Lilly's selective amylin agonist, eloralintide, demonstrated meaningful weight loss and favorable tolerability in a Phase 2 study of adults with obesity or overweight
Eli Lilly (NYSE: LLY) reported positive Phase 2 results for eloralintide, a once-weekly selective amylin receptor agonist, in 263 adults with obesity or overweight without type 2 diabetes, announced Nov 6, 2025.
At 48 weeks all eloralintide arms met the primary endpoint with mean weight reductions ranging from 9.5% to 20.1% versus 0.4% for placebo; absolute losses spanned 10.2 kg to 21.3 kg. Adverse events were mainly mild–moderate GI symptoms and fatigue, higher at larger doses and reduced with slower escalation. Lilly plans to begin Phase 3 enrollment by year-end and is evaluating eloralintide alone and as a complement to incretin therapy.
Eli Lilly (NYSE: LLY) ha riportato risultati positivi di fase 2 per eloralintide, un agonista selettivo del recettore dell’amilina somministrato una volta a settimana, in 263 adulti con obesità o sovrappeso senza diabete di tipo 2, comunicato il 6 novembre 2025.
A 48 settimane tutti i bracci di eloralintide hanno raggiunto l’obiettivo primario con perdite di peso medie che vanno dal 9,5% al 20,1% rispetto al 0,4% del placebo; le perdite assolute sono andate da 10,2 kg a 21,3 kg. Gli eventi avversi sono stati principalmente sintomi GI lievi–moderati e affaticamento, più elevati a dosi maggiori e ridotti con una progressione più lenta. Lilly prevede di iniziare l’arruolamento negli studi di fase 3 entro la fine dell’anno e sta valutando eloralintide da solo e in complemento alla terapia incretina.
Eli Lilly (NYSE: LLY) informó resultados positivos de fase 2 para eloralintide, un agonista selectivo del receptor de amilina, de una vez por semana, en 263 adultos con obesidad o sobrepeso sin diabetes tipo 2, anunciado el 6 de noviembre de 2025.
A 48 semanas todos los brazos de eloralintide cumplieron el objetivo primario con reducciones medias de peso que oscilan entre 9,5% y 20,1% frente a 0,4% para el placebo; las pérdidas absolutas oscilaron entre 10,2 kg y 21,3 kg. Los eventos adversos fueron principalmente síntomas gastrointestinales leves a moderados y fatiga, mayores a dosis más altas y reducidos con una escalada más lenta. Lilly planea iniciar la inscripción en fase 3 a finales de año y está evaluando eloralintide solo y como complemento a la terapia incretina.
일라이 릴리(Eli Lilly, NYSE: LLY)는 2상 양성 결과를 보고했습니다. eloralintide는 주 1회 선택적 아밀린 수용체 작용제로서, 2025년 11월 6일 발표된 바와 같이 당뇨병 2형이 없는 비만 또는 과체중 성인 263명을 대상으로 한 연구입니다.
48주째에 eloralintide의 모든 군은 1차 종목을 달성했고 평균 체중 감소는 9.5%에서 20.1% 사이였으며 위약은 0.4%였습니다; 절대 감소량은 10.2 kg에서 21.3 kg에 이르는 것으로 나타났습니다. 이상 반응은 주로 경증-중등도 위장계 증상과 피로였고, 용량이 커질수록 더 많았고 증가를 더 느리게 하여 감소시켰습니다. Lilly는 연내 3상 등록을 시작하고 있으며, eloralintide 단독 요법과 인크레틴 치료 보조로의 병용을 평가 중입니다.
Eli Lilly (NYSE : LLY) a annoncé des résultats positifs de phase 2 pour l'eloralintide, un agoniste sélectif du récepteur de l’amyline administré une fois par semaine, chez 263 adultes obèses ou en surpoids sans diabète de type 2, annoncé le 6 novembre 2025.
