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Foundayo 17.2 mg was associated with 1.5% greater weight loss and 0.3% greater A1C reduction than oral semaglutide 25 mg at 52 weeks
在第52周时,与25毫克口服司美格鲁肽相比,17.2毫克Foundayo与多1.5%的体重减轻和多0.3%的糖化血红蛋白(A1C)降低相关。
These additional analyses build on findings of the ACHIEVE-3 head-to-head study, where Foundayo 9 mg and 17.2 mg delivered greater A1C and weight reductions than oral semaglutide 14 mg
这些补充分析基于ACHIEVE-3头对头研究的结果,该研究显示,与口服司美格鲁肽14 mg相比,Foundayo 9 mg和17.2 mg能带来更大的糖化血红蛋白(A1C)降幅和体重减轻。
INDIANAPOLIS
印第安纳波利斯
,
,
Sept. 29, 2026
2026年9月29日
/PRNewswire/ -- Eli Lilly and Company (NYSE:
/美通社/ -- 礼来公司(纽约证券交易所:
LLY
礼来
), the maker of Zepbound (tirzepatide), today announced results from a new analysis showing that Foundayo (orforglipron) 17.2 mg was associated with significantly greater weight loss and better blood sugar control than oral semaglutide 25 mg in adults with type 2 diabetes. The findings are based on an indirect treatment comparison of Foundayo 17.2 mg against oral semaglutide 25 mg, drawing on data from ACHIEVE-3 and PIONEER PLUS..
Zepbound(替尔泊肽)的制造商今日公布了一项新分析的结果,显示在2型糖尿病成人患者中,Foundayo(orforglipron)17.2 mg与口服司美格鲁肽25 mg相比,可显著减轻体重并更好地控制血糖。该结果基于对Foundayo 17.2 mg与口服司美格鲁肽25 mg进行的间接治疗比较,数据来源于ACHIEVE-3和PIONEER PLUS研究。
1,2,3,4
1,2,3,4
Presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Milan, Italy, these results add to a growing body of evidence supporting Foundayo's efficacy.
这些结果在意大利米兰举行的欧洲糖尿病研究协会(EASD)第62届年会上发布,进一步充实了支持Foundayo疗效的日益增多的证据。
'For someone managing type 2 diabetes, the choice between treatments is a decision that impacts their life every day,' said Deborah Horn, D.O., director of the Center for Obesity Medicine at McGovern Medical School at UTHealth Houston. 'Having data to help us compare available medications provides clinicians the opportunity to make informed treatment choices that fit each patient's needs.'.
“对于2型糖尿病患者而言,治疗方案的选择是一项每天都会影响其生活的决策。”德博拉·霍恩(Deborah Horn)博士表示,她是休斯顿德克萨斯大学健康科学中心麦戈文医学院肥胖医学中心的主任。“拥有帮助我们比较现有药物的数据,使临床医生有机会根据每位患者的需求做出明智的治疗选择。”
In an indirect treatment comparison using data from ACHIEVE-3 and PIONEER PLUS, Foundayo 17.2 mg showed significantly greater weight loss and A1C reduction compared to oral semaglutide 25 mg at 52 weeks.
在使用 ACHIEVE-3 和 PIONEER PLUS 研究数据进行的间接治疗比较中,与口服司美格鲁肽 25 mg 相比,Foundayo 17.2 mg 在 52 周时显示出显著更大的体重减轻和糖化血红蛋白(A1C)降低。
5
5
On average, participants taking Foundayo 17.2 mg lost 1.5% more of their body weight compared to oral semaglutide 25 mg (95% CI -2.7%, -0.2%). Additionally, Foundayo lowered A1C by 0.3% more than oral semaglutide 25 mg (95% CI -0.6%, -0.1%). This analysis was covariate-adjusted for gender, age, baseline A1C and baseline weight.
平均而言,与口服25 mg司美格鲁肽相比,服用17.2 mg Foundayo的参与者体重多减轻了1.5%(95%置信区间:-2.7%,-0.2%)。此外,Foundayo使糖化血红蛋白(A1C)较口服25 mg司美格鲁肽多降低0.3%(95%置信区间:-0.6%,-0.1%)。该分析对性别、年龄、基线A1C和基线体重进行了协变量调整。
Analyses using different statistical methods produced consistent results, with Foundayo 17.2 mg showing 1.5% to 2.4% greater weight loss and 0.3% to 0.6% greater A1C reduction compared to oral semaglutide 25 mg. .
