臨床研究等提出・公開システム

Date of registration	July. 08, 2019
Last modified on	Dec. 08, 2022
Trial ID	jRCT1080224771

Scientific Title	A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Comparison, Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of SCO-792 in Subjects with Obese Type 2 Diabetes Mellitus on Metformin Monotherapy
Public Title	SCO-792 Phase 2a in Subjects with Obese Type 2 Diabetes Mellitus on Metformin Monotherapy

Completion Date or Terminated date	Aug. 05, 2020
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	No
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	SCOHIA PHARMA, Inc.
	Address	26-1, Muraoka Higashi 2-chome Fujisawa, Kanagawa Japan
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	SCOHIA PHARMA, Inc.
	Address	26-1, Muraoka Higashi 2-chome Fujisawa, Kanagawa Japan
	Phone Number
	E-mail Address

Recruitment Status	completed

Date of First Enrolment		Nov. 28, 2019
Target Sample Size		100
Study Type		Interventional
Study Design	Study Design	A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Comparison
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	-The subject signs and dates a written, informed consent form prior to the initiation of any study procedures. -The subject is capable of understanding and complying with protocol requirements. -The subject is either male or female and aged 18 to 65 years (inclusive) at signing of informed consent. -The subject has been treated with stable doses of metformin monotherapy (>=1000 mg/day) for at least 3 months prior to Visit 1 as determined by subject report. -The subject has a HbA1c >=7.0% (>=53 mmol/mol) and <10.5% (<=91 mmol/mol) as assessed by the central laboratory at Visit 1 and Visit 2. -The subject has a body mass index >=30kg/m2 as assessed by the study site at Visit 1 and Visit 2.
	Exclusion Criteria	1.The subject has a history of type 1 diabetes mellitus or a history of ketoacidosis; 2.The subject has a history of other specific types of diabetes (eg, genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant);
	Minimum Age	18age old over
	Maximum Age	65age old under
	Gender	Both
Health Condition or Problem Studied		Obese Type 2 Diabetes Mellitus on Metformin Monotherapy
Intervention(s)		investigational material(s) Generic name etc : SCO-792 INN of investigational material : - Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Subjects will be required to take the investigational product before meals. SCO-792 500 mg orally 3 times daily, SCO-792 500 mg orally once a day, SCO-792 250 mg orally once a day. control material(s) Generic name etc : SCO-792 Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Subjects will be required to take the investigational product before meals..SCO-792 Placebo orally 3 times daily.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety exploratory -Incidence and severity of adverse events (AE) -Incidence of serious adverse events -Clinically significant changes from baseline in -clinical laboratory tests -12-lead electrocardiograms -vital signs -physical examinations -Incidence and severity of hypoglycemia and hyperglycemia efficacy exploratory -Change in HbA1c value from baseline at the completion of the treatment period (Week 12).
Secondary Outcome		efficacy exploratory -Change in fasting plasma glucose value from baseline at the completion of the treatment period (Week 12). efficacy exploratory -Percent change in body weight value from baseline at the completion of the treatment period (Week 12).

Primary Sponsor	SCOHIA PHARMA, Inc.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name	Bellberry Human Research Ethics Committee
Address	123 Glen Osmond Road, Eastwood, SA 5063, Australia
Phone Number	+61 8 8361 3222
E-mail Address	bellberry@bellberry.com.au
Status of Review	Approval
Date of Approval	Sept. 09, 2019

Secondary ID No.	JapicCTI-194848
Name of Other Registries

Countries / Regions of Recruitment	Oceania

History of Changes

No	Publication date
5	Dec. 08, 2022	(this page)	Changes
4	Dec. 06, 2021	Detail	Changes
3	May. 27, 2021	Detail	Changes
2	Dec. 03, 2019	Detail	Changes
1	July. 18, 2019	Detail

List of change history