search
Back to results

A Research Study to Look at How a New Medicine Called NNC6019-0001 Works and How Safe it is for People Who Have Heart Disease Due to Transthyretin (TTR) Amyloidosis

Primary Purpose

Transthyretin Amyloid Cardiomyopathy (ATTR CM)

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NNC6019-0001
Placebo (NNC6019-0001)
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transthyretin Amyloid Cardiomyopathy (ATTR CM)

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female.
  • Age greater than or equal to (>=) 18 to less than (<) 85 years at the time of signing informed consent.
  • Have an established diagnosis of Transthyretin amyloid cardiomyopathy (ATTR CM) with either wild-type transhyretin (TTR) or hereditary transthyretin (TTR) genotype as per local standards.
  • Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the randomisation visit.
  • Known end-diastolic interventricular septal wall thickness greater than or equal to (>=) 12 millimeters (mm).
  • Presently classified as New York Heart Association (NYHA) Class II-III.
  • N-terminal-pro brain natriuretic peptide (NT-proBNP) concentration greater than or equal to (>=) 650 picograms per milliliter (pg/mL) in sinus cardiac rhythm and greater than (>) 1000 pg/mL in atrial fibrillation at screening.
  • Completed greater than or equal to (>=) 150 meters to less than or equal to (<=) 450 meters on the 6-minute walk test (MWT) at screening.
  • Estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 25 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2) at screening.

Exclusion Criteria:

  • Cardiomyopathy not primarily caused by transthyretin amyloid cardiomyopathy transthyretin amyloid cardiomyopathy (ATTR CM), for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease.
  • A prior solid organ transplant.
  • Planned solid organ transplant during the study.
  • Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, insitu carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before screening.
  • Current treatment with calcium channel blockers with conduction system effects (example [e.g.], verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response.
  • Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularization, cardiac valve repair, or major surgery within 3 months of screening.
  • Body weight >120 kilogram (kg) (264.6 pounds [lb]) at screening.
  • History of contrast allergy or adverse reactions to gadolinium-containing agents.

Sites / Locations

  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

NNC6019-0001, 10 mg/kg

NNC6019-0001, 60 mg/kg

Placebo

Arm Description

Participants will receive intravenous (i.v.) infusion of 10 milligrams per kilograms (mg/kg) NNC6019-0001 every 4 weeks (Q4W) added to standard of care until week 52.

Participants will receive i.v. infusion of 60 mg/kg NNC6019-0001 Q4W added to standard of care until week 52.

Participants will receive i.v. infusion of placebo (NNC6019-0001) Q4W added to standard of care until week 52.

Outcomes

Primary Outcome Measures

Change in 6-minute walk test (6-MWT)
Measured in Meters
Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)
Measured in Percentage

Secondary Outcome Measures

Change in myocardial extracellular volume (ECV)
Measured in Percentage (%)-points
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)
The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Change in neuropathy impairment score (NIS)
NIS is a clinical assessment that tests muscle strength, reflex activity, and sensation of toes and fingers, and can be used to assess neurologic function in hereditary transthyretin amyloid (hATTR). The total NIS score is graded on a scale of 0-244, with a higher score indicating greater impairment.
Change in troponin I
Measured in nanogram per milliliter (ng/mL)
Change in global longitudinal strain (GLS) on echocardiography
Measured in Percentage (%)-points
Number of treatment emergent adverse events
Measured as Events
Time to occurrence of all-cause mortality
Measured in Weeks
Number of cardiovascular (CV) events comprising hospitalisation due to CV events or urgent heart failure visits
Measured as Events

