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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04788511

Collaborator

(none)

516

Enrollment

Locations

Arms

25.3

Anticipated Duration (Months)

5.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Semaglutide Drug: Placebo (semaglutide)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

516 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 16, 2021

Anticipated Primary Completion Date :

Mar 15, 2023

Anticipated Study Completion Date :

Apr 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Semaglutide 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.	Drug: Semaglutide 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.
Placebo Comparator: Placebo (semaglutide) 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.	Drug: Placebo (semaglutide) 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.

Arm

Intervention/Treatment

Experimental: Semaglutide

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.

Drug: Semaglutide

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.

Placebo Comparator: Placebo (semaglutide)

Drug: Placebo (semaglutide)

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.

Outcome Measures

Primary Outcome Measures

Change in KCCQ (Kansas City Cardiomyopathy Questionnaire ) clinical summary score [From baseline (week 0) to end of treatment (week 52)]
Score (no unit, range; 0-100 where the score 100 means the least burden for the participant)
Change in body weight [From baseline (week 0) to end of treatment (week 52)]
Percentage

Secondary Outcome Measures

Change in C-Reactive Protein (CRP) [From baseline (week -2) to end of treatment (week 52)]
Ratio to baseline (no unit)
Change in six-minute walking distance [From baseline (week 0) to end of treatment (week 52]
Metres
Subject achieving 10 percentage weight loss or more (Yes/No) [From baseline (week 0) to end of treatment (week 52)]
Count of subjects
Subject achieving 15 percentage weight loss or more (Yes/No) [From baseline (week 0) to end of treatment (week 52)]
Count of subjects
Subject improving 5 points or more in KCCQ clinical summary score (Yes/No) [From baseline (week 0) to end of treatment (week 52)]
Count of subjects
Subject improving 10 points or more in KCCQ clinical summary score (Yes/No) [From baseline (week 0) to end of treatment (week 52)]
Count of subjects
Change in KCCQ overall summary score [From baseline (week 0) to end of treatment (week 52)]
Score (no unit, range; 0-100 where the score 100 means the least burden for the participant)
Change in systolic blood pressure (SBP) [From baseline (week -2) to end of treatment (week 52)]
mmHg
Change in waist circumference [From baseline (week 0) to end of treatment (visit 52)]
cm

