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

CompletedPhase 3

Sponsor: Eli Lilly and Company

Conditions: Obesity

Interventions: Orforglipron, Placebo

Countries: Japan

The main purpose of this study is to investigate the efficacy and safety of oral orforglipron in participants with obesity disease with obesity-related health problems.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Locations (16)

Naka, Ibaraki, Japan
Tsuchiura, Ibaraki, Japan
Tsuchiura, Ibaraki, Japan
Kamakura, Kanagawa, Japan
Kamakura-shi, Kanagawa, Japan
Sagamihara, Kanagawa, Japan
Kashihara, Osaka, Japan
Suita-shi, Osaka, Japan
Kawaguchi, Saitama, Japan
Chiyoda City, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Hiroshima, Japan
Osaka, Japan