臨床研究等提出・公開システム

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Japanese Adult Participants With Obesity Disease (J2A-JE-GZPD )

A Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity Disease (J2A-JE-GZPD)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Not Recruiting

July. 31, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Participants with a BMI >=27 kg/m2 and <35 kg/m2 and at least 2 obesity-related health problems (treated or untreated), OR a BMI >=35 kg/m2 and at least 1 obesity-related health problem (treated or untreated). At least one obesity-related health problem should be hypertension, dyslipidemia or T2D (approximately 25% of participants).
Have a history of at least one self-reported unsuccessful dietary effort to lose body weight.
Males and females may participate in this trial. Female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed.
Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
No male contraception is required except in compliance with specific local government study requirements.

For participants with Type 2 Diabetes (T2D):

Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within the 180 days prior to screening.
Have renal impairment measured as estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2, calculated by Japanese Society of Nephrology coefficient-modified chronic kidney disease-epidemiology equation during screening.
Have a known clinically significant gastric emptying abnormality.
For participants without Type 2 diabetes (T2D): Have any type of diabetes with hemoglobin A1c (HbA1c) >=6.5 %.
Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
Have chronic kidney disease.
Have lupus or rheumatoid arthritis.
Have the following cardiovascular conditions within 90 days prior to screening.
Have acute or chronic hepatitis.

Both

Obesity

Drug: Orforglipron
Administered orally
Drug: Placebo
Administered orally

Study Arms
Experimental: Orforglipron Dose 1
Participants will receive orforglipron orally.
Intervention: Drug: Orforglipron
Experimental: Orforglipron Dose 2
Participants will receive orforglipron orally.
Intervention: Drug: Orforglipron
Experimental: Orforglipron Dose 3
Participants will receive orforglipron orally.
Intervention: Drug: Orforglipron
Placebo Comparator: Placebo
Participants will receive placebo.
Intervention: Drug: Placebo

Mean Percent Change in Body Weight [ Time Frame: Baseline, Week 72 ]
Percentage of Participants Who Achieve >=5% Body Weight Reduction [ Time Frame: Baseline to Week 72 ]

+81-48-222-5015

June. 08, 2023

Yes

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.

none