采用不同统计方法进行的分析结果一致,与25 mg口服司美格鲁肽相比,17.2 mg Foundayo显示出多1.5%至2.4%的体重减轻和多0.3%至0.6%的糖化血红蛋白(A1C)降低。
'Head-to-head trials ultimately provide the best comparison of two medicines, but when we don't yet have those data, then other approaches can provide informative data points,' said Rachel Batterham, OBE, MBBS, Ph.D., FRCP, senior vice president of medical innovation and external engagement, Lilly Cardiometabolic Health.
“头对头试验最终能为两种药物提供最佳比较,但在我们尚未获得此类数据时,其他方法也能提供具有参考价值的信息点。”礼来公司心血管代谢健康部门医学创新与对外合作高级副总裁雷切尔·巴特汉姆(Rachel Batterham,OBE,MBBS,Ph.D.,FRCP)表示。
'Results from this indirect treatment comparison suggest that Foundayo may deliver A1C and weight lowering that is similar to the 25 mg dose of oral semaglutide. These results, paired with simple administration free of fasting or water restrictions, are what make Foundayo a potentially foundational therapy for adults managing type 2 diabetes around the world.'.
“这项间接治疗比较的结果表明,Foundayo在降低糖化血红蛋白(A1C)和体重方面的效果可能与25毫克剂量的口服司美格鲁肽相似。这些结果,加上无需禁食或限制饮水的简便给药方式,使Foundayo有望成为全球成人2型糖尿病管理的基础性治疗药物。”
About Foundayo
关于 Foundayo
(orforglipron)
(奥福格列普隆)
Foundayo (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems, to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a 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. Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd.
Foundayo(orforglipron)已获美国食品药品监督管理局(FDA)批准,用于肥胖症成人患者,或伴有体重相关医学问题的部分超重成人患者,在减少热量饮食和增加体力活动的基础上,减轻多余体重并长期维持减重效果。Foundayo 是一种每日一次的小分子(非肽类)口服胰高血糖素样肽-1受体激动剂,可在一天中的任何时间服用,不受进食和饮水限制。Orforglipron 由中外制药株式会社发现。
and licensed by Lilly in 2018. Orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence. .
并于2018年获得礼来公司授权。Orforglipron 正在作为2型糖尿病、阻塞性睡眠呼吸暂停、膝骨关节炎疼痛、高血压、外周动脉疾病和压力性尿失禁的潜在治疗方案进行研究。
About ACHIEVE-3 and ACHIEVE clinical trial program
关于 ACHIEVE-3 和 ACHIEVE 临床试验项目
ACHIEVE-3 (NCT06045221) is a Phase 3, 52-week, randomized, open-label trial evaluating the efficacy and safety of orforglipron compared with oral semaglutide (Rybelsus) in adults with type 2 diabetes inadequately controlled with metformin. The trial randomized 1,698 participants across the U.S., Argentina, China, Japan, Mexico and Puerto Rico to receive either 9 mg or 17.2 mg orforglipron or 7 mg or 14 mg oral semaglutide in a 1:1:1:1 ratio.
ACHIEVE-3(NCT06045221)是一项为期52周的III期、随机、开放标签试验,旨在评估orforglipron与口服司美格鲁肽(Rybelsus)在二甲双胍控制不佳的2型糖尿病成人患者中的疗效和安全性。该试验在美国、阿根廷、中国、日本、墨西哥和波多黎各招募了1,698名受试者,并按1:1:1:1的比例随机分配接受9 mg或17.2 mg orforglipron,或7 mg或14 mg口服司美格鲁肽治疗。
The primary objective of the study was to demonstrate that orforglipron is non-inferior in A1C reduction from baseline after 52 weeks compared with oral semaglutide when comparing the lower and higher doses..
本研究的主要目的是证明,在比较较低和较高剂量时,orforglipron 在治疗 52 周后降低糖化血红蛋白(A1C)的效果不劣于口服司美格鲁肽。
In ACHIEVE-3, Foundayo lowered A1C by an average of 1.9% (9 mg) and 2.2% (17.2 mg) compared to 1.1% (7 mg) and 1.4% (14 mg) with oral semaglutide at 52 weeks. Foundayo also delivered greater weight loss, with participants losing an average of 14.6 lbs (6.7%; 9 mg) and 19.7 lbs (9.2%; 17.2 mg) compared to 7.9 lbs (3.7%; 7 mg) and 11.0 lbs (5.3%; 14 mg) with oral semaglutide..
