臨床研究等提出・公開システム

Japanese

Date of registration	June. 17, 2021
Last modified on	Dec. 15, 2023
Trial ID	jRCT2061210014

Scientific 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(EX9536-4773) (STEP HFpEF DM)
Public 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 (STEP HFpEF DM)

Contact for Scientific Queries	Name	Kinoshita Kazunori
	Affiliation	Novo Nordisk Pharma Ltd.
	Address	2-1-1, Marunouchi, Chiyodaku, Tokyo
	Telephone	+81-362661000
	E-mail	JPHC_clinical_trials@novonordisk.com
Contact for Public Queries	Name	Kinoshita Kazunori
	Affiliation	Novo Nordisk Pharma Ltd.
	Address	2-1-1, Marunouchi, Chiyodaku, Tokyo
	Telephone	+81-362661000
	E-mail	JPHC_clinical_trials@novonordisk.com

Recruitment status	Complete

Anticipated date of first enrollment		June. 15, 2021
Actual date of first enrollment		June. 15, 2021
Target sample size		610
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	-Male or female, age above or equal to 20 years at the time of signing informed consent. -Body mass index (BMI) >=30.0 kg/m2 -New York Heart Association (NYHA) Class II-IV -Left ventricular ejection fraction (LVEF) >= 45% at screening -Diagnosed with T2D >= 90 days prior to the day of screening -HbA1c of <= 10.0% as measured at the screening visit
	Exclusion Criteria	-A self-reported change in body weight > 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.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Type2 diabetes and obesity-related heart failure with preserved ejection fraction
Intervention(s)		semaglutide subcutaneous (s.c.) 2.4 mg once-weekly added to standard of care
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Multiple primary endpoints -Change in KCCQ clinical summary -score (no unit, range; 0-100) From baseline (week 0) to end of treatment (week 52) -Change in body weight (%) From baseline (week 0) to end of treatment (week 52)
Secondary Outcome(s)

Primary Sponsor	Novo Nordisk Pharma Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Okayama University Hospital IRB
Address	2-5-1 Shikata-cho, Kita-ku,Okayama-shi, Okayama
Telephone	+81-86-235-7534
E-Mail	chiken@okayama-u.ac.jp
Approval Status	Approval
Date of approval	April. 27, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT04916470
Issuing Authority	Clinical Trials.gov

Countries of Recruitment（Except Japan）	Argentina/Austria/Canada/Germany/Hungary/India/Israel/Italy/Japan/Netherlands/Poland/Spain/Sweden/United Kingdom/United States

History of Changes

No	Publication date
3	Dec. 15, 2023	(this page)	Changes
2	June. 24, 2023	Detail	Changes
1	June. 17, 2021	Detail

List of change history