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

• Status: Active, not recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

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.