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Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity (STEP-HFpEF)

Primary Purpose

Obesity

Status
Completed
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 Obesity

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 percentage at screening

Exclusion Criteria:

  • A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
  • Haemoglobin A1c (HbA1c) greater than or equal to 6.5 percentage (48 mmol/mol) based on latest available value from medical records, no older than 3 months or if unavailable a local measurement at screening

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Semaglutide

Placebo (semaglutide)

Arm Description

All participants will receive either semaglutide 2.4 mg once weekly or placebo once weekly as add-on to standard of care. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose.

All participants will receive either semaglutide 2.4 mg once weekly or placebo once weekly as add-on to standard of care. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose.

Outcomes

Primary Outcome Measures

Change in KCCQ (Kansas City Cardiomyopathy Questionnaire ) clinical summary score
Score (no unit, range; 0-100 where the score 100 means the least burden for the participant)
Change in body weight
Percentage

Secondary Outcome Measures

Change in six-minute walking distance
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.
Hierarchial composite of time to first heart failure event requiring hospitalisation or urgent heart failure visit
Measured as total wins for each treatment group.
Hierarchial composite of difference at least 15 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 10 in KCCQ clinical summary score change from baseline to 52 weeks
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 (CRP)
Ratio to baseline (no unit)
Subject achieving 10 percentage weight loss or more (Yes/No)
Count of subjects
Subject achieving 15 percentage weight loss or more (Yes/No)
Count of subjects
Subject achieving 20 percentage weight loss or more (Yes/No)
Count of subjects
Subject improving 5 points or more in KCCQ clinical summary score (Yes/No)
Count of subjects
Subject improving 10 points or more in KCCQ clinical summary score (Yes/No)
Count of subjects
Change in KCCQ overall summary score
Score (no unit, range; 0-100 where the score 100 means the least burden for the participant)
Subject achieving threshold for clinically meaningful within-subject change in KCCQ-CSS
Count of subjects
Subject achieving threshold for clinically meaningful within-subject change in 6MWD
Count of subjects
Change in systolic blood pressure (SBP)
mmHg
Change in waist circumference
cm

Full Information

First Posted
March 5, 2021
Last Updated
September 6, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04788511
Brief Title
Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity
Acronym
STEP-HFpEF
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
April 18, 2023 (Actual)
Study Completion Date
April 18, 2023 (Actual)

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 the participants daily life is affected by their heart failure. The study will also look at the change in participants body weight from the start to the end of the study. This is to compare the effect on heart failure symptoms and on body weight in people taking semaglutide (a new medicine) to people taking "dummy" medicine. 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 choices including healthy food and physical activity. The study will last for approximately 59 weeks. Participants will have 11 clinic visits and 1 phone call with the study doctor. Women: Women cannot take part if they are 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
Obesity

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Semaglutide
Arm Type
Experimental
Arm Description
All participants will receive either semaglutide 2.4 mg once weekly or placebo once weekly as add-on to standard of care. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose.
Arm Title
Placebo (semaglutide)
Arm Type
Placebo Comparator
Arm Description
All participants will receive either semaglutide 2.4 mg once weekly or placebo once weekly as add-on to standard of care. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Dose gradually escalated from 0.25 mg until target dose. The study will last for approximately 59 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo (semaglutide)
Intervention Description
Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. The study will last for approximately 59 weeks.
Primary Outcome Measure Information:
Title
Change in KCCQ (Kansas City Cardiomyopathy Questionnaire ) clinical summary score
Description
Score (no unit, range; 0-100 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 six-minute walking distance
Description
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
Hierarchial 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
Hierarchial composite of difference at least 15 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 10 in KCCQ clinical summary score change from baseline to 52 weeks
Description
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 (CRP)
Description
Ratio to baseline (no unit)
Time Frame
From baseline (week -2) to end of treatment (week 52)
Title
Subject achieving 10 percentage weight loss or more (Yes/No)
Description
Count of subjects
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Subject achieving 15 percentage weight loss or more (Yes/No)
Description
Count of subjects
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Subject achieving 20 percentage weight loss or more (Yes/No)
Description
Count of subjects
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Subject improving 5 points or more in KCCQ clinical summary score (Yes/No)
Description
Count of subjects
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Subject improving 10 points or more in KCCQ clinical summary score (Yes/No)
Description
Count of subjects
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Change in KCCQ overall summary score
Description
Score (no unit, range; 0-100 where the score 100 means the least burden for the participant)
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Subject achieving threshold for clinically meaningful within-subject change in KCCQ-CSS
Description
Count of subjects
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Subject achieving threshold for clinically meaningful within-subject change in 6MWD
Description
Count of subjects
Time Frame
From baseline (week 0) to end of treatment (week 52)
Title
Change in systolic blood pressure (SBP)
Description
mmHg
Time Frame
From baseline (week -2) to end of treatment (week 52)
Title
Change in waist circumference
Description
cm
Time Frame
From baseline (week 0) to end of treatment (visit 52)

