Lilly's oral GLP-1, orforglipron, delivers weight loss of up to an average of 27.3 lbs in first of two pivotal Phase 3 trials in adults with obesity
Eli Lilly (NYSE:LLY) announced positive Phase 3 ATTAIN-1 trial results for orforglipron, its investigational oral GLP-1 receptor agonist, in treating obesity. The once-daily pill demonstrated significant weight loss, with participants taking the highest dose (36mg) losing an average of 27.3 lbs (12.4%) compared to 2.2 lbs (0.9%) with placebo over 72 weeks.
The trial, involving 3,127 adults, met all primary and secondary endpoints. At the highest dose, 59.6% of participants lost 鈮�10% body weight, and 39.6% lost 鈮�15%. The drug also showed improvements in cardiovascular risk markers, including a 47.7% reduction in hsCRP levels. The safety profile aligned with injectable GLP-1 therapies, with mainly gastrointestinal side effects.
Lilly plans to submit orforglipron for regulatory review by year-end and is preparing for a global launch.
Eli Lilly (NYSE:LLY) ha annunciato risultati positivi della fase 3 dello studio ATTAIN-1 per orforglipron, il suo agonista orale del recettore GLP-1 in fase di sperimentazione per il trattamento dell'obesit脿. La compressa da assumere una volta al giorno ha mostrato una perdita di peso significativa, con i partecipanti che hanno assunto la dose pi霉 alta (36 mg) che hanno perso in media 27,3 libbre (12,4%) rispetto a 2,2 libbre (0,9%) con il placebo in 72 settimane.
Lo studio, che ha coinvolto 3.127 adulti, ha raggiunto tutti gli endpoint primari e secondari. Alla dose pi霉 alta, il 59,6% dei partecipanti ha perso 鈮�10% del peso corporeo e il 39,6% ha perso 鈮�15%. Il farmaco ha anche mostrato miglioramenti nei marcatori di rischio cardiovascolare, inclusa una riduzione del 47,7% dei livelli di hsCRP. Il profilo di sicurezza 猫 risultato in linea con le terapie GLP-1 iniettabili, con effetti collaterali principalmente gastrointestinali.
Lilly prevede di presentare orforglipron per la revisione regolatoria entro la fine dell'anno e si sta preparando per un lancio globale.
Eli Lilly (NYSE:LLY) anunci贸 resultados positivos del ensayo de fase 3 ATTAIN-1 para orforglipron, su agonista oral del receptor GLP-1 en investigaci贸n para el tratamiento de la obesidad. La p铆ldora de una vez al d铆a demostr贸 una p茅rdida de peso significativa, con participantes que tomaron la dosis m谩s alta (36 mg) perdiendo un promedio de 27,3 libras (12,4%) en comparaci贸n con 2,2 libras (0,9%) con placebo durante 72 semanas.
El ensayo, que involucr贸 a 3.127 adultos, cumpli贸 con todos los objetivos primarios y secundarios. En la dosis m谩s alta, el 59,6% de los participantes perdi贸 鈮�10% del peso corporal y el 39,6% perdi贸 鈮�15%. El medicamento tambi茅n mostr贸 mejoras en los marcadores de riesgo cardiovascular, incluyendo una reducci贸n del 47,7% en los niveles de hsCRP. El perfil de seguridad fue consistente con las terapias inyectables de GLP-1, con efectos secundarios principalmente gastrointestinales.
Lilly planea presentar orforglipron para revisi贸n regulatoria antes de fin de a帽o y se est谩 preparando para un lanzamiento global.
Eli Lilly (NYSE:LLY)電� 牍勲 旃橂毳� 鞙勴暅 瓴疥惮鞖� GLP-1 靾橃毄觳� 鞛戩毄鞝滌澑 orforglipron鞚� 3靸� ATTAIN-1 鞛勳儊鞁滍棙鞐愳劀 旮嶌爼鞝侅澑 瓴瓣臣毳� 氚滍憸頄堨姷雼堧嫟. 頃橂（ 頃� 氩� 氤奠毄頃橂姅 鞚� 鞎届潃 臧�鞛� 雴掛潃 鞖╇焿(36mg)鞚� 氤奠毄頃� 彀戈皜鞛愲摛鞚� 72欤� 霃欖晥 韽夑窢 27.3韺岇毚霌�(12.4%)鞚� 觳挫 臧愳唽毳� 氤挫榾鞙茧┌, 鞙勳暯甑办潃 2.2韺岇毚霌�(0.9%) 臧愳唽鞐� 攴胳长鞀惦媹雼�.
