Phase 3 · Orforglipron

ATTAIN-J trial results

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

Percent Change From Baseline in Body Weight at Week 72 (percent change), Baseline, Week 72. Placebo QD: -0.63; 6 mg Orforglipron QD: -5.90; 12 mg Orforglipron QD: -8.69; 36 mg Orforglipron QD: -7.93.

Participants
238
Status
completed
Completed
2025-06-19
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT05931380), updated at source Jul 20, 2026. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What ATTAIN-J measured first

Percent Change From Baseline in Body Weight at Week 72percent change · Baseline, Week 72 · least squares mean
Placebo QDn=606 mg Orforglipron QDn=6112 mg Orforglipron QDn=5736 mg Orforglipron QDn=60
-0.63(0.732)-5.90(0.866)-8.69(1.136)-7.93(1.063)
Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From BaselinePercentage of Participants · Baseline to Week 72 · number
Placebo QDn=606 mg Orforglipron QDn=6112 mg Orforglipron QDn=5736 mg Orforglipron QDn=60
15.0045.9061.4058.33
Side effects by arm

Side effects in ATTAIN-J

Percent of participants affected, Baseline up to end of follow-up (up to 74 weeks). The most common events the registry lists.

EventPlacebo QD6 mg Orforglipron QD12 mg Orforglipron QD36 mg Orforglipron QD
Any serious event8.3%1.6%5.3%10%
Nasopharyngitis35%26.2%42.1%20%
Constipation8.3%36.1%28.1%31.7%
Nausea0%13.1%15.8%33.3%
Diarrhoea3.3%14.8%7%16.7%
Vomiting0%6.6%8.8%16.7%
Covid-1916.7%6.6%14%3.3%
Dyspepsia0%3.3%8.8%13.3%
Abdominal discomfort3.3%6.6%12.3%1.7%
Influenza10%0%7%8.3%
Herpes zoster8.3%3.3%0%1.7%
Menopause0%0%0%8.3%
Bronchitis0%3.3%7%3.3%
Eructation1.7%6.6%1.8%6.7%
Cystitis6.7%4.9%1.8%3.3%
Hyperglycaemia6.7%0%0%0%
Back pain6.7%6.6%3.5%5%
Abdominal distension0%6.6%0%3.3%
Gastroenteritis3.3%6.6%5.3%0%
Pruritus0%6.6%0%0%
Contusion3.3%4.9%5.3%3.3%
Coronavirus infection5%4.9%0%1.7%
Pharyngitis5%4.9%1.8%5%
Lipase increased1.7%0%1.8%5%
Arthralgia5%1.6%3.5%5%
Myalgia0%3.3%0%5%
Secondary outcomes

What else it measured

Percentage of Participants Who Achieved ≥10% Body Weight Reduction From BaselinePercentage of Participants · Baseline to Week 72 · number
Placebo QDn=606 mg Orforglipron QDn=6112 mg Orforglipron QDn=5736 mg Orforglipron QDn=60
3.3318.0335.0938.33
Percentage of Participants Who Achieved ≥15% Body Weight Reduction From BaselinePercentage of Participants · Baseline to Week 72 · number
Placebo QDn=606 mg Orforglipron QDn=6112 mg Orforglipron QDn=5736 mg Orforglipron QDn=60
09.8422.8118.33
Percentage of Participants Who Achieved ≥20% Body Weight Reduction From BaselinePercentage of Participants · Baseline to Week 72 · number
Placebo QDn=606 mg Orforglipron QDn=6112 mg Orforglipron QDn=5736 mg Orforglipron QDn=60
03.2812.288.33
Change From Baseline in Body Mass Index (BMI) at Week 72kilograms per meter square (kg/m^2) · Baseline, Week 72 · least squares mean
Placebo QDn=606 mg Orforglipron QDn=6112 mg Orforglipron QDn=5736 mg Orforglipron QDn=60
-0.21(0.230)-1.94(0.271)-2.83(0.354)-2.63(0.355)
Percentage of Participants Who Had Improvements in HypertensionPercentage of Participants · Baseline to Week 72 · number
Placebo QDn=476 mg Orforglipron QDn=4912 mg Orforglipron QDn=5036 mg Orforglipron QDn=51
14.934.730.023.5
Percentage of Participants Who Had Improvements in DyslipidemiaPercentage of Participants · Baseline to Week 72 · number
Placebo QDn=466 mg Orforglipron QDn=4712 mg Orforglipron QDn=4436 mg Orforglipron QDn=46
60.957.463.665.2
Percentage of Participants Who Achieve Hemoglobin A1c (HbA1c) Target Value (<6.5% [48 mmol/Mol])Percentage of Participants · Baseline to Week 72 · number
Placebo QDn=146 mg Orforglipron QDn=1612 mg Orforglipron QDn=1136 mg Orforglipron QDn=14
031.2545.4578.57
Mean Change From Baseline in Visceral Adipose Tissue (VAT) at Week 72Square Centimeter (cm^2) · Baseline, Week 72 · least squares mean
Placebo QDn=306 mg Orforglipron QDn=2212 mg Orforglipron QDn=2536 mg Orforglipron QDn=25
-7.20(5.220)-47.5(5.519)-52.3(8.043)-49.3(6.526)
Mean Change From Baseline in Waist Circumference at Umbilical Level at Week 72Centimeter · Baseline, Week 72 · least squares mean
Placebo QDn=606 mg Orforglipron QDn=6112 mg Orforglipron QDn=5736 mg Orforglipron QDn=60
-0.063(0.592)-3.67(0.845)-5.87(0.851)-5.67(0.909)
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 72millimeters of mercury (mmHg) · Baseline, Week 72 · least squares mean
Placebo QDn=606 mg Orforglipron QDn=6112 mg Orforglipron QDn=5736 mg Orforglipron QDn=60
-0.055(1.415)-5.08(1.673)-3.84(1.636)-4.36(1.342)
Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) at Week 72percent change · Baseline, Week 72 · least squares mean
Placebo QDn=606 mg Orforglipron QDn=6112 mg Orforglipron QDn=5736 mg Orforglipron QDn=60
0.05(1.711)-6.91(2.270)-10.20(2.395)-10.75(2.352)
Percent Change From Baseline in High Density Lipoprotein (HDL) at Week 72percent change · Baseline, Week 72 · least squares mean
Placebo QDn=606 mg Orforglipron QDn=6112 mg Orforglipron QDn=5736 mg Orforglipron QDn=60
7.37(2.079)5.75(2.314)8.62(2.628)5.17(2.199)
The trial

How ATTAIN-J was run

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.

  • Placebo QD: 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.
  • 6 mg Orforglipron QD: 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.
  • 12 mg Orforglipron QD: 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.
  • 36 mg Orforglipron QD: 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.
Who could join the trial

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.

Published papers

Papers from ATTAIN-J

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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