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Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes (STEP HFpEF DM)

Primary Purpose

Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Semaglutide
Placebo (Semaglutide)
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female, age above or equal to 18 years at the time of signing informed consent.
  • Body mass index (BMI) greater than or equal to 30.0 kg/m^2
  • New York Heart Association (NYHA) Class II-IV
  • Left ventricular ejection fraction (LVEF) greater than or equal to 45% at screening
  • Diagnosed with T2D greater than or equal to 90 days prior to the day of screening
  • HbA1c of below or equal to 10.0% as measured at the screening visit

Exclusion Criteria:

  • A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Sites / Locations

  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Semaglutide 2.4 mg once weekly (OW)

Semaglutide placebo OW

Arm Description

Participants will receive semaglutide injections for 52 weeks.

Participants will receive semaglutide placebo injections for 52 weeks.

Outcomes

Primary Outcome Measures

Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score
Score on a scale of 0 to 100 where the score 100 means the least burden for the participant.
Change in body weight
Percentage (%)

Secondary Outcome Measures

Change in 6-minute walking distance
Measured in metres
Hierarchical composite of time to all-cause death
Measured as total wins for each treatment group.
Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit
Measured as total wins for each treatment group
Hierarchical composite of time to first heart failure event requiring hospitalisation or urgent heart failure visit
Measured as total wins for each treatment group.
Hierarchical composite of difference at least 15 inKansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score change from baseline to 52 weeks
Measured as total wins for each treatment group.
Hierarchical composite of difference at least 10 in KCCQ clinical summary score change from baseline to 52 weeks
Measured as total wins for each treatment group.
Hierarchical composite of difference at least 5 in KCCQ clinical summary score change from baseline to 52 weeks
Measured as total wins for each treatment group.
Hierarchical composite of difference at least 30 metres in six-minute walking distance change from baseline to 52 weeks (assessed by the win ratio)
Measured as total wins for each treatment group.
Change in C-Reactive Protein
Presented as ratio to baseline
Participant achieving 10% weight loss or more (Yes/No)
Count of participants
Participant achieving 15% weight loss or more (Yes/No)
Count of participants
Participant achieving 20% weight loss or more (Yes/No)
Count of participants
Participant improving 5 points or more in KCCQ clinical summary score
Count of participants
Participant improving 10 points or more in KCCQ clinical summary score (Yes/No)
Count of participants
Change in KCCQ overall summary score
Score on a scale of 0 to 100 where the score 100 means the least burden for the participant.
Participant achieving threshold for clinically meaningful within-subject change in KCCQ-CSS
Count of participants
Participant achieving threshold for clinically meaningful within-subject change in 6MWD
Count of participants
Change in waist circumference
Measured in centimetre (cm)
Change in systolic blood pressure
Measured in millimetre of mercury (mmHg)
Change in glycated haemoglobin (HbA1c)
Measured in percentage (%)-point
Number of treatment emergent severe or clinically significant hypoglycaemia episodes
Count of events

Full Information

First Posted
June 1, 2021
Last Updated
October 18, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04916470
Brief Title
Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes
Acronym
STEP HFpEF DM
Official Title
Effect of Semaglutide 2.4 mg Once-weekly on Function and Symptoms in Subjects With Obesity-related Heart Failure With Preserved Ejection Fraction, and Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
October 13, 2023 (Anticipated)
Study Completion Date
October 13, 2023 (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
No