3,127氇呾潣 靹膘澑鞚� 彀胳棳頃� 鞚措矆 鞛勳儊鞁滍棙鞚� 氇摖 欤检殧 氚� 攵�彀爜 氇╉憸毳� 雼劚頄堨姷雼堧嫟. 臧�鞛� 雴掛潃 鞖╇焿鞐愳劀電� 59.6%鞚� 彀戈皜鞛愱皜 觳挫鞚� 鈮�10%毳� 臧愲焿頄堨溂氅�, 39.6%電� 鈮�15%毳� 臧愲焿頄堨姷雼堧嫟. 霕愴暅 鞚� 鞎诫鞚� hsCRP 靾橃箻毳� 47.7% 臧愳唽鞁滍偆電� 霌� 鞁槇甏� 鞙勴棙 歆�響� 臧滌劆霃� 雮橅儉雰堨姷雼堧嫟. 鞎堨爠靹� 頂勲頃勳潃 欤检偓順� GLP-1 旃橂鞝滌檧 鞙犾偓頃橂┌, 欤茧 鞙勳灔 甏�霠� 攵�鞛戩毄鞚� 氤搓碃霅橃棃鞀惦媹雼�.
Lilly電� 鞐半旯岇 orforglipron鞚� 攴滌牅 鞁偓毳� 鞝滌稖頃� 瓿勴殟鞚措┌, 旮�搿滊矊 於滌嫓 欷�牍勲ゼ 歆勴枆 欷戩瀰雼堧嫟.
Eli Lilly (NYSE:LLY) a annonc茅 des r茅sultats positifs de l'essai de phase 3 ATTAIN-1 pour l'orforglipron, son agoniste oral du r茅cepteur GLP-1 en cours d'investigation pour le traitement de l'ob茅sit茅. Ce comprim茅 脿 prise quotidienne a d茅montr茅 une perte de poids significative, les participants ayant pris la dose la plus 茅lev茅e (36 mg) perdant en moyenne 27,3 livres (12,4%) contre 2,2 livres (0,9%) avec le placebo sur 72 semaines.
L'essai, impliquant 3 127 adultes, a atteint tous les crit猫res principaux et secondaires. 脌 la dose la plus 茅lev茅e, 59,6% des participants ont perdu 鈮�10% de leur poids corporel, et 39,6% ont perdu 鈮�15%. Le m茅dicament a 茅galement montr茅 des am茅liorations des marqueurs de risque cardiovasculaire, y compris une r茅duction de 47,7% des niveaux de hsCRP. Le profil de s茅curit茅 茅tait conforme 脿 celui des th茅rapies injectables GLP-1, avec principalement des effets secondaires gastro-intestinaux.
Lilly pr茅voit de soumettre l'orforglipron pour examen r茅glementaire d'ici la fin de l'ann茅e et se pr茅pare 脿 un lancement mondial.
Eli Lilly (NYSE:LLY) gab positive Ergebnisse der Phase-3-Studie ATTAIN-1 f眉r orforglipron bekannt, einen oralen GLP-1-Rezeptoragonisten in der Erforschung zur Behandlung von Adipositas. Die einmal t盲glich einzunehmende Tablette zeigte eine signifikante Gewichtsabnahme, wobei Teilnehmer, die die h枚chste Dosis (36 mg) erhielten, im Durchschnitt 27,3 Pfund (12,4%) verloren, verglichen mit 2,2 Pfund (0,9%) in der Placebogruppe 眉ber 72 Wochen.
Die Studie mit 3.127 Erwachsenen erreichte alle prim盲ren und sekund盲ren Endpunkte. Bei der h枚chsten Dosis verloren 59,6% der Teilnehmer 鈮�10% ihres K枚rpergewichts, und 39,6% verloren 鈮�15%. Das Medikament zeigte zudem Verbesserungen bei kardiovaskul盲ren Risikomarkern, darunter eine 47,7% Reduktion der hsCRP-Werte. Das Sicherheitsprofil entsprach dem von injizierbaren GLP-1-Therapien, mit 眉berwiegend gastrointestinalen Nebenwirkungen.
Lilly plant, orforglipron bis Jahresende zur beh枚rdlichen Pr眉fung einzureichen und bereitet sich auf eine weltweite Markteinf眉hrung vor.