在 ACHIEVE-3 研究中,与口服司美格鲁肽相比,Foundayo 在第 52 周时将糖化血红蛋白(A1C)平均降低了 1.9%(9 mg 剂量)和 2.2%(17.2 mg 剂量),而口服司美格鲁肽(7 mg 和 14 mg 剂量)的降低幅度分别为 1.1% 和 1.4%。Foundayo 还带来了更大的体重减轻,参与者平均减重 14.6 磅(6.7%;9 mg 剂量)和 19.7 磅(9.2%;17.2 mg 剂量),而口服司美格鲁肽(7 mg 和 14 mg 剂量)组的平均减重分别为 7.9 磅(3.7%)和 11.0 磅(5.3%)。
The ACHIEVE Phase 3 global clinical development program for orforglipron enrolled more than 6,000 people with type 2 diabetes across five global registration trials.
ACHIEVE 3期全球临床开发计划针对orforglipron,在五项全球注册试验中招募了超过6,000名2型糖尿病患者。
Endnotes and References
尾注与参考文献
Rosenstock J, Yabe D, Cox D, et al. Efficacy and safety of once-daily oral orforglipron compared with oral semaglutide in adults with type 2 diabetes (ACHIEVE-3): a multinational, multicentre, non-inferiority, open-label, randomised, phase 3 trial. Lancet. 2026 Mar 21;407(10534):1147-1160.
Rosenstock J, Yabe D, Cox D, 等. 每日一次口服orforglipron与口服司美格鲁肽在2型糖尿病成人中的疗效和安全性(ACHIEVE-3):一项多国、多中心、非劣效性、开放标签、随机、3期试验。《柳叶刀》. 2026年3月21日;407(10534):1147-1160.
https://doi.org/10.1016/S0140-6736(26)00202-3
https://doi.org/10.1016/S0140-6736(26)00202-3
. Epub 2026 Feb 26. PMID: 41765029.
电子出版 2026年2月26日。PMID: 41765029。
Aroda V, Aberle J, Bardtrum L, et al. Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial. The Lancet, 2023; 402, 693-704.
Aroda V, Aberle J, Bardtrum L, 等. 每日一次口服司美格鲁肽25 mg和50 mg与14 mg在成人2型糖尿病患者中的疗效和安全性(PIONEER PLUS):一项多中心、随机、3b期临床试验。《柳叶刀》,2023;402,693-704。
https://doi.org/10.1016/s0140-6736(23)01127-3
https://doi.org/10.1016/s0140-6736(23)01127-3
Cheng A, Jacobi D, Mojdami D, Li J, Li J, Zhao Y, Terrell K, Liu-Seifert H. Oral orforglipron 17.2 mg versus oral semaglutide 25 mg in adults with type 2 diabetes and BMI ≥25kg/m
Cheng A, Jacobi D, Mojdami D, Li J, Li J, Zhao Y, Terrell K, Liu-Seifert H. 口服orforglipron 17.2 mg对比口服司美格鲁肽25 mg在成人2型糖尿病且BMI ≥25kg/m²患者中的疗效
2
2
: an indirect treatment comparison.
:一项间接治疗比较。
A 25 mg once-daily dose of oral semaglutide is not approved in the United States for the treatment of type 2 diabetes. Novo Nordisk has submitted an application to the FDA seeking approval of that dose.
在美国,每日一次25毫克的口服司美格鲁肽剂量尚未获批用于2型糖尿病的治疗。诺和诺德已向美国食品药品监督管理局(FDA)提交申请,寻求批准该剂量。
All data referenced in this press release are based on the efficacy estimand. In ACHIEVE-3, the efficacy estimand represents treatment efficacy had all randomized participants remained on study intervention (with possible dose interruptions and/or dose modifications) for 52 weeks without initiating additional antihyperglycemic medications (>14 days of use).
本新闻稿中引用的所有数据均基于疗效 estimand。在 ACHIEVE-3 研究中,疗效 estimand 代表的是:如果所有随机分组的受试者在不启动额外降糖药物(使用超过14天)的情况下,持续接受研究干预治疗(允许剂量中断和/或剂量调整)52周,所体现的治疗效果。
In PIONEER PLUS, the corresponding estimand is termed as the trial product estimand in the manuscript..
在PIONEER PLUS研究中,相应的估计量在文稿中被称为试验产品估计量。
U.S. FOUNDAYO INDICATION AND SAFETY SUMMARY WITH WARNINGS
美国 FOUNDAYO 适应症与安全概要(含警告)
Foundayo (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.