Full Information

First Posted
June 28, 2022
Last Updated
October 18, 2023
Sponsor
Novo Nordisk A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT05442047
Brief Title
A Research Study to Look at How a New Medicine Called NNC6019-0001 Works and How Safe it is for People Who Have Heart Disease Due to Transthyretin (TTR) Amyloidosis
Official Title
Efficacy and Safety of NNC6019-0001 at Two Dose Levels in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR CM)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
May 7, 2024 (Anticipated)
Study Completion Date
February 17, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is testing a potential new medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis.The study will look at if this medicine can reduce the symptoms of a heart disease due to TTR amyloidosis, such as heart failure. Participants will either get NNC6019-0001 (apotential new medicine) or placebo (a medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting NNC6019-0001 is two times higher than getting placebo. NNC6019-0001 is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe yet. Participants will get an infusion of the study medicine 13 times, once every 4 weeks. The study will last for about 64 weeks after the first dose of medicine. Participants cannot participate in this study if they have a heart disease other than a heart disease due to TTR amyloidosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transthyretin Amyloid Cardiomyopathy (ATTR CM)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NNC6019-0001, 10 mg/kg
Arm Type
Experimental
Arm Description
Participants will receive intravenous (i.v.) infusion of 10 milligrams per kilograms (mg/kg) NNC6019-0001 every 4 weeks (Q4W) added to standard of care until week 52.
Arm Title
NNC6019-0001, 60 mg/kg
Arm Type
Experimental
Arm Description
Participants will receive i.v. infusion of 60 mg/kg NNC6019-0001 Q4W added to standard of care until week 52.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive i.v. infusion of placebo (NNC6019-0001) Q4W added to standard of care until week 52.
Intervention Type
Drug
Intervention Name(s)
NNC6019-0001
Intervention Description
Participants will receive i.v infusionof NNC6019-0001.
Intervention Type
Drug
Intervention Name(s)
Placebo (NNC6019-0001)
Intervention Description
Participants will receive i.v. infusion of placebo (NNC6019-0001).
Primary Outcome Measure Information:
Title
Change in 6-minute walk test (6-MWT)
Description
Measured in Meters
Time Frame
From baseline (week 0) to visit 15 (week 52)
Title
Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)
Description
Measured in Percentage
Time Frame
From baseline (week 0) to visit 15 (week 52)
Secondary Outcome Measure Information:
Title
Change in myocardial extracellular volume (ECV)
Description
Measured in Percentage (%)-points
Time Frame
From baseline (week 0) to visit 15 (week 52)
Title
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)
Description
The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Time Frame
From baseline (week 0) to visit 15 (week 52)
Title
Change in neuropathy impairment score (NIS)
Description
NIS is a clinical assessment that tests muscle strength, reflex activity, and sensation of toes and fingers, and can be used to assess neurologic function in hereditary transthyretin amyloid (hATTR). The total NIS score is graded on a scale of 0-244, with a higher score indicating greater impairment.
Time Frame
From baseline (week 0) to visit 15 (week 52)
Title
Change in troponin I
Description
Measured in nanogram per milliliter (ng/mL)
Time Frame
From baseline (week 0) to visit 15 (week 52)
Title
Change in global longitudinal strain (GLS) on echocardiography
Description
Measured in Percentage (%)-points
Time Frame
From baseline (week 0) to visit 15 (week 52)
Title
Number of treatment emergent adverse events
Description
Measured as Events
Time Frame
From baseline (week 0) to visit 16 (week 64)
Title
Time to occurrence of all-cause mortality
Description
Measured in Weeks
Time Frame
From baseline (week 0) to visit 16 (week 64)
Title
Number of cardiovascular (CV) events comprising hospitalisation due to CV events or urgent heart failure visits
Description
Measured as Events
Time Frame
From baseline (week 0) to visit 16 (week 64)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female. Age greater than or equal to (>=) 18 to less than (<) 85 years at the time of signing informed consent. Have an established diagnosis of Transthyretin amyloid cardiomyopathy (ATTR CM) with either wild-type transhyretin (TTR) or hereditary transthyretin (TTR) genotype as per local standards. Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the randomisation visit. Known end-diastolic interventricular septal wall thickness greater than or equal to (>=) 12 millimeters (mm). Presently classified as New York Heart Association (NYHA) Class II-III. N-terminal-pro brain natriuretic peptide (NT-proBNP) concentration greater than or equal to (>=) 650 picograms per milliliter (pg/mL) in sinus cardiac rhythm and greater than (>) 1000 pg/mL in atrial fibrillation at screening. Completed greater than or equal to (>=) 150 meters to less than or equal to (<=) 450 meters on the 6-minute walk test (MWT) at screening. Estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 25 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2) at screening. Exclusion Criteria: Cardiomyopathy not primarily caused by transthyretin amyloid cardiomyopathy transthyretin amyloid cardiomyopathy (ATTR CM), for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease. A prior solid organ transplant. Planned solid organ transplant during the study. Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, insitu carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before screening. Current treatment with calcium channel blockers with conduction system effects (example [e.g.], verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response. Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularization, cardiac valve repair, or major surgery within 3 months of screening. Body weight >120 kilogram (kg) (264.6 pounds [lb]) at screening. History of contrast allergy or adverse reactions to gadolinium-containing agents.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency 2834
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-4501
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-4501
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Toulouse Cedex 9 TSA 50032
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Würzburg
ZIP/Postal Code
97078
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Würzburg
ZIP/Postal Code
97078
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Pisa
State/Province
Pi
ZIP/Postal Code
56124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Fukuoka
ZIP/Postal Code
807-8556
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Kumamoto-shi, Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Okayama-shi, Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Vila Real
ZIP/Postal Code
5000-508
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

A Research Study to Look at How a New Medicine Called NNC6019-0001 Works and How Safe it is for People Who Have Heart Disease Due to Transthyretin (TTR) Amyloidosis

We'll reach out to this number within 24 hrs