- Significant weight loss of 27.3 lbs (12.4%) achieved with highest dose vs 2.2 lbs with placebo
- 59.6% of participants on highest dose lost 鈮�10% body weight, 39.6% lost 鈮�15%
- Improvements in cardiovascular risk markers, including 47.7% reduction in hsCRP levels
- Once-daily oral administration without food/water restrictions offers convenience over injectables
- Regulatory submission planned by year-end, indicating confidence in results
- Higher treatment discontinuation rates due to adverse events (10.3% at highest dose vs 2.6% placebo)
- Significant gastrointestinal side effects reported (33.7% nausea, 25.4% constipation at highest dose)
- Overall discontinuation rate of 24.4% at highest dose indicates tolerability challenges
Insights
Lilly's oral GLP-1 achieves impressive 27.3 lb weight loss in Phase 3, potentially disrupting injectable dominance with convenient pill format.
Lilly's Phase 3 ATTAIN-1 trial results for oral GLP-1 receptor agonist orforglipron represent a significant breakthrough in obesity treatment. The highest dose (36mg) achieved an impressive
The dose-dependent response across the three tested doses (6mg, 12mg, and 36mg) demonstrates robust clinical validity. Nearly
The results also show cardiometabolic benefits beyond weight loss, with improvements in non-HDL cholesterol, triglycerides, systolic blood pressure, and a
The safety profile aligns with the GLP-1 class, primarily gastrointestinal side effects like nausea (28.9-35.9%), constipation (21.7-29.8%), and vomiting (13-24%) versus much lower rates with placebo. Treatment discontinuation due to adverse events was dose-dependent (5.1-10.3%), but overall discontinuation rates were actually lower than placebo, suggesting good tolerability despite GI events.
With regulatory submissions planned by year-end and Lilly making "substantial investments" for anticipated demand, orforglipron could potentially launch in late 2026, disrupting the rapidly growing obesity market currently dominated by injectables.
The Phase 3 ATTAIN-1 results for Lilly's oral GLP-1 orforglipron represent a potential market inflection point in the obesity treatment landscape. The oral administration route eliminates a key barrier to widespread adoption that currently exists with injectable GLP-1s like Wegovy and Zepbound, potentially expanding the addressable patient population significantly.
With obesity affecting over one billion people globally, the market opportunity is enormous. The efficacy demonstrated (up to
Lilly's statement about making "substantial investments to meet anticipated demand" signals their confidence in orforglipron becoming a blockbuster therapy. This investment strategy reflects lessons learned from the supply constraints that hampered the launches of Wegovy and Zepbound.
The cardiovascular risk marker improvements (non-HDL cholesterol, triglycerides, blood pressure, and hsCRP) strengthen the drug's value proposition to payers, potentially supporting favorable reimbursement decisions. These markers correlate with reduced long-term healthcare costs from obesity-related comorbidities.
While the gastrointestinal side effect profile mirrors injectable GLP-1s, the overall discontinuation rates (
With planned regulatory submissions by year-end, Lilly appears positioned to potentially capture significant market share in what has become one of the pharmaceutical industry's fastest-growing therapeutic areas.
In ATTAIN-1, the investigational once-daily oral pill showed significant efficacy, and a safety and tolerability profile consistent with injectable GLP-1 therapies at 72 weeks
Orforglipron achieved the primary and all key secondary endpoints, including demonstrating improvements in a number of cardiovascular risk factors
With these results, Lilly is on track to submit orforglipron to global regulatory agencies by year-end and is making substantial investments to meet anticipated demand at launch
"Obesity is one of the most pressing global health challenges of our time, driving global chronic disease burden and impacting more than one billion people worldwide," said Kenneth Custer, Ph.D., executive vice president and president of Lilly Cardiometabolic Health. "With orforglipron, we're working to transform obesity care by introducing a potential once-daily oral therapy that could support early intervention and long-term disease management, while offering a convenient alternative to injectable treatments. With these positive data in hand, we are now planning to submit orforglipron for regulatory review by year-end and are prepared for a global launch to address this urgent public health need."