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 percentage at screening Exclusion Criteria: A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records Haemoglobin A1c (HbA1c) greater than or equal to 6.5 percentage (48 mmol/mol) based on latest available value from medical records, no older than 3 months or if unavailable a local measurement at screening
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
Facility Name
Novo Nordisk Investigational Site
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hazel Crest
State/Province
Illinois
ZIP/Postal Code
60429
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greenvale
State/Province
New York
ZIP/Postal Code
11548
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1061AAS.
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1119ACN
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1440CFD
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Ciudad Autónoma de Buenos Aire
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Corrientes
ZIP/Postal Code
W3400AMZ
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Morón
ZIP/Postal Code
B1708IFF
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Rosario, Santa Fe
ZIP/Postal Code
S2000CVB
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 6V6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1B 4Z8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha 2
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha 7
ZIP/Postal Code
170 00
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Tábor
ZIP/Postal Code
390 03
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Hellerup
State/Province
Region Hovedstaden
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Dresden
ZIP/Postal Code
01277
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Elsterwerda
ZIP/Postal Code
04910
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Kassel
ZIP/Postal Code
34121
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Würzburg
ZIP/Postal Code
97078
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Baja
State/Province
Bács-Kiskun
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Komárom
State/Province
Komárom-Esztergom
ZIP/Postal Code
2921
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Tel Hashomer
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Beverwijk
ZIP/Postal Code
1942 LE
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Hardenberg
ZIP/Postal Code
7772 SE
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Roosendaal
ZIP/Postal Code
4708 AE
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-549
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Chrzanow
ZIP/Postal Code
32-500
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Gdynia
ZIP/Postal Code
81-157
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Katowice
State/Province
Śląskie
ZIP/Postal Code
40-648
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28023
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Glasgow
ZIP/Postal Code
G31 2ER
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
High Wycombe
ZIP/Postal Code
HP11 2TT
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Swindon
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
West Sussex
ZIP/Postal Code
PO19 6SE
Country
United Kingdom

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
37635157
Citation
Borlaug BA, Kitzman DW, Davies MJ, Rasmussen S, Barros E, Butler J, Einfeldt MN, Hovingh GK, Moller DV, Petrie MC, Shah SJ, Verma S, Abhayaratna W, Ahmed FZ, Chopra V, Ezekowitz J, Fu M, Ito H, Lelonek M, Melenovsky V, Nunez J, Perna E, Schou M, Senni M, van der Meer P, Von Lewinski D, Wolf D, Kosiborod MN. Semaglutide in HFpEF across obesity class and by body weight reduction: a prespecified analysis of the STEP-HFpEF trial. Nat Med. 2023 Sep;29(9):2358-2365. doi: 10.1038/s41591-023-02526-x. Epub 2023 Aug 27.
Results Reference
background
PubMed Identifier
37622681
Citation
Kosiborod MN, Abildstrom SZ, Borlaug BA, Butler J, Rasmussen S, Davies M, Hovingh GK, Kitzman DW, Lindegaard ML, Moller DV, Shah SJ, Treppendahl MB, Verma S, Abhayaratna W, Ahmed FZ, Chopra V, Ezekowitz J, Fu M, Ito H, Lelonek M, Melenovsky V, Merkely B, Nunez J, Perna E, Schou M, Senni M, Sharma K, Van der Meer P, von Lewinski D, Wolf D, Petrie MC; STEP-HFpEF Trial Committees and Investigators. Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity. N Engl J Med. 2023 Sep 21;389(12):1069-1084. doi: 10.1056/NEJMoa2306963. Epub 2023 Aug 25.
Results Reference
result

Learn more about this trial

Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity

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