À 48 semaines, tous les bras de l’eloralintide ont atteint l’objectif primaire avec des réductions moyen de poids allant de 9,5% à 20,1% contre 0,4% pour le placebo ; les pertes absolues variaient de 10,2 kg à 21,3 kg. Les événements indésirables étaient principalement des symptômes GI légers à modérés et de la fatigue, plus élevés à des doses plus élevées et diminués par une escalade plus lente. Lilly prévoit d’ouvrir le recrutement pour la phase 3 d’ici la fin de l’année et évalue l’eloralintide seul et en complément de la thérapie incretine.
Eli Lilly (NYSE: LLY) meldete positive Phase-2-Ergebnisse für Eloralintide, einen wöchentlich verabreichten, selektiven Amylinrezeptor-Agonisten, bei 263 Erwachsenen mit Adipositas oder Übergewicht ohne Typ-2-Diabetes, angekündigt am 6. November 2025.
Nach 48 Wochen haben alle Eloralintide-Arme den primären Endpunkt erreicht, mit durchschnittlichen Gewichtsreduktionen von 9,5% bis 20,1% gegenüber 0,4% für Placebo; absolute Verluste lagen zwischen 10,2 kg und 21,3 kg. Zu den Nebenwirkungen gehörten hauptsächlich milde bis mäßige GI-Symptome und Müdigkeit, höher bei größeren Dosen und reduziert durch eine langsamere Hochstufung. Lilly plant, die Phase-3-Rekrutierung bis zum Jahresende zu beginnen und bewertet Eloralintide sowohl allein als auch als Ergänzung zur Inkretintherapie.
إيلي ليلي (NYSE: LLY) أعلنت نتائج إيجابية للمرحلة 2 لدواء eloralintide، وهو منبه مستقبل الأميلين الانتقائي، مرة واحدة أسبوعيًا، في 263 بالغًا يعانون من السمنة أو زيادة الوزن دون مرض السكري من النوع 2، كما أُعلن في 6 نوفمبر 2025.
بعد 48 أسبوعًا، حققت جميع أذرع eloralintide الهدف الأولي مع انخفاضات متوسطة في الوزن تتراوح بين 9.5% إلى 20.1% مقارنة بـ 0.4% للعلاج الوهمي؛ فُقدان مطلق يتراوح بين 10.2 كغم إلى 21.3 كغم. وكانت الأحداث الضارة في الغالب مصاحبة لأعراض جهاز هضمي خفيفة إلى معتدلة وتعب، وتكون أعلى عند الجرعات الأكبر وتقل مع التصعيد الأبطأ. تخطط ليلي لبدء التسجيل في المرحلة 3 بحلول نهاية السنة وتقيّم eloralintide وحده وبصفته مكملًا لعلاج الإنكريتين.
- Mean weight reduction up to 20.1% at 48 weeks
- 21.3 kg maximum mean absolute weight loss reported
- Phase 3 enrollment planned to begin by year-end 2025
- Improvements across cardiometabolic risk factors reported
- Higher-dose arms had increased mild–moderate gastrointestinal events
- Adverse events more frequent at higher doses despite efficacy
Insights
Phase 2 shows robust, dose‑responsive weight loss and tolerability that justify rapid Phase 3 initiation.
All randomized eloralintide arms met the primary endpoint at 48 weeks, with mean weight reductions ranging from
The program’s near‑term success depends on maintaining this efficacy and tolerability in larger, more diverse populations and on prespecified multiplicity control in pivotal analyses; the press release notes endpoints used the efficacy estimand and were not adjusted for multiplicity. Watch for confirmatory Phase 3 data readouts and detailed safety tables including discontinuation rates, serious adverse events, and subgroup analyses over the next
Eloralintide could expand obesity treatment choices if Phase 3 reproduces strong weight loss with improved tolerability.