Foundayo(发音:fown-DAY-oh)是一种处方药,配合低热量饮食和增加体力活动,用于帮助肥胖症成人,或伴有体重相关医学问题的部分超重成人,减轻多余体重并维持减重效果。
Foundayo should not be used with other
Foundayo 不应与其他
GLP-1
GLP-1
receptor agonist medicines.
受体激动剂药物。
It is not known if Foundayo is safe and effective for use in children.
目前尚不清楚 Foundayo 在儿童中的使用是否安全有效。
Warnings –
警告 –
Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.
Foundayo 可能导致甲状腺肿瘤,包括甲状腺癌。请留意可能出现的症状,如颈部肿块或肿胀、声音嘶哑、吞咽困难或呼吸短促。如果出现任何上述症状,请告知您的医疗保健提供者。
Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
如果您或您的任何家庭成员曾患有称为髓样甲状腺癌(MTC)的甲状腺癌,请勿使用 Foundayo。
Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
如果您患有2型多发性内分泌腺瘤病(MEN 2),请勿使用 Foundayo。
Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo.
如果您曾对奥福格列酮(orforglipron)或 Foundayo 的任何成分发生严重过敏反应,请勿使用 Foundayo。
Foundayo
Foundayo
may cause serious side effects, including:
可能引起严重的副作用,包括:
Inflammation of
炎症
the pancreas
胰腺
(pancreatitis).
(胰腺炎)。
Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.
如果您出现持续不缓解的严重腹痛(腹部疼痛),无论是否伴有恶心或呕吐,请立即停用 Foundayo 并马上联系您的医疗保健提供者。有时,您可能会感到腹痛放射至背部。
Severe stomach problems.
严重的胃部问题。
Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
使用 Foundayo 的人群中曾有胃部问题的报告,有时可能较为严重。如果您出现严重或持续不缓解的胃部问题,请告知您的医疗保健提供者。
Dehydration
脱水
leading
领先
to kidney problems.
导致肾脏问题。
Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.
腹泻、恶心和呕吐可能导致体液流失(脱水),从而引发肾脏问题。重要的是,您应补充液体,以降低脱水的风险。如果出现持续不缓解的恶心、呕吐或腹泻,请立即告知您的医疗保健提供者。
Low blood sugar (hypoglycemia).
低血糖(低血糖症)。
Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea.
如果您将 Foundayo 与可能导致低血糖的药物(如胰岛素或磺酰脲类药物)联合使用,您发生低血糖的风险可能会更高。
Signs and symptoms of low blood sugar may include
低血糖的体征和症状可能包括
dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery.
头晕或头昏、出汗、意识模糊或嗜睡、头痛、视力模糊、言语不清、颤抖、心跳加快、焦虑、易怒、情绪变化、饥饿感、虚弱或感到坐立不安。
Serious allergic reactions.
严重过敏反应。
Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.
如果出现严重过敏反应的任何症状,包括面部、嘴唇、舌头或喉咙肿胀,呼吸或吞咽困难,严重皮疹或瘙痒,晕厥或感到头晕,以及心跳极快,请立即停止使用 Foundayo 并寻求医疗帮助。
Changes in vision in patients with type 2 diabetes.
2型糖尿病患者视力变化。
Tell your healthcare provider if you have changes in vision during treatment with Foundayo.
如果您在使用 Foundayo 治疗期间出现视力变化,请告知您的医疗保健提供者。
Gallbladder problems.
胆囊问题。
Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.
部分使用 Foundayo 的患者出现了胆囊问题。如果您出现胆囊问题的症状,包括上腹部疼痛、发热、皮肤或眼睛发黄(黄疸)或陶土色粪便,请立即告知您的医疗保健提供者。
Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).
在手术或其他使用麻醉或深度镇静(深睡状态)的操作过程中,食物或液体进入肺部。
Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures.
服用 Foundayo 可能会增加在手术或其他操作过程中食物进入肺部的风险。在安排手术或其他操作之前,请告知您的医疗保健提供者您正在服用 Foundayo。
Common side effects
常见副作用
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away. .
Foundayo 最常见的副作用包括恶心、便秘、腹泻、呕吐、消化不良、胃(腹部)疼痛、头痛、腹部肿胀、疲劳感、嗳气、胃灼热、胀气和脱发。这些并非 Foundayo 所有可能的副作用。如有任何令您困扰或持续不退的副作用,请咨询您的医疗保健提供者。
Tell your doctor if you have any side effects.
如果您出现任何副作用,请告知您的医生。
You can report side effects at 1-800-FDA-1088 or
您可以通过 1-800-FDA-1088 报告副作用,或
www.fda.gov/medwatch
www.fda.gov/medwatch
.
