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

Lilly

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Drug: Orforglipron; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05931380

J2A-JE-GZPD (Other Identifier)

18744

Details and patient eligibility

About

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.

Enrollment: 238 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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238 participants in 4 patient groups, including a placebo group

Placebo QD

Placebo Comparator group

Description:

Participants received matching placebo capsule orally once daily (QD). Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose interruption or modification was required. Treatment was administered as an adjunct to a reduced-calorie diet and increased physical activity.

Treatment:

Drug: Placebo

6 mg Orforglipron QD

Experimental group

Description:

Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose interruption or modification was required. Treatment was administered as an adjunct to a reduced-calorie diet and increased physical activity.

Treatment:

Drug: Orforglipron

12 mg Orforglipron QD

Experimental group

Description:

Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose interruption or modification was required. Treatment was administered as an adjunct to a reduced-calorie diet and increased physical activity.

Treatment:

Drug: Orforglipron

36 mg Orforglipron QD

Experimental group

Description:

Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose interruption or modification was required. Treatment was administered as an adjunct to a reduced-calorie diet and increased physical activity.

Treatment:

Drug: Orforglipron