臨床研究等提出・公開システム

Date of registration	Nov. 25, 2022
Last modified on	Sept. 27, 2023
Trial ID	jRCT2051220121

Scientific Title	Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants with overweight or obesity (REDEFINE 1)
Public Title	Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants with overweight or obesity (REDEFINE 1)

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

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Nov. 07, 2022
Actual date of first enrollment		Nov. 07, 2022
Target sample size		250
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	BMI >= 30.0 kg/m2 or b) BMI >= 27.0 kg/m2 with the presence of at least one weight related comorbidity including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
	Exclusion Criteria	History of type 1 or type 2 diabetes mellitus
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Obesity
Intervention(s)		The trial is an interventional 68-week (main phase) randomised, double-blind, placebo- and active-controlled, four arm, parallel group, multicentre, multinational clinical study comparing CagriSema s.c.2.4mg/2.4 mg once-weekly with semaglutide s.c. 2.4 mg and cagrilintide s.c. 2.4 mg and placebo, all as an adjunct to a reduced-calorie diet and increased physical activity, in participants with overweight or obesity. The study will also include a 97-week two arm, off-treatment extension phase.
Primary Outcome(s)		Change from baseline in body weight (%)

Primary Sponsor	Novo Nordisk Pharma Ltd.

Name of Certified Review Board	Medical Corporation Heishinkai OPHAC Hospital IRB
Address	4-1-29, Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Telephone	+81-6-6395-9000
Approval Status	Approval
Date of approval	Sept. 09, 2022

Plan to share IPD	No

Secondary ID(s)	NCT05567796
Issuing Authority	Clinical Trials.gov

Countries of Recruitment（Except Japan）	Argentina/Belgium/Bulgaria/Canada/Denmark/Finland/France/Germany/Japan/Mexico/Netherlands/South Korea/Spain/Taiwan/Turkey/United Kingdom/United States/Australia/India/Italy/Poland/Russia/Serbia/South Africa

History of Changes

No	Publication date
2	Sept. 27, 2023	(this page)	Changes
1	Nov. 25, 2022	Detail

List of change history