臨床研究等提出・公開システム

Date of registration	Aug. 24, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220827

Scientific Title	-
Public Title	A phase III study of ATL-962 in subject with obesity

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Takeda Pharmaceutical Company Limited
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Takeda Pharmaceutical Company Limited
	Address	https://www.takeda.co.jp/contact/form/en/form/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Open-label, multi-center study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	1.Inpatient/Outpatient status during the run-in period: Outpatient 2.The subject who is capable of providing consent to participate in this study, with ability to read and understand the informed consent form and other written information, etc.
	Exclusion Criteria	1.The subject with serious cardiac disease, cerebrovascular disorder, or serious pancreatic or hematological disease, etc. 2.The subject who is considered ineligible to participate in the study by the investigator or subinvestigator, etc.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Obesity
Intervention(s)		investigational material(s) Generic name etc : ATL-962 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Oral administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	Takeda Pharmaceutical Company Limited
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-090858
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Feb. 24, 2014	Detail	Changes
5	Dec. 17, 2013	Detail	Changes
4	Oct. 11, 2011	Detail	Changes
3	Sept. 13, 2010	Detail	Changes
2	Sept. 14, 2009	Detail	Changes
1	Aug. 24, 2009	Detail

List of change history