臨床研究等提出・公開システム

Date of registration	Mar. 23, 2026
Last modified on	June. 10, 2026
Trial ID	jRCT2031250828

Scientific Title	Efficacy and Safety of Once-weekly Subcutaneous NNC0662-0419 in Participants With Type 2 Diabetes - a Dose-finding Study(NN9662-8160) (NA)
Public Title	A research study comparing how well different doses of the medicine NNC0662-0419 lower blood sugar in people with type 2 diabetes (NA)

Contact for Scientific Queries	Name	Miku Fukunaga
	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	Clinical trail information Administorator
	Affiliation	Novo Nordisk Pharma Ltd.
	Address	2-1-1, Marunouchi, Chiyodaku, Tokyo
	Telephone	+81-362661000
	E-mail	JPHC_clinical_trials@novonordisk.com

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 17, 2026
Target sample size		25
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 (sex at birth). -Age 18-75 years (both inclusive) at the time of signing the informed consent. -Glycated haemoglobin (HbA1c) of 7.0-10.0 percent (%) (53-86 millimoles per mole [mmol/mol]) (both inclusive) as assessed by central laboratory at screening. -Willingness to obtain a high weight loss (greater than [>] 25% of weight at baseline).
	Exclusion Criteria	-Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed. -Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. -Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's Questionnaire.
	Age Minimum	18age old over
	Age Maximum	75age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Type 2 diabetes
Intervention(s)		Drug: NNC0662-0419 NNC0662-0419 will be administered subcutaneously. Drug: Semaglutide Semaglutide will be administered subcutaneously. Drug: Placebo Placebo will be administered subcutaneously.
Primary Outcome(s)		-Change in glycated haemoglobin (HbA1c) (week 16) [Time Frame: From baseline (week 0) to week 16]-Measured as percentage-point (%-point). -Change in HbA1c (week 28) [Time Frame: From baseline (week 0) to week 28]-Measured as %-point. -Change in HbA1c (week 40) [Time Frame: From baseline (week 0) to week 40]-Measured as %-point.

Primary Sponsor	Novo Nordisk Pharma Ltd.

Name of Certified Review Board	Polaris Institutional Review Board
Address	4-4-16-301, Hon-cho, Kawaguchi-shi, Saitama
Telephone	+81-42-648-5551
E-Mail	polaris-irb@eps.co.jp
Date of approval	Feb. 27, 2023

Plan to share IPD	Yes
Plan description	According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Secondary ID(s)	NCT07415954
Issuing Authority	Clinical Trials.gov

Countries of Recruitment（Except Japan）	United States/Croatia/Thailand/Poland/Portugal/Slovakia/South Korea/Spain

History of Changes

No	Publication date
3	June. 10, 2026	(this page)	Changes
2	Mar. 24, 2026	Detail	Changes
1	Mar. 23, 2026	Detail

List of change history