ATTAIN-J

CompletedPhase 3

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

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

Lead sponsor

Eli Lilly and Company

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

238

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05931380

Org study ID18744

Secondary IDJ2A-JE-GZPDEli Lilly and Company

Timeline

Milestones

Study first posted2023-07-05actual

Study start2023-07-31actual

Primary completion2025-06-19actual

Study completion2025-06-19actual

Last update posted2025-08-12actual

Assets

Investigational agents

Orforglipron

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (22)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Cardiometabolic biomarkers

Glycemic / diabetes

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

8 endpoints

Primary/protocol endpoint

Mean Percent Change in Body Weight

Time frame:Baseline, Week 72

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Percentage of Participants Who Achieve ≥5% Body Weight Reduction

Time frame:Baseline to Week 72

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥10% Body Weight Reduction

Time frame:Baseline to Week 72

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

Time frame:Baseline to Week 72

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥20% Body Weight Reduction

Time frame:Baseline to Week 72

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Mean Change from Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 72

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change from Baseline in Visceral Adipose Tissue (VAT)

Time frame:Baseline, Week 72

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change from Baseline in Waist Circumference at Umbilical Level

Time frame:Baseline, Week 72

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Secondary/protocol endpoint

Percentage of Participants Who Achieve HbA1c Target value (<6.5% (48 mmol/mol) at Week 72 (only T2D at Baseline):

Time frame:Baseline to Week 72

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Mean Change from Baseline in Fasting Glucose

Time frame:Baseline, Week 72

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Mean Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 72

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time to Onset of Type 2 Diabetes (T2D) (only non T2D at Baseline)

Time frame:Baseline to Week 72

Time to T2DM onset

time to event, event

Cardiometabolic biomarkers

7 endpoints

Secondary/protocol endpoint

Percentage of Participants Who Had Improvements in Hypertension

Time frame:Baseline to Week 72

categorical status, improvement

Secondary/protocol endpoint

Percentage of Participants Who Had Improvements in Dyslipidemia (only for participants with Dyslipidemia at baseline)

Time frame:Baseline to Week 72

categorical status, improvement

Secondary/protocol endpoint

Mean Change from Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, Week 72

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Mean Change from Baseline in non-High Density Lipoprotein (HDL)

Time frame:Baseline, Week 72

Non-HDL cholesterol, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change from Baseline in HDL

Time frame:Baseline, Week 72

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Mean Change from Baseline in Triglycerides

Time frame:Baseline, Week 72

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Mean Change from Baseline in High-sensitivity C-reactive Protein

Time frame:Baseline, Week 72

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Mean Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 72

IWQOL-Lite total

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Pharmacokinetics (PK): Plasma Concentration of Orforglipron

Time frame:Baseline to Week 72

Plasma concentration (steady state)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.