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| **1716-P\ |
| Menopausal Stage and Weight Outcomes with Orforglipron vs Placebo Post-Hoc Subgroup Analysis from ATTAIN-1 and ATTAIN-2** |
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| Authors: Andreea Ciudin1, Beverly G. Tchang2, Amelia J. Balmain3, Suzanne Klise3Donna Mojdami3, Wenyu Ye3, Xiaojuan Mi4, Hunter T. Hoffmann3 |
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| \ |
| 1.Hospital Universitari Vall d'Hebron, Barcelona, Spain\ |
| 2.Comprehensive Weight Control Center, Weill Cornell Medicine, New York, NY, USA\ |
| 3.Eli Lilly and Company, Indianapolis, IN, USA\ |
| 4.TechData Services Company, King of Prussia, PA, USA |
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| # Sponsored by Eli Lilly and Company |
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| Objective |
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| - This post-hoc analysis of ATTAIN-1 and ATTAIN-2 evaluated the relationship of orforglipron treatment and body |
| weight in females, stratified by menopausal stage. |
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| Conclusions |
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| - At Week 72, regardless of menopausal stage, participants on orforglipron 36 mg had\ |
| significantly greater reductions in percent body weight (BW) and waist circumference versus\ |
| placebo. |
| - Compared to placebo, significantly more participants on orforglipron 36 mg achieved a\ |
| majority of BW reduction threshold targets. |
| - When comparing waist-to-height ratio (WHtR), a greater percentage of females on orforglipron\ |
| 36 mg achieved a lower WHtR at Week 72 compared to placebo. |
| - Orforglipron supports weight reduction in females across the spectrum of menopausal stages,\ |
| demonstrated in both ATTAIN-1 and ATTAIN-2. |
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| Background |
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| - Estrogen deficiency in menopause can increase the risk of obesity and cardiometabolic outcomes.1,2,3 |
| - Orforglipron (OFG) is a small molecule, novel, non-peptide glucagon-like peptide-1 (GLP-1) receptor agonist |
| administered once daily orally. |
| - OFG is FDA-approved to reduce excess body weight and maintain weight reduction long-term in adults with obesity or |
| overweight with ≥1 obesity-related complication in combination with a reduced-calorie diet and increased physical |
| activity, and is being investigated for use in type 2 diabetes.4 |
| - Both ATTAIN-1 and ATTAIN-2 demonstrated significant reductions in body weight (BW) in adults with obesity and with |
| or without type 2 diabetes, compared to placebo (PBO).5,6 |
| - Due to the impact of menopause on obesity and cardiometabolic risk, the impact of OFG on BW outcomes is of interest |
| in this population. |
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| **Study design and participants** |
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| ATTAIN-1 (Phase 3, Multinational, Randomized Double-Blind Trial)5 |
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| OFG 6, 12, 36 mg QD (N=2178) Vs PBO QD (N=949) |
| |
| - Duration: 72 weeks |
| - Adults with obesity (defined as BMI ≥30 kg/m2) or overweight (BMI 27 to 30 kg/m2) with ≥1 obesity-related complication |
| - Key exclusion: Diabetes (type 1 or type 2) |
| - Adjunct to a healthy diet and physical activity |
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| ATTAIN-1 (Phase 3, Multinational, Randomized Double-Blind Trial)6 |
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| OFG 6, 12, 36 mg QD (N=983) vs PBO QD (N=630) |
| |
| - Duration: 72 weeks |
| - Adults with BMI ≥27 kg/m2 and pre-existing type 2 diabetes |
| - Key exclusion: Any other type of diabetes except type 2 diabetes |
| - Adjunct to a healthy diet and physical activity |
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| N: number of participants in the population in the specified treatment group. OFG capsule formulations of 6 mg, 12 |
| mg, and 36 mg doses have been shown as the equivalent tablet doses of 5.5 mg, 9 mg, and 17.2 mg, which are approved |
| in the United States.7 Abbreviations: BMI: body mass index; QD: once daily |
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| Methods |
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| - Post-hoc analysis: included females with menopausal status (pre, peri, post): N=2003 from ATTAIN-1 and N=754 from |
| ATTAIN-2. |
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| - All treatment arms included in analyses, but reported OFG 36 mg and PBO in this document. |
| |
| - Presents data from the investigational OFG capsule formulation of 36 mg. The dose has been shown as the equivalent |
| tablet dose of 17.2 mg, which is approved in the United States. 7 |
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| - Outcomes (analyses guided by efficacy estimand): |
| |
| - Change from baseline to Week 72 in percent BW reduction and waist circumference. |
| - Proportion of participants achieving BW reduction threshold targets at Week 72 (≥5%, ≥10%, ≥15%, ≥20%). |
