Phase 3 · Orforglipron

ATTAIN-2 trial results

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)

Percent Change From Baseline in Body Weight (percent change), Baseline, Week 72. Placebo: -2.21; 6 mg Orforglipron QD: -5.50; 12 mg Orforglipron QD: -7.78; 36 mg Orforglipron QD: -10.54.

Participants
1,613
Status
completed
Completed
2025-08-08
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT05872620), updated at source Sep 4, 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-2 measured first

Percent Change From Baseline in Body Weightpercent change · Baseline, Week 72 · least squares mean
Placebon=6306 mg Orforglipron QDn=32912 mg Orforglipron QDn=33236 mg Orforglipron QDn=322
-2.21(0.215)-5.50(0.356)-7.78(0.411)-10.54(0.466)
Side effects by arm

Side effects in ATTAIN-2

Percent of participants affected, Baseline Up to Week 74. The most common events the registry lists.

EventPlacebo6 mg Orforglipron QD12 mg Orforglipron QD36 mg Orforglipron QD
Any serious event8.8%7.3%10.3%10.9%
Hyperglycaemia39.3%13.1%9.7%8.4%
Nausea8.4%20.1%31.1%36.4%
Diarrhoea15%21.3%24.8%27.4%
Vomiting3.8%12.8%20.2%23.1%
Constipation7.8%17.7%21.1%22.4%
Dyspepsia3.5%9.1%15.4%10.9%
Decreased appetite2.9%8.2%9.1%15.3%
Eructation0.6%6.4%11.5%8.7%
Upper respiratory tract infection8.8%7.6%9.7%10.3%
Nasopharyngitis9.4%9.1%6.6%7.2%
Abdominal distension3.5%7%6.9%8.4%
Flatulence2.7%7.3%6.9%7.2%
Gastrooesophageal reflux disease2.9%5.8%6.9%6.9%
Dizziness2.9%5.8%3.3%6.9%
Headache5.3%5.2%5.7%6.9%
Back pain4.3%5.5%3.9%6.5%
Covid-196.4%3.4%5.4%5.6%
Abdominal pain upper2.7%5.5%6.3%3.7%
Hypertension6.2%4.3%5.7%5%
Abdominal pain2.5%5.8%6%5.3%
Fatigue2.9%3%6%5.3%
Lipase increased3.3%2.4%3.6%5.6%
Diabetic retinopathy5.4%4.6%4.2%5.3%
Urinary tract infection3.8%4%5.4%5%
Arthralgia5.1%5.2%4.2%4.7%
Secondary outcomes

What else it measured

Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From BaselinePercentage of participants · Baseline to Week 72 · number
Placebon=6306 mg Orforglipron QDn=32912 mg Orforglipron QDn=33236 mg Orforglipron QDn=322
24.449.860.272.8
Percentage of Participants Who Achieved ≥10% Body Weight Reduction From BaselinePercentage of participants · Baseline to Week 72 · number
Placebon=6306 mg Orforglipron QDn=32912 mg Orforglipron QDn=33236 mg Orforglipron QDn=322
7.023.935.550.1
Percentage of Participants Who Achieved ≥15% Body Weight Reduction From BaselinePercentage of participants · Baseline to Week 72 · number
Placebon=6306 mg Orforglipron QDn=32912 mg Orforglipron QDn=33236 mg Orforglipron QDn=322
1.97.317.728.4
Change From Baseline in Waist Circumferencecentimeters · Baseline, Week 72 · least squares mean
Placebon=6306 mg Orforglipron QDn=32912 mg Orforglipron QDn=33236 mg Orforglipron QDn=322
-2.67(0.233)-5.64(0.394)-7.16(0.422)-9.16(0.437)
Change From Baseline in Hemoglobin A1c (HbA1c) %percentage of HbA1c · Baseline, Week 72 · least squares mean
Placebon=6306 mg Orforglipron QDn=32912 mg Orforglipron QDn=33236 mg Orforglipron QDn=322
-0.14(0.060)-1.29(0.069)-1.60(0.058)-1.79(0.059)
Change From Baseline in Fasting Serum Glucose (FSG)milligram per deciliter (mg/dL) · Baseline, Week 72 · least squares mean
Placebon=6306 mg Orforglipron QDn=32912 mg Orforglipron QDn=33236 mg Orforglipron QDn=322
1.2(1.90)-33.0(2.13)-41.1(1.69)-45.8(1.79)
Percentage of Participants Who Achieved Hemoglobin A1c (HbA1c) Target Value (<6.5%)Percentage of participants · Baseline to Week 72 · number
Placebon=6306 mg Orforglipron QDn=32912 mg Orforglipron QDn=33236 mg Orforglipron QDn=322
10.656.267.575.0
Percentage of Participants Who Achieved Hemoglobin A1c (HbA1c) Target Value (<7.0%)Percentage of participants · Baseline to Week 72 · number
Placebon=6306 mg Orforglipron QDn=32912 mg Orforglipron QDn=33236 mg Orforglipron QDn=322
23.070.078.085.1
Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)millimeters of mercury (mmHg) · Baseline, Week 72 · least squares mean
Placebon=630Pooled 6 mg/12 mg/36 mg Orforglipron QDn=983
-1.48(0.534)-4.90(0.414)
Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)millimeters of mercury (mmHg) · Baseline, Week 72 · least squares mean
Placebon=630Pooled 6 mg/12 mg/36 mg Orforglipron QDn=983
-1.39(0.323)-1.32(0.261)
Percent Change From Baseline in Fasting Insulinpercent change · Baseline, Week 72 · geometric least squares mean
Placebon=6096 mg Orforglipron QDn=32112 mg Orforglipron QDn=32136 mg Orforglipron QDn=313
-8.8(2.54)-6.4(2.89)-8.3(3.18)-18.0(2.91)
Percent Change From Baseline in Non-High-Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)percent change · Baseline, Week 72 · geometric least squares mean
Placebon=607Pooled 6 mg/12 mg/36 mg Orforglipron QDn=952
-2.95(1.182)-6.41(0.880)
The trial

How ATTAIN-2 was run

This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.

  • Placebo: Participants received matching placebo capsule orally once daily (QD). Treatment was initiated with placebo corresponding to 1 milligram (mg) equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
  • 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 modification was required.
  • 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 modification was required.
  • 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 modification was required.
Who could join the trial

Inclusion Criteria: * Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²). * Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight. * Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of: * either diet/exercise alone or * up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA). Exclusion Criteria: * Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D. * Have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening. * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors). * Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome. * Have had a history of chronic or acute pancreatitis.

Published papers

Papers from ATTAIN-2

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

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