Phase 1 Cardiomyopathy Trial, Recruiting NCT07448623 Sponsor: Novo Nordisk A/S Condition: Cardiomyopathy
Back to Cardiomyopathy

Phase 1 Cardiomyopathy Trial, Recruiting

NCT07448623
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have given written consent to participate before any study activities begin.
  • People of any gender.
  • People aged 60 years or older at the time of signing the consent form.
  • People who have a confirmed diagnosis of Transthyretin Amyloid Cardiomyopathy (ATTR-CM), a condition where a specific protein builds up in the heart, either due to an inherited gene change or occurring without a known genetic cause.
  • People whose diagnosis is supported by evidence of amyloid protein in the heart, shown through one of the following: a heart tissue biopsy confirming the protein buildup; OR a specific nuclear heart scan showing significant protein deposits, combined with a tissue biopsy from another part of the body confirming the same protein; OR a specific nuclear heart scan showing significant protein deposits, combined with normal blood and urine test results that rule out a different type of protein buildup.
  • People whose heart ultrasound (echocardiogram) shows thickened heart walls — at least 13mm for women or at least 14mm for men (a scan taken within the past 2 years may be accepted).
  • People who have experienced ongoing heart failure, shown by either at least one hospital admission for heart failure between 3 months and 2 years ago, OR a history of heart failure symptoms such as fluid buildup, shortness of breath, or leg swelling that requires ongoing treatment with a specific type of fluid-reducing medication called a loop diuretic.

Who may not be able to join:

  • People with a known or suspected allergic reaction to the study treatment or related substances.
  • People who have previously signed a consent form for this same study.
  • People who are female and are currently pregnant, breastfeeding, planning to become pregnant, or who are capable of becoming pregnant.
  • People who are currently enrolled in another interventional clinical trial (meaning they have already signed a consent form for another study involving a treatment or procedure).
  • People who have taken part in research studies involving radiation exposure within the year before screening for this trial.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Transparency dept. 2834, Novo Nordisk A/S

Phone: (+1) 866-867-7178

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
2 March 2026
Est. completion
30 May 2027

Where this trial is recruiting

🇳🇱 Netherlands

Primary endpoints

Mean Standard Uptake Value Ratio (SUVRmean) in myocardium; Net uptake rate constant (Ki) in myocardium; Change in SUVRmean in myocardium

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov