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

Korábbi kezelés

• 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 a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
• Have the following cardiovascular conditions within 90 days prior to screening.

Más betegség

• Have chronic kidney disease.
• Have acute or chronic hepatitis.

Laborértékek

• 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.
• For participants without Type 2 diabetes (T2D): Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %.

Egyéb

• Have a known clinically significant gastric emptying abnormality.
• Have lupus or rheumatoid arthritis.

• 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.