The reported mean losses of
Key commercial milestones to monitor include Phase 3 enrollment start and design, comparator or add‑on arms to incretin drugs, prespecified primary endpoints and multiplicity control, and longer safety follow‑up; expect these items disclosed with trial registries and regulatory briefing materials over the next
Based on these trial results, Lilly will begin enrolling Phase 3 clinical studies for the treatment of obesity next month
"Obesity is a complex condition, and no single treatment works for everyone. To truly address each patient's needs, we need therapies with different mechanisms of action so that each person can receive the treatment that offers the best balance of effectiveness and tolerability for them," said Liana K. Billings, M.D., Director of Clinical and Genetics Research in Diabetes and Cardiometabolic Disease at Endeavor Health,
In the trial, all doses of eloralintide delivered clinically meaningful improvements compared to placebo for the secondary endpoints of reductions in body weight and body mass index. Treatment with eloralintide was also associated with improvements across cardiometabolic risk factors including waist circumference, blood pressure, lipid profiles, glycemic control and markers of inflammation.
Phase 2 Results
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Primary Endpoint: Mean percent change in body weight from avg. baseline of 109.1 kg (240.5 lbs)i |
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Eloralintide 1 mg |
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Eloralintide 3 mg |
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Eloralintide 6 mg |
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Eloralintide 9 mg |
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Eloralintide 6/9 mg |
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Eloralintide 3/6/9 mg |
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Placebo |
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i Endpoints are assessed with the efficacy estimand and not adjusted for multiplicity. |
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The most common adverse events were mild to moderate gastrointestinal symptoms and fatigue, which were seen more frequently in the higher dose arms. The incidence of these adverse events were lower with slower dose escalation and were similar to placebo for the 1 mg and 3 mg arms.
"Lilly is advancing the most comprehensive pipeline of obesity medicines, with a commitment to deliver innovative treatments that reflect the diverse needs and preferences of people living with obesity. We believe that molecule specificity is important in this class," said Kenneth Custer, Ph.D., executive vice president and president of Lilly Cardiometabolic Health. "These data show that eloralintide, a selective amylin receptor agonist, offers the potential for strong efficacy with improved tolerability and could serve as an alternative to incretin therapies. We also are optimistic that it could be a complementary option for patients that need higher levels of efficacy. Based on the encouraging results from Phase 2 trials of eloralintide, we plan to begin Phase 3 enrollment by year-end."
Lilly plans to initiate Phase 3 clinical studies of eloralintide as a monotherapy for the treatment of obesity by the end of this year and is evaluating its use as a complementary treatment to incretin therapy.
About eloralintide
Eloralintide is an investigational once-weekly, selective amylin receptor agonist previously known as LY3841136.2,3 Eloralintide has the potential to decrease calorie intake, and the effects are likely mediated by affecting satiety, or the feeling of fullness. Lilly is also conducting a Phase 2 study (NCT06603571) evaluating eloralintide, alone or in combination, with tirzepatide for weight management in adults with obesity or overweight and type 2 diabetes.
About the study
The Phase 2 study (NCT06230523) was a 48-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of once-weekly eloralintide monotherapy with placebo in adults with obesity or overweight and at least one weight-related comorbidity and without type 2 diabetes. The trial randomized 263 participants across the
Endnotes and References
- The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and/or dose modifications) for 48 weeks.
- Briere DA, Long A, Bullock DM, et al. 849-P: Eloralintide (LY3841136), a Selective Amylin Mimetic, Lowered Body Weight with Improved Quality of Weight Loss and GI Tolerability in Rats Compared with Cagrilintide. Diabetes 2025;74 (Supplement_1):849-P. https://doi.org/10.2337/db25-849-P
- Bhattachar SN, Tham L-S, Tidemann-Miller B, et al. 882-P: Eloralintide, a Selective, Long-Acting Amylin Receptor Agonist for Obesity—Phase 1 Proof of Concept. Diabetes 2025;74. (Supplement_1):882-P. https://doi.org/10.2337/db25-882-P
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 Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY
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 ® and ™ 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.
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 eloralintide as a potential treatment for adults with obesity or overweight, and the timeline for future clinical studies, presentations, and other milestones relating to eloralintide 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 eloralintide will prove to be a safe and effective treatment for obesity or overweight, that eloralintide 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.
Refer to: Brooke Frost; brooke.frost@lilly.com; 317-432-9145 (Media)
Michael Czapar; czapar_michael_c@lilly.com; 317-617-0983 (Investors)
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SOURCE Eli Lilly and Company
FAQ
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