。
Before taking
在服用之前
Foundayo
方达约
Tell your healthcare provider about all the medicines you take.
请告知您的医疗保健提供者您正在服用的所有药物。
Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works.
Foundayo 可能会影响某些药物的作用方式,而某些药物也可能会影响 Foundayo 的作用方式。
Pregnancy Exposure Registry
妊娠暴露登记处
: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). .
将设立妊娠暴露登记处,用于记录在妊娠期间服用 Foundayo 的女性。该登记处的目的是收集有关您和您宝宝健康状况的信息。请与您的医疗保健提供者讨论如何参与该登记处,或您可以联系礼来公司(Eli Lilly and Company),电话:1-800-LillyRx(1-800-545-5979)。
If you take birth control pills by mouth, talk to your healthcare provider before you take
如果您口服避孕药,请在服用前咨询您的医疗保健提供者
Foundayo. Birth control pills may not work as well while taking
Foundayo。服用期间,避孕药的效果可能会降低。
Foundayo.
Foundayo。
Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo.
您的医疗保健提供者可能会建议在开始使用 Foundayo 后的 30 天内,以及每次增加 Foundayo 剂量后的 30 天内,采用另一种类型的避孕方法。
Talk to your healthcare provider about low blood sugar and how to manage it.
与您的医疗保健提供者讨论低血糖问题及其管理方法。
Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.
如果您正在服用治疗糖尿病的药物,包括胰岛素或磺酰脲类药物,请告知您的医疗保健提供者。
Review these questions with your healthcare provider:
与您的医疗保健提供者一起审查这些问题:
❑ Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ 您是否有其他疾病,包括胰腺或肾脏问题,或严重的肝脏问题、严重的胃部问题(如胃排空延迟[胃轻瘫]或食物消化障碍)?
❑ Do you have a history of diabetic retinopathy?
❑ 您是否有糖尿病视网膜病变病史?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ 您是否已安排进行需要使用麻醉或深度镇静(深睡状态)的手术或其他操作?
❑ Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby.
❑ 您是否怀孕或计划怀孕?Foundayo 可能会对您的胎儿造成伤害。
❑ Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo.
❑ 您是否正在哺乳或计划哺乳?在使用 Foundayo 治疗期间,不建议进行母乳喂养。
❑ Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements?
❑ 您是否正在服用其他处方药、非处方药、维生素或草本补充剂?
How to take
服用方法
Take Foundayo exactly as your healthcare provider tells you to.
请严格按照医疗保健提供者的指示服用 Foundayo。
Use Foundayo with a reduced-calorie diet and increased physical activity.
配合低热量饮食和增加体力活动使用 Foundayo。
Take Foundayo by mouth 1 time each day, with or without food.
每日口服一次 Foundayo,可与食物同服或空腹服用。
Swallow tablets whole. Do not break, crush, or chew the tablet.
整片吞服。请勿掰开、压碎或咀嚼药片。
If you miss a dose, take it as soon as possible.
如果漏服一剂,请尽快补服。
Do not
不要
take
拿
2
2
doses of Foundayo in the same day.
同一天内服用 Foundayo 的剂量。
Do not take more than 1 tablet per day.
每日服用不得超过1片。
If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment.
如果您连续7天或更长时间漏服Foundayo,请联系您的医疗保健提供者,讨论如何重新开始治疗。
If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
如果您服用了过量的 Foundayo,请立即联系您的医疗保健提供者或拨打中毒帮助热线 1-800-222-1222,或前往最近的医院急诊室。
Learn more
了解更多
Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to
Foundayo 是一种处方药,有 0.8 mg、2.5 mg、5.5 mg、9 mg、14.5 mg 或 17.2 mg 的口服片剂。如需更多信息,请致电 1-800-545-5979 或访问
foundayo.lilly.com
foundayo.lilly.com
.
。
This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it.
本摘要提供有关 Foundayo 的基本信息,但并未包含该药物的所有已知信息。每次配药时,请阅读随处方提供的信息。本信息不能替代与医生的沟通。请务必就 Foundayo 及其服用方法咨询您的医生或其他医疗保健提供者。
Your doctor is the best person to help you decide if Foundayo is right for you..
您的医生是帮助您决定Foundayo是否适合您的最佳人选。
OG CON BS APR2026
OG CON BS 2026年4月
Foundayo
方达约
™
商标
is a trademark of Eli Lilly and Company.
