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

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Japanese Adult Participants With Obesity Disease

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebo; Drug: Orforglipron

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Hiroshima, Japan, 732-0053
    • Hiroshima Station Clinic
  • Osaka, Japan, 530-0001
    • Osaka Nishiumeda Clinic
  • Ibaraki
    • Naka, Ibaraki, Japan, 311-0133
      • Nishiyamadou Keiwa Hospital
    • Tsuchiura, Ibaraki, Japan, 300-0062
      • Tsuchiura Beryl Clinic
    • Tsuchiura, Ibaraki, Japan, 300-0835
      • Ohishi Internal Medicine Clinic
  • Kanagawa
    • Kamakura, Kanagawa, Japan, 247-0055
      • Shonan Takai Clinic
    • Kamakura-shi, Kanagawa, Japan, 247-0056
      • Takai Internal Medicine Clinic
    • Sagamihara, Kanagawa, Japan, 252-0302
      • Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic
  • Osaka
    • Kashiwara, Osaka, Japan, 582-0005
      • Shiraiwa Medical Clinic
    • Suita-shi, Osaka, Japan, 565-0853
      • Medical Corporation Heishinkai OCROM Clinic
  • Saitama
    • Kawaguchi, Saitama, Japan, 332-0012
      • Sugiura Clinic
  • Tokyo
    • Chiyoda, Tokyo, Japan, 102-0084
      • Yotsuya Medical Cube
    • Chuo-ku, Tokyo, Japan, 103-0025
      • Nihonbashi Sakura Clinic
    • Chuo-ku, Tokyo, Japan, 103-0027
      • Tokyo-Eki Center-building Clinic
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Fukuwa Clinic
    • Shinjuku-ku, Tokyo, Japan, 160-0008
      • Heishinkai Medical Group ToCROM Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive placebo.	Drug: Placebo; Administered orally
Experimental: Orforglipron Dose 1; Participants will receive orforglipron orally.	Drug: Orforglipron; Administered orally
Experimental: Orforglipron Dose 2; Participants will receive orforglipron orally.	Drug: Orforglipron; Administered orally
Experimental: Orforglipron Dose 3; Participants will receive orforglipron orally.	Drug: Orforglipron; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Percent Change in Body Weight	Baseline, Week 72
Percentage of Participants Who Achieve ≥5% Body Weight Reduction	Baseline to Week 72

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean Change from Baseline in Systolic Blood Pressure (SBP)	Baseline, Week 72
Mean Change from Baseline in Fasting Glucose	Baseline, Week 72
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
Percentage of Participants Who Had Improvements in Dyslipidemia (only for participants with Dyslipidemia at baseline)	Baseline to Week 72
Percentage of Participants Who Achieve HbA1c Target value (<6.5% (48 mmol/mol) at Week 72 (only T2D at Baseline):	Baseline to Week 72
Mean Change from Baseline in Visceral Adipose Tissue (VAT)	Baseline, Week 72
Mean Change from Baseline in Waist Circumference at Umbilical Level	Baseline, Week 72
Mean Change from Baseline in non-High Density Lipoprotein (HDL)	Baseline, Week 72
Mean Change from Baseline in HDL	Baseline, Week 72
Mean Change from Baseline in Triglycerides	Baseline, Week 72
Mean Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 72
Mean Change from Baseline in High-sensitivity C-reactive Protein	Baseline, Week 72
Mean Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores	Baseline, Week 72
Mean Change from Baseline in IMPACT of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function, Physical, and Psychosocial Composite Score	Baseline, Week 72
Time to Onset of Type 2 Diabetes (T2D) (only non T2D at Baseline)	Baseline to Week 72
Pharmacokinetics (PK): Plasma Concentration of Orforglipron	Baseline to Week 72

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Actual): June 19, 2025
• Study Completion (Actual): June 19, 2025

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Overweight; Metabolism and Nutrition Disorder
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: 18744; J2A-JE-GZPD (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes