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Taking people in GermanyPhase 2

Tests CDR132L against placebo for heart failure with a thickened heart wall

Tests CDR132L against placebo in adults with heart failure and a thickened heart.

Key facts

Who runs it
Novo Nordisk A/S
Where
Berlin, Dresden, Essen, Frankfurt Am Main, Halle Saale, Hanover, Heidelberg, and Kiel, GermanySee the 8 sitesAlso in 8 other countries, 101 sites
Trial code
Registry title
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
Status
Recruiting
Phase
Phase 2
People taking part
200 people, planned
Started
27 Jun 2025
Expected to end
25 Jul 2028
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • CDR132L
  • Placebo
Record updated
5 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 40-84 with long-term symptomatic heart failure, a pumping function of 40% or more, and a thickened heart muscle.

Age
40 to 84 years
Sex
All sexes can join.
Disease stage
Symptomatic chronic heart failure diagnosed at least 90 days before screening, NYHA class II-III, left ventricular ejection fraction of 40% or more, and left ventricular hypertrophy (thickened heart muscle) seen on echocardiography.
Earlier treatment
Must be clinically stable on optimised doses and unchanged drug classes of guideline-directed heart failure therapy for at least 45 days before randomisation. Needs oral diuretic treatment at least weekly and/or an SGLT2i.
Biomarker or test result
NT-proBNP of 300 pg/mL or more (600 pg/mL or more if atrial fibrillation/flutter is present at screening). Body mass index 18.5-45 kg/m² and body weight 140 kg (309 lb) or less.

Main reasons for not taking part

  • Kidney function eGFR below 30 mL/min/1.73 m² at screening
  • Heart attack, unstable angina or heart failure hospitalisation within 30 days before screening
  • Pacemaker, implantable cardioverter-defibrillator or CRT device
  • Stroke or transient ischemic attack within 12 months before randomisation
  • Known genetic cause of increased heart muscle mass, or suspected or diagnosed cardiac amyloidosis or sarcoidosis

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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:; 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; LVMi >95 g/m2 for female participants and >115 g/m2 for male participants using the linear method (cube formula); 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

Who cannot take part

  • 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
  • Stroke or transient ischemic attack within 12 months prior to randomisation
  • Planned coronary revascularisation, pacemaker/cardioverter-defibrillator/CRT implantation, ablation of cardiac arrythmias and valve repair/replacement at the time of randomisation
  • 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
  • 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
  • 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
  • Participants with CRT, pacemaker or implantable cardioverter-defibrillator
  • Participants with potential disruption of the blood-brain barrier (e.g., multiple sclerosis), in the opinion of the investigator

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 84 years old?

Where in Germany

Also in 8 other countries, 101 sites

  • Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
  • Herzzentrum Dresden GmbH UniversitaetsklinikDresden, GermanyTaking people
  • Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
  • Universitaetsklinikum Frankfurt AöRFrankfurt Am Main, GermanyTaking people
  • Universitaetsklinikum Halle (Saale) AöRHalle Saale, GermanyTaking people
  • Medizinische Hochschule HannoverHanover, GermanyTaking people
  • Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyTaking people
  • Universitaetsklinikum Schleswig-Holstein AöRKiel, GermanyTaking people

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • CDR132L: Dose 1Treatment being tested

    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.

    Treatment: CDR132L

  • CDR132L: Dose 2Treatment being tested

    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 SoC therapy for heart failure.

    Treatment: CDR132L

  • CDR132L: Dose 3Treatment being tested

    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 SoC therapy for heart failure.

    Treatment: CDR132L

  • PlaceboPlacebo, for comparison

    Participants will receive intravenous infusion of placebo once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed SoC therapy for heart failure.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Phase 2, Multicentre, Randomised, Double-blind, Placebo-controlled Safety and Efficacy Study of CDR132L on Reverse Cardiac Remodelling in Participants With Heart Failure With Preserved Ejection Fraction and Left Ventricular Hypertrophy
Plain-language title
Tests CDR132L against placebo for heart failure with a thickened heart wallGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06979362, who can take part
Record updated
5 October 2026