是礼来公司的商标。
U.S. ZEPBOUND INDICATIONS AND SAFETY SUMMARY WITH WARNINGS
美国ZEPBOUND适应症与安全概要(含警告)
Zepbound
Zepbound
®
®
(ZEHP-bownd) is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with:
(ZEHP-bownd) 是一种处方注射药物,配合低热量饮食和增加体力活动,用于帮助成人:
obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.
肥胖症,或伴有体重相关医学问题的超重成人,以减轻多余体重并维持减重效果。
moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA.
中重度阻塞性睡眠呼吸暂停(OSA)和肥胖,以改善其OSA。
Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any
Zepbound 含有替尔泊肽,不应与其他含替尔泊肽的产品或任何
GLP-1
胰高血糖素样肽-1
receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children.
受体激动剂类药物。目前尚不清楚Zepbound在儿童中的使用是否安全有效。
Warnings -
警告 -
Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.
Zepbound 可能导致甲状腺肿瘤,包括甲状腺癌。请留意可能的症状,如颈部肿块或肿胀、声音嘶哑、吞咽困难或呼吸短促。如果出现任何这些症状,请告知您的医疗保健提供者。
Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
如果您或您的家人曾患有称为甲状腺髓样癌(MTC)的甲状腺癌,请勿使用Zepbound。
Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
如果您患有2型多发性内分泌神经瘤综合征(MEN 2),请勿使用Zepbound。
Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.
如果您曾对替尔泊肽或Zepbound中的任何成分发生严重过敏反应,请勿使用Zepbound。
KwikPen
快笔
®
®
: Do not share your KwikPen with other people, even if the pen needle has been changed.
:请勿与他人共用您的 KwikPen,即使已更换笔针。
You may give other people a serious infection or get a serious infection from them.
你可能会传染给他人严重感染,或从他人那里感染严重疾病。
Zepbound may cause serious side effects, including:
Zepbound 可能导致严重的副作用,包括:
Severe stomach problems
严重的胃部问题
. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
. 已有报告指出,使用 Zepbound 的患者可能出现胃部问题,有时可能较为严重。如果您出现严重或持续不缓解的胃部问题,请告知您的医疗保健提供者。
Dehydration leading to kidney problems.
脱水导致肾脏问题。
Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.
腹泻、恶心和呕吐可能导致体液流失(脱水),进而引发肾脏问题。补充水分对于降低脱水风险至关重要。如果出现持续不缓解的恶心、呕吐或腹泻,请立即告知您的医疗保健提供者。
Gallbladder problems.
胆囊问题。
Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.
部分使用Zepbound的患者出现了胆囊问题。如果您出现胆囊问题的症状,包括上腹部(腹部)疼痛、发热、皮肤或眼睛发黄(黄疸)或陶土色粪便,请立即告知您的医疗保健提供者。
Inflammation of the pancreas (pancreatitis).
胰腺炎(胰腺的炎症)。
Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back.
如果您出现严重且持续不缓解的腹部(腹腔)疼痛,无论是否伴有恶心或呕吐,请立即停用 Zepbound 并马上联系您的医疗保健提供者。您可能会感到疼痛从腹部放射至背部。
Serious allergic reactions.
严重过敏反应。
Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.
如果您出现任何严重过敏反应的症状,包括面部、嘴唇、舌头或喉咙肿胀,呼吸或吞咽困难,严重皮疹或瘙痒,昏厥或头晕,或心跳极快,请立即停用 Zepbound 并寻求医疗帮助。
Low blood sugar (hypoglycemia).
低血糖(低血糖症)。
Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin.
如果您将 Zepbound 与可能导致低血糖的药物(如磺脲类药物或胰岛素)联合使用,您发生低血糖的风险可能会更高。
Signs and symptoms of low blood sugar
低血糖的体征和症状
may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.
可能包括头晕或头昏、出汗、意识模糊或嗜睡、头痛、视力模糊、言语不清、颤抖、心跳加快、焦虑、易怒、情绪变化、饥饿感、虚弱或感到紧张不安。
Changes in vision in patients with type 2 diabetes.
2型糖尿病患者的视力变化。
Tell your healthcare provider if you have changes in vision during treatment with Zepbound.
如果您在使用 Zepbound 治疗期间出现视力变化,请告知您的医疗保健提供者。
Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).
在手术或其他使用麻醉或深度镇静(深度睡眠状态)的操作过程中,食物或液体进入肺部。
Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures.