| - Proportion of participants in each waist-to-height ratio (WHtR) category at baseline and Week 72 by treatment group. |
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| Menopausal Staging |
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| - **Pre-menopausal**: Aged <45 years without any indication of menopause. |
| - **Peri-menopausal**: Aged ≤54 years with diagnosis of menopausal symptoms or evidence for clinical suspicion for |
| menopause but not satisfying criteria for post-menopause; or aged 45–54 with no evidence for menopause. |
| - **Post-menopausal**: Aged ≥40 years with documented medical history indicating menopause, or follicle stimulating |
| hormone (FSH) ≥40 mIU/mL without hormone replacement therapy, or being aged ≥55 years. |
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| # Baseline Demographics and Clinical Characteristics |
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| Data are mean ± SD or n (%) at baseline. N: number of participants, n: number of participants in specified group. |
| Note: Presents data from the investigational OFG capsule formulation of 36 mg. Dose has been shown as the equivalent |
| tablet dose of 17.2 mg, which is approved in the United States.7 Abbreviations: BMI: body mass index; BW: |
| body weight; HbA1c: glycated hemoglobin; OFG: orforglipron; ORCs: obesity-related complications; PBO: placebo; PCOS: |
| polycystic ovary syndrome; SD: standard deviation; WHtR: waist-to-height ratio. |
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| Key Results |
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| **Panel A**: Data are MBE (SE) percent change from baseline in BW and change from baseline in waist circumference at |
| the primary endpoint (Week 72). Analyzed using MMRM adjusted for stratification factors and baseline value. |
| |
| **Panel B**: Data are MBE proportion of achieving body weight reduction targets (%) (SE) at Week 72. MBE for endpoint |
| measures are from logistic regression model using imputed data, adjusted for stratification factors and baseline |
| values. |
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| **Note**: Presents data from the investigational OFG capsule formulation of 36 mg. The dose has been shown as the |
| equivalent tablet dose of 17.2 mg, which is approved in the United States.⁷ |
| |
| **Abbreviations**: BW: body weight; MBE: model-based estimate; MMRM: mixed model for repeated measure; OFG: |
| orforglipron; PBO: placebo; Peri: peri-menopausal; Pre: pre-menopausal; Post: post-menopausal; SE: standard error. |
| \*p<0.05 and \*\*p<0.001 OFG 36 mg vs PBO. |
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| # Additional Results |
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| Proportion of participants in each WHtR category at baseline to Week 72, by menopausal stage and treatment group. |
| Includes only participants with a baseline value and ≥1 post-baseline WHtR measurement. N= total participants per |
| treatment group within menopausal stage; n= participants in each WHtR category; Abbreviations: OFG: orforglipron; |
| PBO: placebo; Peri: peri-menopausal; Pre: pre-menopausal; Post: post-menopausal; WHtR: waist-to-height ratio; Wk 72: |
| Week 72; Presents data from the investigational OFG capsule formulation of 36 mg. The dose has been shown as the |
| equivalent tablet dose of 17.2 mg, which is approved in the United States.⁷ |
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| **References** |
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| - Carr MC. J Clin Endocrinol Metab. 2003;88(6):2404-2411. |
| - Ko SH, Jung Y. Nutrients. 2021;13(12):4556. |
| - Kirtikar U, Kajale N, Patwardhan V, Khadilkar V, Khadilkar AV. J Midlife Health. 2020;11(1):22-26. |
| - Eli Lilly and Company. Foundayo® (orforglipron) prescribing information. 2026. Available at: |
| https\://pi.lilly.com/us/foundayo-uspi.pdf. |
| - Wharton S, Aronne LJ, Stefanski A, et al. N Engl J Med. 2025;393(18):1796-1806. |
| - Horn DB, Ryan DH, Kis SG, et al. Lancet. 2026;406(10522):2927-2944. |
| - Ma X, Li YG, Raha S, Sperry DC, Coutant DE, Bhattachar S. Diabetes Obes Metab. 2026. |
| |
| **Acknowledgments:** The authors would like to thank Lindsey Anderson, PharmD (Eli Lilly and Company) for their |
| writing and editorial contributions. |
| |
| **Disclosures:** AC reports receiving speaking fees from Astra Zeneca, Boehringer-Ingelheim, Eli-Lilly, Novo Nordisk, |
| Sanofi, Menarini and research grants from Eli Lilly, NovoNordisk and Menarini. AC reports as a member of the DMC of |
| Boehringer Ingelheim. BGT reports current or past consulting/advisor fees from Novo Nordisk, Roman Health Ventures, |
| Skye Bioscience, Circadian Care, Amgen, Lilly, Boehringer-Ingelheim, Gelesis, Cloud Health Systems, SAI MedPartners, |
| Tern Pharmaceuticals, and Intellihealth/Flyte Health. XM is an employee of TechData Services, which is in contract |
| with Eli Lilly and Company. AB, SK, DM, WY, and HH are employees and stockholders of Eli Lilly and Company. |
| |
| Copyright ©2026 Eli Lilly and Company. All rights reserved. |
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| Metadata |