5. Study Description

Brief Summary
This study will look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight. This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms. Participants will either get semaglutide or "dummy" medicine, which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm. During the study participants will have talks with the study staff about healthy lifestyle and physical activity. The study will last for about 59 weeks, that is a little more than 1 year. Participants will have 12 clinic visits with the study doctor. At 6 of the visits participants will have blood samples taken. At 5 of the visits participants will be asked to fill in a questionnaire At 4 of the visits participants will have to do a 6-minute walking test At 3 of the visits participants will have a test to check the heart. participants will have their eyes checked before or at the start of the study and at the end of the study Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
610 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Semaglutide 2.4 mg once weekly (OW)
Arm Type
Experimental
Arm Description
Participants will receive semaglutide injections for 52 weeks.
Arm Title
Semaglutide placebo OW
Arm Type
Placebo Comparator
Arm Description
Participants will receive semaglutide placebo injections for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly for 52 weeks. Dose will be gradually increased to 2.4 mg: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 52.
Intervention Type
Drug
Intervention Name(s)
Placebo (Semaglutide)
Intervention Description
Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly for 52 weeks.
Primary Outcome Measure Information:
Title
Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score
Description
Score on a scale of 0 to 100 where the score 100 means the least burden for the participant.
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Change in body weight
Description
Percentage (%)
Time Frame
From baseline (week 0) to end of treatment (week 52)
Secondary Outcome Measure Information:
Title
Change in 6-minute walking distance
Description
Measured in metres
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Hierarchical composite of time to all-cause death
Description
Measured as total wins for each treatment group.
Time Frame
From baseline (week 0) to end of study (week 57)
Title
Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit
Description
Measured as total wins for each treatment group
Time Frame
From baseline (week 0) to end of study (week 57)
Title
Hierarchical composite of time to first heart failure event requiring hospitalisation or urgent heart failure visit
Description
Measured as total wins for each treatment group.
Time Frame
From baseline (week 0) to end of study (week 57)
Title
Hierarchical composite of difference at least 15 inKansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score change from baseline to 52 weeks
Description
Measured as total wins for each treatment group.
Time Frame
From baseline (week 0) to end of study (week 57)
Title
Hierarchical composite of difference at least 10 in KCCQ clinical summary score change from baseline to 52 weeks
Description
Measured as total wins for each treatment group.
Time Frame
From baseline (week 0) to end of study (week 57)
Title
Hierarchical composite of difference at least 5 in KCCQ clinical summary score change from baseline to 52 weeks
Description
Measured as total wins for each treatment group.
Time Frame
From baseline (week 0) to end of study (week 57)
Title
Hierarchical composite of difference at least 30 metres in six-minute walking distance change from baseline to 52 weeks (assessed by the win ratio)
Description
Measured as total wins for each treatment group.
Time Frame
From baseline (week 0) to end of study (week 57)
Title
Change in C-Reactive Protein
Description
Presented as ratio to baseline
Time Frame
From baseline (week -2) to end of treatment (week 52)
Title
Participant achieving 10% weight loss or more (Yes/No)
Description
Count of participants
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Participant achieving 15% weight loss or more (Yes/No)
Description
Count of participants
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Participant achieving 20% weight loss or more (Yes/No)
Description
Count of participants
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Participant improving 5 points or more in KCCQ clinical summary score
Description
Count of participants
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Participant improving 10 points or more in KCCQ clinical summary score (Yes/No)
Description
Count of participants
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Change in KCCQ overall summary score
Description
Score on a scale of 0 to 100 where the score 100 means the least burden for the participant.
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Participant achieving threshold for clinically meaningful within-subject change in KCCQ-CSS
Description
Count of participants
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Participant achieving threshold for clinically meaningful within-subject change in 6MWD
Description
Count of participants
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Change in waist circumference
Description
Measured in centimetre (cm)
Time Frame
From baseline (week 0) to end of treatment (visit 52)
Title
Change in systolic blood pressure
Description
Measured in millimetre of mercury (mmHg)
Time Frame
From baseline (week -2) to end of treatment (week 52)
Title
Change in glycated haemoglobin (HbA1c)
Description
Measured in percentage (%)-point
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Number of treatment emergent severe or clinically significant hypoglycaemia episodes
Description
Count of events
Time Frame
From baseline (week 0) to end of trial (week 57)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, age above or equal to 18 years at the time of signing informed consent. Body mass index (BMI) greater than or equal to 30.0 kg/m^2 New York Heart Association (NYHA) Class II-IV Left ventricular ejection fraction (LVEF) greater than or equal to 45% at screening Diagnosed with T2D greater than or equal to 90 days prior to the day of screening HbA1c of below or equal to 10.0% as measured at the screening visit Exclusion Criteria: A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
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 (Dept.1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Hazel Crest
State/Province
Illinois
ZIP/Postal Code
60429
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Elizabethtown
State/Province
Kentucky
ZIP/Postal Code
42701
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21239
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novo Nordisk Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-5058
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novo Nordisk Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1061AAS.
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1119ACN
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1440CFD
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Ciudad Autónoma de Buenos Aire
ZIP/Postal Code
1425
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Corrientes
ZIP/Postal Code
W3400AMZ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Morón
ZIP/Postal Code
B1708IFF