Zepbound 可能会增加在手术或其他操作过程中食物进入肺部的风险。在安排手术或其他操作之前,请告知所有医疗保健提供者您正在服用 Zepbound。
Common side effects
常见副作用
The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss
Zepbound 最常见的副作用包括恶心、腹泻、呕吐、便秘、胃痛(腹痛)、消化不良、注射部位反应、疲劳感、过敏反应、嗳气和脱发。
,
,
and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.
以及胃灼热。这些并非 Zepbound 所有可能的副作用。如有任何令您困扰或持续不退的副作用,请咨询您的医疗保健提供者。
Tell your doctor if you have any side effects.
如有任何副作用,请告知您的医生。
You can report side effects at 1-800-FDA-1088 or
您可以通过 1-800-FDA-1088 报告副作用,或
www.fda.gov/medwatch
www.fda.gov/medwatch
.
。
Before using Zepbound
使用Zepbound之前
Your healthcare provider should show you how to use Zepbound before you use it for the first time.
在您首次使用 Zepbound 之前,您的医疗保健提供者应向您展示如何正确使用该药物。
Talk to your healthcare provider about low blood sugar and how to manage it. Tell your
与您的医疗保健提供者讨论低血糖问题及其管理方法。告知您的
healthcare provider if you are taking medicines to treat diabetes including an insulin or
如果您正在服用治疗糖尿病的药物(包括胰岛素),请联系医疗保健提供者
sulfonylurea.
磺酰脲类
If you take birth control pills by mouth, talk to your healthcare provider before you use
如果您口服避孕药,请在使用前咨询您的医疗保健提供者
Zepbound. Birth control pills may not work as well while using Zepbound.
Zepbound。在使用Zepbound期间,避孕药的效果可能会降低。
Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound.
您的医疗保健提供者可能会建议您在开始使用Zepbound后的4周内,以及在每次增加Zepbound剂量后的4周内,采用另一种类型的避孕措施。
Review these questions with your healthcare provider:
与您的医疗保健提供者一起审查这些问题:
❑ Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ 您是否有其他疾病,包括胰腺问题,或严重的胃部问题,例如胃排空延迟(胃轻瘫)或食物消化障碍?
❑ Do you take diabetes medicines, such as insulin or sulfonylureas?
❑ 您是否服用糖尿病药物,例如胰岛素或磺酰脲类药物?
❑ Do you have a history of diabetic retinopathy?
❑ 您是否有糖尿病视网膜病变病史?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ 您是否已安排进行需要使用麻醉或深度镇静(深睡眠状态)的手术或其他操作?
❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
❑ 您是否正在服用其他处方药、非处方药、维生素或草本补充剂?
❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound..
❑ 您是否怀孕、计划怀孕、正在哺乳或计划哺乳?Zepbound 可能对您的未出生胎儿造成伤害。如果您在使用 Zepbound 期间怀孕,请告知您的医疗保健提供者。Zepbound 可能进入您的母乳中。您应与医疗保健提供者讨论在使用 Zepbound 期间喂养婴儿的最佳方式。
Pregnancy Exposure Registry:
妊娠暴露登记处:
There is a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may call 1-844-524-0039 or email at .
有一个针对在怀孕期间使用过Zepbound的女性的妊娠暴露登记处。该登记处的目的是收集关于您和宝宝健康的信息。请与您的医疗保健提供者讨论如何参与此登记处,或者您可以拨打1-844-524-0039或通过电子邮件联系。
[email protected]
[email protected]
or visit
或访问
https://pregnancyregistry.lilly.com/zepbound
https://pregnancyregistry.lilly.com/zepbound
.
。
How to take
如何服用
Read the Instructions for Use that come with Zepbound.
阅读随 Zepbound 附带的说明书。
Use Zepbound exactly as your healthcare provider says.
请严格按照您的医疗保健提供者的指示使用 Zepbound。
Use Zepbound with a reduced-calorie diet and increased physical activity.
使用 Zepbound 时应配合低热量饮食和增加体力活动。
Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or
将 Zepbound 注射于腹部、大腿或
have another person inject in the back of the upper arm.
让另一个人注射到上臂后侧。
Do not
不要
inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously).
将ZEPBOUND注射到肌肉(肌内注射)或静脉(静脉注射)。
Use Zepbound 1 time each week, at any time of the day.
每周使用一次 Zepbound,一天中的任何时间均可。
Change (rotate) your injection site with each weekly injection.
每次每周注射时更换(轮换)注射部位。
Do not
不要
use the same site for each injection.
每次注射都使用同一个部位。
If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
如果您服用了过量的 Zepbound,请立即联系您的医疗保健提供者、拨打中毒求助热线 1-800-222-1222,或前往最近的医院急诊室。
Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection.
