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

NCT05931380 | Completed Phase 3 FDA Drug

• 2 other identifiers: 18744J2A-JE-GZPD
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Obesity

Keywords

Overweight; Metabolism and Nutrition Disorder

Outcome Measures

Primary Outcomes (2)

• Mean Percent Change in Body Weight

  Baseline, Week 72

• Percentage of Participants Who Achieve ≥5% Body Weight Reduction

  Baseline to Week 72

Secondary Outcomes (20)

• Percentage of Participants Who Achieve ≥10% Body Weight Reduction

  Baseline to Week 72

• Percentage of Participants Who Achieve ≥15% Body Weight Reduction

  Baseline to Week 72

• Percentage of Participants Who Achieve ≥20% Body Weight Reduction

  Baseline to Week 72

• Mean Change from Baseline in Body Mass Index (BMI)

  Baseline, Week 72

• Percentage of Participants Who Had Improvements in Hypertension

  Baseline to Week 72

Study Arms (4)

Orforglipron Dose 1

EXPERIMENTAL

Participants will receive orforglipron orally.

Drug: Orforglipron

Orforglipron Dose 2

EXPERIMENTAL

Participants will receive orforglipron orally.

Drug: Orforglipron

Orforglipron Dose 3

EXPERIMENTAL

Participants will receive orforglipron orally.

Drug: Orforglipron

Placebo

PLACEBO COMPARATOR

Participants will receive placebo.

Drug: Placebo

Interventions

Orforglipron DRUG

Administered orally

Orforglipron Dose 1; Orforglipron Dose 2; Orforglipron Dose 3

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (16)

Nishiyamadou Keiwa Hospital

Naka, Ibaraki, 311-0133, Japan

Location

Tsuchiura Beryl Clinic

Tsuchiura, Ibaraki, 300-0062, Japan

Location

Ohishi Internal Medicine Clinic

Tsuchiura, Ibaraki, 300-0835, Japan

Location

Shonan Takai Clinic

Kamakura, Kanagawa, 247-0055, Japan

Location

Takai Internal Medicine Clinic

Kamakura-shi, Kanagawa, 247-0056, Japan

Location

Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic

Sagamihara, Kanagawa, 252-0302, Japan

Location

Shiraiwa Medical Clinic

Kashihara, Osaka, 582-0005, Japan

Location

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, 565-0853, Japan

Location

Sugiura Clinic

Kawaguchi, Saitama, 332-0012, Japan

Location

Yotsuya Medical Cube

Chiyoda City, Tokyo, 102-0084, Japan

Location

Nihonbashi Sakura Clinic

Chuo-ku, Tokyo, 103-0025, Japan

Location

Tokyo-Eki Center-building Clinic

Chuo-ku, Tokyo, 103-0027, Japan

Location

Fukuwa Clinic

Chuo-ku, Tokyo, 104-0031, Japan

Location

Heishinkai Medical Group ToCROM Clinic

Shinjuku-ku, Tokyo, 160-0008, Japan

Location

Hiroshima Station Clinic

Hiroshima, 732-0053, Japan

Location

Osaka Nishiumeda Clinic

Osaka, 530-0001, Japan

Location

MeSH Terms

Conditions

Obesity; Overweight; Nutrition Disorders

Interventions

orforglipron

Condition Hierarchy (Ancestors)

Overnutrition; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 5, 2023
• Study Start: July 31, 2023
• Primary Completion: June 19, 2025
• Study Completion: June 19, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

JP (16)