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| title | Menopausal Stage and Weight Outcomes with Orforglipron vs Placebo: Post-Hoc Subgroup Analysis from ATTAIN-1 and ATTAIN-2 |
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| published-time | 2026-06-16T17:30:49.348Z |
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| | post-menopausal). Phase 3 randomized controlled trial. Outcomes: Percent body weight change from baseline at Week 72; Waist circumference change from |
| | baseline at Week 72; Proportion achieving ≥5%, ≥10%, ≥15%, ≥20% body weight reduction at Week 72; Waist-to-height ratio (WHtR) category distribution at |
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| | vs Placebo: Post-Hoc Subgroup Analysis from ATTAIN-1 and ATTAIN-2", "alternativeHeadline": "Poster 1716-P — ADA 2026", "description": "At |
| | Week 72, regardless of menopausal stage, participants on orforglipron 36 mg had significantly greater reductions in percent body weight and waist |
| | circumference versus placebo. Orforglipron supports weight reduction in females across the spectrum of menopausal stages.", "url": |
| | "https\://www\.lilly.com/hcp/congresses/ada-2026/ofg-post-menopausal", "keywords": \[ "orforglipron", "GLP-1 receptor agonist", |
| | "menopause", "obesity", "weight loss", "body weight", "waist circumference", "WHtR", "ATTAIN-1", |
| | "ATTAIN-2", "post-menopausal", "peri-menopausal", "pre-menopausal", "ADA 2026", "Foundayo" ], |
| | "about": \[ { "@type": "MedicalCondition", "name": "Obesity" }, { "@type": "MedicalCondition", |
| | "name": "Overweight" }, { "@type": "MedicalCondition", "name": "Menopause" }, { |
| | "@type": "MedicalCondition", "name": "Type 2 Diabetes" }, { "@type": "MedicalCondition", "name": |
| | "Obesity-related cardiometabolic risk" }, { "@type": "MedicalCondition", "name": "Menopausal weight gain" } |
| | ], "author": \[ { "@type": "Person", "name": "Andreea Ciudin", "affiliation": { "@type": |
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| | "name": "Eli Lilly and Company" } }, { "@type": "Person", "name": "Donna Mojdami", |
| | "affiliation": { "@type": "Organization", "name": "Eli Lilly and Company" } }, { "@type": |
| | "Person", "name": "Wenyu Ye", "affiliation": { "@type": "Organization", "name": "Eli Lilly and Company" |
| | } }, { "@type": "Person", "name": "Xiaojuan Mi", "affiliation": { "@type": |
| | "Organization", "name": "TechData Services Company" } }, { "@type": "Person", "name": "Hunter |
| | T. Hoffmann", "affiliation": { "@type": "Organization", "name": "Eli Lilly and Company" } } ], |
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| | "name": "Does orforglipron reduce body weight in post-menopausal females?", "acceptedAnswer": { "@type": "Answer", |
| | "text": "Yes. In both ATTAIN-1 and ATTAIN-2, post-menopausal females treated with orforglipron 36 mg achieved significantly greater reductions in |
| | percent body weight versus placebo at Week 72 (ATTAIN-1: −14.07% vs −0.62%; ATTAIN-2: −13.62% vs −2.00%, both p<0.001)." } }, |
| | { "@type": "Question", "name": "How does menopausal stage affect weight loss with orforglipron?", "acceptedAnswer": { |
| | "@type": "Answer", "text": "Orforglipron 36 mg produced significant body weight reductions across all menopausal stages (pre, peri, |
| | and post-menopausal) compared to placebo in both ATTAIN-1 and ATTAIN-2 at Week 72, demonstrating consistent efficacy regardless of menopausal stage." |
| | } }, { "@type": "Question", "name": "What is orforglipron and how is it taken?", "acceptedAnswer": |
| | { "@type": "Answer", "text": "Orforglipron (brand name Foundayo) is a small molecule, non-peptide GLP-1 receptor agonist taken |
| | orally once daily. It is FDA-approved to reduce excess body weight and maintain weight reduction long-term in adults with obesity or overweight with at |
| | least one obesity-related complication, used alongside a reduced-calorie diet and increased physical activity." } }, { |
| | "@type": "Question", "name": "Did orforglipron reduce waist circumference in menopausal females?", "acceptedAnswer": { |
| | "@type": "Answer", "text": "Yes. At Week 72, females on orforglipron 36 mg had significantly greater reductions in waist circumference |
| | versus placebo across all menopausal stages in both ATTAIN-1 and ATTAIN-2." } }, { "@type": "Question", |
| | "name": "What proportion of post-menopausal females lost ≥10% body weight with orforglipron?", "acceptedAnswer": { "@type": |
| | "Answer", "text": "In ATTAIN-1, 64.12% of post-menopausal females on orforglipron 36 mg achieved ≥10% body weight reduction versus 8.90% on |
| | placebo (p<0.001). In ATTAIN-2, 67.95% achieved ≥10% versus 6.47% on placebo (p<0.001)." } }, { "@type": "Question", |
| | "name": "What is waist-to-height ratio (WHtR) and how did it change with orforglipron?", "acceptedAnswer": { "@type": |
| | "Answer", "text": "Waist-to-height ratio (WHtR) is a measure of central adiposity and cardiometabolic risk. At Week 72, a greater proportion |
| | of females on orforglipron 36 mg shifted to lower WHtR categories (≤0.49 or >0.49 to ≤0.59) compared to placebo, across all menopausal stages in both |
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