Zepbound 获批的注射剂规格为 2.5 mg、5 mg、7.5 mg、10 mg、12.5 mg 和 15 mg。
Learn more
了解更多
Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to
Zepbound 是一种处方药。如需更多信息,请致电 1-800-LillyRx(1-800-545-5979)或访问
www.zepbound.lilly.com
www.zepbound.lilly.com
.
。
This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it.
本摘要提供有关 Zepbound 的基本信息,但并未包含该药物的所有已知信息。每次配药时,请阅读随处方提供的药品说明书。本信息不能替代与您的医疗保健提供者的沟通。请务必就 Zepbound 及其服用方法与您的医疗保健提供者进行咨询。
Your healthcare provider is the best person to help you decide if Zepbound is right for you..
您的医疗保健提供者是帮助您决定 Zepbound 是否适合您的最佳人选。
ZP CON BS 01SEP2026
ZP CON BS 2026年9月1日
Zepbound
泽邦德
®
®
, its delivery device base and KwikPen
,其给药装置底座和KwikPen
®
®
are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
是礼来公司及其子公司或关联公司拥有或许可的注册商标。
About Lilly
关于礼来
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 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.
礼来是一家将科学转化为疗愈力量、致力于改善全球人民生活的医药公司。150年来,我们始终引领着改变生命的医学发现,如今我们的药物惠及全球数千万患者。凭借生物技术、化学和基因医学的力量,我们的科学家正紧迫地推进新发现,以应对全球最重大的健康挑战:重新定义糖尿病护理;治疗肥胖并遏制其最具破坏性的长期影响;推进阿尔茨海默病的防治工作;为一些最严重的免疫系统疾病提供解决方案;并将最难治疗的癌症转化为可管理的慢性疾病。
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 .
每向更健康的世界迈进一步,我们都由一个信念所驱动:让数百万人的生活变得更加美好。这包括开展反映世界多样性的创新临床试验,并致力于确保我们的药物可及且负担得起。欲了解更多信息,请访问。
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Cautionary Statement Regarding Forward-Looking Statements
关于前瞻性陈述的警示性声明
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Foundayo (orforglipron) as a potential treatment for adults with type 2 diabetes 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.
本新闻稿包含有关Foundayo(orforglipron)作为成人2型糖尿病潜在疗法的预测性陈述(该术语定义见1995年《私人证券诉讼改革法》),并反映了礼来公司当前的信念和预期。然而,与任何药物产品一样,在药物研究、开发和商业化过程中存在重大风险和不确定性。
Among other things, there is no guarantee that planned or ongoing studies will be completed as planned or that future study results will be consistent with study results to date, that Foundayo will prove to be a safe and effective treatment for adults with type 2 diabetes or other potential indications, that Foundayo will receive additional regulatory approvals, or that Lilly will execute its strategy as expected.
除其他事项外,无法保证计划中或正在进行的研究将按计划完成,也无法保证未来的研究结果将与迄今为止的研究结果一致;无法保证Foundayo将被证明是治疗成人2型糖尿病或其他潜在适应证的安全有效疗法;无法保证Foundayo将获得额外的监管批准;也无法保证礼来公司将按预期执行其战略。
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..
有关可能导致实际结果与礼来公司预期存在差异的上述及其他风险和不确定性的进一步讨论,请参阅礼来公司向美国证券交易委员会提交的10-K表和10-Q表文件。除法律要求外,礼来公司不承担更新前瞻性陈述以反映本新闻稿发布日后发生的事件的义务。
Trademarks and Trade Names
商标与商号
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 referenced 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 .
本新闻稿中提及的所有商标或商号均为本公司财产;若本新闻稿中提及属于其他公司的商标或商号,则其为各自所有者的财产。仅为方便起见,本新闻稿中提及的商标和商号均未加注标识。
®
®
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. .
及™符号,但此类引用不应被解释为公司或(在适用范围内)其各自权利人不会依据适用法律在其最大范围内主张相关权利的指示。我们无意通过使用或展示其他公司的商标和商号来暗示我们与任何其他公司存在关联,或获得任何其他公司的认可或赞助。
Refer to:
参见:
Niki Biro;
尼基·比罗;
niki
妮基
[email protected]
[email protected]
(Media)
(媒体)
Michael Czapar;
迈克尔·查帕尔;
czapar
czapar
[email protected]
[email protected]
(Investors)
(投资者)
SOURCE Eli Lilly and Company
来源:礼来公司
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