In the ATTAIN-1 trial, orforglipron met the primary endpoint of superior body weight reduction compared to placebo. Participants taking the highest dose of orforglipron lost an average of 27.3 lbs (
Efficacy Estimand Results | ||||
Orforglipron 6 mg | Orforglipron 12 mg | Orforglipron 36 mg | Placebo | |
Primary Endpoint | ||||
Mean percent change in | - 听 (-8.0 kg; -17.6 lbs) | - 听 (-9.4 kg; -20.7 lbs) | - 听 (-12.4 kg; -27.3 lbs) | - 听 (-1.0 kg; -2.2 lbs) |
Key Secondary Endpoints | ||||
Percentage of | 35.9听% | 45.1听% | 59.6听% | 8.6听% |
Percentage of | 16.5听% | 24.0听% | 39.6听% | 3.6听% |
iSuperiority test was adjusted for multiplicity. |
For the treatment-regimen estimand,2 each dose of orforglipron led to statistically significant improvements across the primary and all key secondary endpoints.
- Percent weight reduction: -
7.5% (-7.8 kg; 17.2 lbs; 6 mg), -8.4% (-8.6 kg; 19.0 lbs; 12 mg), -11.2% (-11.3 kg; 25.0 lbs; 36 mg), -2.1% (-2.4 kg; 5.3 lbs; placebo) - Percentage of participants achieving body weight reductions of 鈮�
10% :33.3% (6 mg),40.0% (12 mg),54.6% (36 mg),12.9% (placebo) - Percentage of participants achieving body weight reductions of 鈮�
15% :15.1% (6 mg),20.3% (12 mg),36.0% (36 mg),5.9% (placebo)
The overall safety profile of orforglipron in ATTAIN-1 was consistent with the established GLP-1 receptor agonist class. The most commonly reported adverse events were gastrointestinal-related and generally mild-to-moderate in severity. The most common adverse events for participants treated with orforglipron (6 mg, 12 mg and 36 mg, respectively) were nausea (
The detailed ATTAIN-1 results will be presented next month at the听European Association for the Study of Diabetes听(EASD) Annual Meeting 2025 and published in a peer-reviewed journal. More results from the ATTAIN Phase 3 clinical trial program will be shared later this year, along with findings from the ACHIEVE Phase 3 clinical trial program evaluating orforglipron for adults with type 2 diabetes.
About orforglipron听
Orforglipron (or-for-GLIP-ron) is an investigational, once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.3 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. Chugai and Lilly published the preclinical pharmacology data of this molecule together.4 Lilly is running Phase 3 studies on orforglipron for the treatment of type 2 diabetes and for weight management in adults with obesity or overweight with at least one weight-related medical problem. It is also being studied as a potential treatment for obstructive sleep apnea (OSA) and hypertension in adults with obesity.
About ATTAIN-1 and ATTAIN clinical trial program听
ATTAIN-1 (NCT05869903) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of orforglipron 6 mg, 12 mg and 36 mg as monotherapy to placebo in adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, OSA听or cardiovascular disease, who did not have diabetes.听The trial randomized 3,127 participants across the
The ATTAIN Phase 3 global clinical development program for orforglipron has enrolled more than 4,500 people with obesity or overweight across two global registration trials. The program began in 2023 with additional results anticipated this year.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit听 and听, or follow us on听, and . P-LLY
Endnotes and References:
- The efficacy听estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 72 weeks without initiating prohibited weight management treatments.
- The treatment-regimen听estimand represents the estimated average treatment effect regardless of adherence to study intervention or initiation of prohibited weight management treatments.
- Ma X,听Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. doi: 10.1007/s13300-024-01554-1. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152.
- T. Kawai, B. Sun, H. Yoshino, D. Feng, Y. Suzuki, M. Fukazawa, S. Nagao, D.B. Wainscott, A.D. Showalter, B.A. Droz, T.S. Kobilka, M.P. Coghlan, F.S. Willard, Y. Kawabe, B.K. Kobilka, & K.W. Sloop, Structural basis for GLP-1 receptor activation by LY3502970, an orally active nonpeptide agonist, Proc. Natl. Acad. Sci.
U.S.A. 117 (47) 29959-29967, https://doi.org/10.1073/pnas.2014879117 (2020).
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about orforglipron as a potential treatment for adults with obesity or overweight, Lilly's ability to supply orforglipron, if approved, and the timeline for future readouts, presentations, and other milestones relating to orforglipron and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that orforglipron will prove to be a safe and effective treatment for obesity or overweight, that orforglipron will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.听
Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the 庐 and 鈩� symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
Refer to: | Brooke Frost; [email protected]; 317-432-9145 (Media) |
Michael Czapar; [email protected]; 317-617-0983 (Investors) |
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