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Rosario, Santa Fe
ZIP/Postal Code
S2000CVB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Braunau
ZIP/Postal Code
A 5280
Country
Austria
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Graz
ZIP/Postal Code
A 8036
Country
Austria
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Graz
ZIP/Postal Code
A 8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Saint Stefan
ZIP/Postal Code
8511
Country
Austria
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Saint Stefan
ZIP/Postal Code
8511
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
1100
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
A 1090
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
A 1090
Country
Austria
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
A 1190
Country
Austria
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Novo Nordisk Investigational Site
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 6V6
Country
Canada
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 6V6
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Novo Nordisk Investigational Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P6
Country
Canada
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1B 4Z8
Country
Canada
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Weston
State/Province
Ontario
ZIP/Postal Code
M9N 1W4
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3T2
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Terrebonne
State/Province
Quebec
ZIP/Postal Code
J6X 4P7
Country
Canada
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Broumov
ZIP/Postal Code
550 01
Country
Czechia
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Broumov
ZIP/Postal Code
550 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Praha 7
ZIP/Postal Code
170 00
Country
Czechia
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Praha 7
ZIP/Postal Code
170 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Dresden
ZIP/Postal Code
01277
Country
Germany
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Elsterwerda
ZIP/Postal Code
04910
Country
Germany
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Novo Nordisk Investigational Site
City
Kassel
ZIP/Postal Code
34121
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Würzburg
ZIP/Postal Code
97078
Country
Germany
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Baja
State/Province
Bács-Kiskun
ZIP/Postal Code
6500
Country
Hungary
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Komárom
State/Province
Komárom-Esztergom
ZIP/Postal Code
2921
Country
Hungary
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110017
Country
India
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682018
Country
India
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422005
Country
India
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422005
Country
India
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
New Dehli
State/Province
New Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
New Dehli
State/Province
New Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bikaner
State/Province
Rajasthan
ZIP/Postal Code
334003
Country
India
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Bikaner
State/Province
Rajasthan
ZIP/Postal Code
334003
Country
India
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600006
Country
India
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
New Delhi
ZIP/Postal Code
110002
Country
India
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
New Delhi
ZIP/Postal Code
110017
Country
India
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
New Delhi
ZIP/Postal Code
110060
Country
India
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
New Delhi
ZIP/Postal Code
110060
Country
India
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Tel Hashomer
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Bergamo
State/Province
Bg
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Brescia
State/Province
Bs
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Cona (Ferrara)
State/Province
Fe
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
20138
Country
Italy
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Himeji-shi, Hyogo
ZIP/Postal Code
670-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Kitakyushu-shi,Fukuoka
ZIP/Postal Code
802-8555
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
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Omihachiman-shi, Siga
ZIP/Postal Code
523-0082
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Osaka-shi, Osaka
ZIP/Postal Code
530-8480
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
062-0003
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
140-8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Beverwijk
ZIP/Postal Code
1942 LE
Country
Netherlands
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Hardenberg
ZIP/Postal Code
7772 SE
Country
Netherlands
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Roosendaal
ZIP/Postal Code
4708 AE
Country
Netherlands
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-549
Country
Poland
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-276
Country
Poland
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Chrzanow
State/Province
Slaskie
ZIP/Postal Code
32-500
Country
Poland
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Gdynia
ZIP/Postal Code
81-157
Country
Poland
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Katowice
State/Province
Śląskie
ZIP/Postal Code
40-648
Country
Poland
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Sevilla
ZIP/Postal Code
41003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Göteborg
ZIP/Postal Code
416 50
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Jönköping
ZIP/Postal Code
551 85
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
Novo Nordisk Investigational Site
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Novo Nordisk Investigational Site
City
Glasgow
ZIP/Postal Code
G31 2ER
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Glasgow
ZIP/Postal Code
G31 2ER
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Novo Nordisk Investigational Site
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Novo Nordisk Investigational Site
City
High Wycombe
ZIP/Postal Code
HP11 2TT
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
High Wycombe
ZIP/Postal Code
HP11 2TT
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Novo Nordisk Investigational Site
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Novo Nordisk Investigational Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Novo Nordisk Investigational Site
City
Swindon
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Individual Site Status
Completed

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
Citations:
PubMed Identifier
37294245
Citation
Kosiborod MN, Abildstrom SZ, Borlaug BA, Butler J, Christensen L, Davies M, Hovingh KG, Kitzman DW, Lindegaard ML, Moller DV, Shah SJ, Treppendahl MB, Verma S, Petrie MC. Design and Baseline Characteristics of STEP-HFpEF Program Evaluating Semaglutide in Patients With Obesity HFpEF Phenotype. JACC Heart Fail. 2023 Aug;11(8 Pt 1):1000-1010. doi: 10.1016/j.jchf.2023.05.010. Epub 2023 May 21.
Results Reference
background

Learn more about this trial

Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes

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