicines given by drip within the past 45 days
  • Planned heart procedures, such as bypass surgery, a pacemaker or defibrillator, a procedure to fix an irregular heartbeat, or heart valve repair or replacement
  • A stroke or mini-stroke (transient ischaemic attack) within the past 12 months
  • A condition that might affect the barrier protecting the brain (for example, multiple sclerosis), in the researcher's opinion
  • Severe liver disease, or liver blood tests more than 2.5 times the normal upper limit
  • A known or suspected genetic cause of a thickened heart muscle, such as inherited cardiomyopathy or Fabry disease
  • Suspected or diagnosed cardiac amyloidosis or sarcoidosis (conditions where abnormal material builds up in the heart or other organs)

What taking part involves

  • • CDR132L or a placebo (a dummy medicine with no active drug) — not stated which doses, how it is given, or for how long — ask the trial team

Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
40 Years to 84 Years
Who
All
Number of participants
200
Started
2025-06-30
Last checked
2026-03

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

Biomarkers mentioned

eGFR

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 optimized doses and unchanged drug classes of guideline-directed HF therapy ≥ 45 days prior...
  • ✓Left ventricular ejection fraction (LVEF) less than (\<) 50 percent (%) as assessed by echocardiography at...
  • ✓Left ventricular hypertrophy or left ventricular dilatation assessed by echocardiography at screening measured by...
  • ✓LVMi greater than (\>)88 g/m\^2 for female participants and \>102 g/m\^2 for male participants using the truncated...

Who cannot take part

  • ✗Estimated Glomerular Filtration Rate (eGFR) less than (\<) 30 milliliter/minute/ 1.73-meter square (mL/min/1.73...
  • ✗Participants with an episode of acute kidney failure or acute kidney injury, at the discretion of the...
  • ✗Myocardial infarction, unstable angina pectoris or HF hospitalization within 30 days prior to screening.
  • ✗Participants receiving intravenous HF medications within 45 days prior to randomisation.
  • ✗Stroke or transient ischemic attack within 12 months prior to randomisation.
See the full criteria
Inclusion Criteria: * Age 40-84 years (both inclusive) at the time of signing the informed consent. * Documented symptomatic heart failure (HF) diagnosed greater than or equal to (≥) 180 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 optimized doses and unchanged drug classes of guideline-directed HF therapy ≥ 45 days prior to randomisation. * Left ventricular ejection fraction (LVEF) less than (\<) 50 percent (%) as assessed by echocardiography at screening, measured by central laboratory. * Left ventricular hypertrophy or left ventricular dilatation assessed by echocardiography at screening measured by central laboratory with any of the following: 1. LVMi greater than (\>)88 g/m\^2 for female participants and \>102 g/m\^2 for male participants using the truncated ellipsoid method. 2. LVMi \>95 g/m\^2 for female participants and \>115 g/m\^2 for male participants, using the linear method (cube formula). 3. Left ventricular end-diastolic diameter indexed to body surface area (LVEDDi) \>3.1 cm/m\^2 for female participants and \>3.0 cm/m\^2 for male participants. * Body mass index 18.5-40 kilogram per meter square (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). * N-terminal pro B-type natriuretic peptide (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 (eGFR) less than (\<) 30 milliliter/minute/ 1.73-meter square (mL/min/1.73 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 hospitalization within 30 days prior to screening. * Participants receiving intravenous HF medications within 45 days prior to randomisation. * Planned coronary revascularization, pacemaker/cardioverter-defibrillator/cardiac resynchronization therapy (CRT) implantation, ablation of cardiac arrythmias or 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 greater than (\>) 2.5x 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 B15 2SQ, 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

NOT_YET_RECRUITING

Kings 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

NOT_YET_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: 2026-03