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

NCT05931380 | Completed Phase 3 Results 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)

• Percent Change From Baseline in Body Weight at Week 72

  Values reported as "LS Mean" are model-based estimates (MBE) of the adjusted (unconditional) treatment effect. MBEs was calculated using an analysis of covariance (ANCOVA) model with the following variables: treatment group, baseline value, baseline Body Mass Index (BMI) category (\<35 kilogram per meter square \[kg/m²\] or ≥35 kg/m²), and stratification factors (sex and baseline type 2 diabetes status). Strata were defined by joint levels of sex (female, male) and baseline type 2 diabetes status (yes, no).

  Baseline, Week 72

• Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline

  Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression with the following variables: treatment group, baseline value, baseline BMI category (\<35 kg/m² or ≥35 kg/m²), and stratification factors (sex and baseline type 2 diabetes status). Stratification factors were defined by the combination of sex (female, male) and baseline type 2 diabetes status (yes, no). The model also allowed the treatment effect to vary across baseline values and stratification factors.

  Baseline to Week 72

Secondary Outcomes (20)

• Percentage of Participants Who Achieved ≥10% Body Weight Reduction From Baseline

  Baseline to Week 72

• Percentage of Participants Who Achieved ≥15% Body Weight Reduction From Baseline

  Baseline to Week 72

• Percentage of Participants Who Achieved ≥20% Body Weight Reduction From Baseline

  Baseline to Week 72

• Change From Baseline in Body Mass Index (BMI) at Week 72

  Baseline, Week 72

• Percentage of Participants Who Had Improvements in Hypertension

  Baseline to Week 72

Study Arms (4)

Placebo QD

PLACEBO COMPARATOR

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.

Drug: Placebo

6 mg Orforglipron QD

EXPERIMENTAL

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.

Drug: Orforglipron

12 mg Orforglipron QD

EXPERIMENTAL

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.

Drug: Orforglipron

36 mg Orforglipron QD

EXPERIMENTAL

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.

Drug: Orforglipron

Interventions

Orforglipron DRUG

Administered orally

12 mg Orforglipron QD; 36 mg Orforglipron QD; 6 mg Orforglipron QD

Placebo DRUG

Administered orally

Placebo QD

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

8005455979

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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

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: July 20, 2026
• Results First Posted: July 20, 2026

Record last verified: 2026-06

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)