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Fairhope	Alabama	United States	36532
2	Novo Nordisk Investigational Site	Los Angeles	California	United States	90033
3	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32258
4	Novo Nordisk Investigational Site	Arlington Heights	Illinois	United States	60005
5	Novo Nordisk Investigational Site	Chicago	Illinois	United States	60611
6	Novo Nordisk Investigational Site	Hazel Crest	Illinois	United States	60429
7	Novo Nordisk Investigational Site	Indianapolis	Indiana	United States	46260-1992
8	Novo Nordisk Investigational Site	Kansas City	Kansas	United States	66160
9	Novo Nordisk Investigational Site	Topeka	Kansas	United States	66606
10	Novo Nordisk Investigational Site	Lexington	Kentucky	United States	40503
11	Novo Nordisk Investigational Site	Louisville	Kentucky	United States	40207
12	Novo Nordisk Investigational Site	Bossier City	Louisiana	United States	71111
13	Novo Nordisk Investigational Site	Hammond	Louisiana	United States	70403
14	Novo Nordisk Investigational Site	Shreveport	Louisiana	United States	71105
15	Novo Nordisk Investigational Site	Slidell	Louisiana	United States	70458
16	Novo Nordisk Investigational Site	Baltimore	Maryland	United States	21287
17	Novo Nordisk Investigational Site	Rochester	Minnesota	United States	55902
18	Novo Nordisk Investigational Site	Jackson	Mississippi	United States	39216
19	Novo Nordisk Investigational Site	Kansas City	Missouri	United States	64111
20	Novo Nordisk Investigational Site	Saint Louis	Missouri	United States	63136
21	Novo Nordisk Investigational Site	Lincoln	Nebraska	United States	68506
22	Novo Nordisk Investigational Site	Omaha	Nebraska	United States	68124
23	Novo Nordisk Investigational Site	New York	New York	United States	10021
24	Novo Nordisk Investigational Site	Roslyn	New York	United States	11576
25	Novo Nordisk Investigational Site	Winston-Salem	North Carolina	United States	27157
26	Novo Nordisk Investigational Site	Cincinnati	Ohio	United States	45219
27	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19104
28	Novo Nordisk Investigational Site	Dallas	Texas	United States	75390
29	Novo Nordisk Investigational Site	Falls Church	Virginia	United States	22042
30	Novo Nordisk Investigational Site	Caba		Argentina	C1119ACN
31	Novo Nordisk Investigational Site	Caba		Argentina	C1440CFD
32	Novo Nordisk Investigational Site	Ciudad Autónoma de Buenos Aire		Argentina	1425
33	Novo Nordisk Investigational Site	Corrientes		Argentina	W3400AMZ
34	Novo Nordisk Investigational Site	Morón		Argentina	B1708IFF
35	Novo Nordisk Investigational Site	Rosario, Santa Fe		Argentina	S2000CVB
36	Novo Nordisk Investigational Site	Garran	Australian Capital Territory	Australia	2605
37	Novo Nordisk Investigational Site	Concord	New South Wales	Australia	2139
38	Novo Nordisk Investigational Site	Liverpool	New South Wales	Australia	2170
39	Novo Nordisk Investigational Site	Bedford Park	South Australia	Australia	5042
40	Novo Nordisk Investigational Site	Geelong	Victoria	Australia	3220
41	Novo Nordisk Investigational Site	Cambridge	Ontario	Canada	N1R 6V6
42	Novo Nordisk Investigational Site	Newmarket	Ontario	Canada	L3Y 2P6
43	Novo Nordisk Investigational Site	Oakville	Ontario	Canada	L6K 3W7
44	Novo Nordisk Investigational Site	Oshawa	Ontario	Canada	L1J 2K1
45	Novo Nordisk Investigational Site	Scarborough	Ontario	Canada	M1B 4Z8
46	Novo Nordisk Investigational Site	Toronto	Ontario	Canada	M9N 1W4
47	Novo Nordisk Investigational Site	Quebec		Canada	G1V 4G5
48	Novo Nordisk Investigational Site	Jihlava		Czechia	586 33
49	Novo Nordisk Investigational Site	Praha 2		Czechia	128 00
50	Novo Nordisk Investigational Site	Praha 4		Czechia	140 21
51	Novo Nordisk Investigational Site	Praha 7		Czechia	170 00
52	Novo Nordisk Investigational Site	Slany		Czechia	274 01
53	Novo Nordisk Investigational Site	Tábor		Czechia	390 03
54	Novo Nordisk Investigational Site	Aarhus N		Denmark	8200
55	Novo Nordisk Investigational Site	Hellerup		Denmark	2900
56	Novo Nordisk Investigational Site	Svendborg		Denmark	5700
57	Novo Nordisk Investigational Site	Berlin		Germany	13353
58	Novo Nordisk Investigational Site	Dresden		Germany	01277
59	Novo Nordisk Investigational Site	Elsterwerda		Germany	04910
60	Novo Nordisk Investigational Site	Frankfurt		Germany	60389
61	Novo Nordisk Investigational Site	Freiburg		Germany	79106
62	Novo Nordisk Investigational Site	Kassel		Germany	34121
63	Novo Nordisk Investigational Site	Würzburg		Germany	97078
64	Novo Nordisk Investigational Site	Baja		Hungary	6500
65	Novo Nordisk Investigational Site	Budapest		Hungary	1032
66	Novo Nordisk Investigational Site	Budapest		Hungary	1085
67	Novo Nordisk Investigational Site	Budapest		Hungary	1096
68	Novo Nordisk Investigational Site	Budapest		Hungary	1122
69	Novo Nordisk Investigational Site	Budapest		Hungary	1204
70	Novo Nordisk Investigational Site	Komárom		Hungary	2921
71	Novo Nordisk Investigational Site	Miskolc		Hungary	3526
72	Novo Nordisk Investigational Site	Zalaegerszeg		Hungary	8900
73	Novo Nordisk Investigational Site	Tel Aviv		Israel	6423906
74	Novo Nordisk Investigational Site	Tel Hashomer		Israel	5265601
75	Novo Nordisk Investigational Site	Apeldoorn		Netherlands	7334 DZ
76	Novo Nordisk Investigational Site	Beverwijk		Netherlands	1942 LE
77	Novo Nordisk Investigational Site	Groningen		Netherlands	9713 GZ
78	Novo Nordisk Investigational Site	Hardenberg		Netherlands	7772 SE
79	Novo Nordisk Investigational Site	Leeuwarden		Netherlands	8934 AD
80	Novo Nordisk Investigational Site	Roosendaal		Netherlands	4708 AE
81	Novo Nordisk Investigational Site	Bialystok		Poland	15-276
82	Novo Nordisk Investigational Site	Chrzanow		Poland	32-500
83	Novo Nordisk Investigational Site	Gdynia		Poland	81-157
84	Novo Nordisk Investigational Site	Katowice		Poland	40-648
85	Novo Nordisk Investigational Site	Lodz		Poland	90-549
86	Novo Nordisk Investigational Site	Warsaw		Poland	02-097
87	Novo Nordisk Investigational Site	Madrid		Spain	28023
88	Novo Nordisk Investigational Site	Santiago de Compostela		Spain	15706
89	Novo Nordisk Investigational Site	Valencia		Spain	46010
90	Novo Nordisk Investigational Site	Bristol		United Kingdom	BS10 5NB
91	Novo Nordisk Investigational Site	Dundee		United Kingdom	DD1 9SY
92	Novo Nordisk Investigational Site	Glasgow		United Kingdom	G31 2ER
93	Novo Nordisk Investigational Site	Glasgow		United Kingdom	G51 4TF
94	Novo Nordisk Investigational Site	High Wycombe		United Kingdom	HP11 2TT
95	Novo Nordisk Investigational Site	Liverpool		United Kingdom	L9 7AL
96	Novo Nordisk Investigational Site	Manchester		United Kingdom	M13 9WL
97	Novo Nordisk Investigational Site	Swindon		United Kingdom	SN3 6BB
98	Novo Nordisk Investigational Site	West Sussex		United Kingdom	PO19 6SE

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT04788511

Other Study ID Numbers:

EX9536-4665
U1111-1243-4358
2019-004452-11

First Posted:

Mar 9, 2021

Last Update Posted:

Jun 16, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Failure

Obesity

Study Results

No Results Posted as of Jun 16, 2022