臨床研究等提出・公開システム

Japanese

Date of registration	May. 29, 2025
Last modified on	May. 29, 2025
Trial ID	jRCT2051250032

Scientific Title	A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Participants With Obesity or Overweight With and Without Type 2 Diabetes J2A-MC-GZP1:Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity (excluding type 2 diabetes) (J2A-MC-GZP1)
Public Title	A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity (J2A-MC-GZP1)

Contact for Scientific Queries	Name	Masaki Takeshi
	Affiliation	Eli Lilly Japan K.K.
	Address	5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo
	Telephone	+81-120-023-812
	E-mail	LTG_CallCenter@lists.lilly.com
Contact for Public Queries	Name	Trial Guide Call Center
	Affiliation	Eli Lilly Japan K.K.
	Address	5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo
	Telephone	+81-120-023-812
	E-mail	LTG_CallCenter@lists.lilly.com

Recruitment status	Pending

Anticipated date of first enrollment		May. 29, 2025
Actual date of first enrollment
Target sample size		600
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	- Have body mass index (BMI) >=30 kilograms per square meter (kg/m2) or BMI >=25.0 kg/m2 and at least 1 of the following weight-related comorbidities at screening: * hypertension * dyslipidemia * obstructive sleep apnea, or * cardiovascular disease - Have a history of at least one unsuccessful dietary effort to lose body weight
	Exclusion Criteria	- Have type 1 diabetes, type 2 diabetes, or any other types of diabetes - Have an unstable body weight within 90 days prior to screening - Have New York Heart Association functional classification IV congestive heart failure or an acute cardiovascular condition within 90 days prior to screening - Have acute or chronic hepatitis or pancreatitis - Are taking other medications or alternative remedies to manage weight loss
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Obesity Overweight
Intervention(s)		DRUG: Orforglipron(Other Name: LY3502970) Administered orally DRUG: Placebo Administered orally (Study Arms) Experimental: Orforglipron Dose 1 Participants will receive orforglipron orally Interventions: Drug: Orforglipron Experimental: Orforglipron Dose 2 Participants will receive orforglipron orally Interventions: Drug: Orforglipron Experimental: Orforglipron Dose 3 Participants will receive orforglipron orally Interventions: Drug: Orforglipron Experimental: Orforglipron Dose 4 Participants will receive orforglipron orally Interventions: Drug: Orforglipron Placebo Comparator: Placebo Participants will receive placebo orally Interventions: Drug: Placebo
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 40
Secondary Outcome(s)

Primary Sponsor	Eli Lilly Japan K.K.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	-
Address	-, Hyogo
Telephone
E-Mail
Approval Status	Not approval
Date of approval

Plan to share IPD	Yes
Plan description	Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Secondary ID(s)	NCT06972459
Issuing Authority	ClinicalTrial.gov

Countries of Recruitment（Except Japan）	United States/Argentina/China/Czechia/Germany/India/Mexico/Puerto Rico