The goal of this pilot clinical trial is to determine the effectiveness of Tirzepatide in patients with persistent obesity (BMI > 30) 12 months after bariatric surgery (Roux-en-Y Gastric Bypass). The investigators also aim to determine the frequency of side effects with Tirzepatide in this patient population. Patients who take tirzepatide 12 months after bariatric surgery will be compared to patients who receive a placebo.

开始日期2024-10-01

申办/合作机构

Vanderbilt University Medical Center

NCT06073184 / Not yet recruiting临床2期

Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium (WE-FiERCE)

The incidence of endometrial cancer is increasing at an alarming rate. This trend parallels the rising rate of obesity, the most significant risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility are treated with progestin therapy, such as progestin intra-uterine device (pIUD), which is associated with a mediocre response rate and high recurrence rate, and does not address the underlying cause, obesity. Therefore, the investigators want to assess whether the addition of a weight-loss drug to pIUD will improve their oncologic, reproductive and metabolic outcomes.

开始日期2024-09-01

申办/合作机构

University Health Network

NCT06246799 / Not yet recruiting临床3期IIT

Comparative Effectiveness of Two Initial Combination Therapies in Patients With New Onset Diabetes

The goal of this randomized, open labelled clinical trial is to examine the efficacy, durability, and mechanism of HbA1c reduction produced by the combination of pioglitazone plus tirzepatide versus metformin plus sitagliptin in recently diagnosed type 2 diabetes mellitus patients.
The main question[s] it aims to answer are:
How effective is the combination of pioglitazone plus tirzepatide in managing blood sugar levels in people with type 2 diabetes? How does this combination compare to the use of metformin plus sitagliptin in controlling blood sugar levels? Participants will receive Pioglitazone beginning at 15 mg daily and ending 45 mg daily. (15mg month 1, 30mg month 2 and 45mg at month 3 onwards)

开始日期2024-07-01

申办/合作机构

University of Texas Health Science Center At San Antonio

[+1]

100 项与替尔泊肽相关的临床结果

登录后查看更多信息

100 项与替尔泊肽相关的转化医学

登录后查看更多信息

100 项与替尔泊肽相关的专利（医药）

登录后查看更多信息

331

项与替尔泊肽相关的文献（医药）

2024-04-01·The Annals of pharmacotherapy

Incretin Analogs for Weight Management in Adults Without Diabetes

Review

作者: Lobkovich, Alison ; Lipari, Melissa ; Kale-Pradhan, Pramodini

Objective::

This is a narrative review of incretin analogs and their effect on weight management in adult without diabetes.

Data Sources::

Randomized controlled trials were identified by English language. PubMed/MEDLINE, Scopus, and Embase databases were searched from inception through June 2023 to identify all pertinent trials reporting outcomes on efficacy and safety search using the terms: tirzepatide, semaglutide, liraglutide, and obesity.

Study Selection and Data Extraction::

Selected studies were included if the study population was composed of adults without diabetes being treated by glucagon-like peptide 1 (GLP-1) receptor agonists or glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 agonists for weight management, and weight loss was assessed as a primary outcome.

Data Synthesis::

Fifteen studies involving 3 pharmacotherapies (liraglutide, semaglutide, and tirzepatide) were identified. Efficacy data supporting the use of these agents for weight management were promising when compared to placebo and/or other behavioral therapies. Percent weight loss ranged from 5.7% to 11.8%, 14.9% to 17.4%, and 15% to 20.9% for liraglutide, semaglutide, and tirzepatide, respectively. Safety data were relatively similar across all trials and identified gastrointestinal adverse effects as most common.

Relevance to Patient Care and Clinical Practice::

Glucagon-like peptide 1 agonists are preferred for overweight or obese patients by the American Gastroenterological Association. Future guidelines may address tirzepatides’ place in therapy as new evidence comes forth. Providers should consider patient-specific factors such as cost, adverse effects, drug interactions, and comorbidities when prescribing these agents and provide education regarding the need for concurrent diet and exercise modifications.

Conclusions::

All incretin analogs in this review are superior to placebo when used for weight management in adults without diabetes.

2024-03-01·Peptides

Recent advances in peptide-based therapies for obesity and type 2 diabetes

Article

作者: Flatt, Peter R ; Conlon, J Michael ; Bailey, Clifford J

Options for the treatment of type 2 diabetes mellitus (T2DM) and obesity have recently been expanded by the results of several large clinical trials with incretin-based peptide therapies. Most of these studies have been conducted with the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide, which is available as a once weekly subcutaneous injection and once daily tablet, and the once weekly injected dual agonist tirzepatide, which interacts with receptors for GLP-1 and glucose-dependent insulinotropic polypeptide (GIP). In individuals with T2DM these therapies have achieved reductions of glycated haemoglobin (HbA1c) by > 2% and lowered body weight by > 10%. In some studies, these agents tested in non-diabetic, obese individuals at much higher doses have lowered body weight by > 15%. Emerging evidence suggests these agents can also offer cardio-protective and potentially reno-protective effects. Other incretin-based peptide therapies in early clinical development, notably a triple GLP-1/GIP/glucagon receptor agonist (retatrutide) and a combination of semaglutide with the amylin analogue cagrilintide (CagriSema), have shown strong efficacy. Although incretin therapies can incur adverse gastrointestinal effects these are for most patients mild-to-moderate and transient but result in cessation of treatment in some cases. Thus, the efficacy of new incretin-based peptide therapies is enhancing the opportunity to control body weight and blood glucose and improve the treatment of T2DM and obesity.

2024-03-01·European journal of internal medicine

Effect of tirzepatide on blood pressure levels in overweight/obese individuals without diabetes

Letter

作者: Patoulias, Dimitrios ; Popovic, Djordje S ; Koufakis, Theocharis ; Doumas, Michael ; Stavropoulos, Konstantinos

Meta-anal. of effect of tirzepatide on blood pressure levels in overweight/obese individuals without diabetes.Tirzepatide is a novel dual gastric inhibitory polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor co-agonist recently approved for the treatment of type 2 diabetes (T2D) and obesity.Tirzepatide therapy leads to a decrease in BP levels through both direct and indirect mechanisms.Herein, we performed the first relevant meta-anal. of published RCTs, aiming to provide pooled effect estimates regarding the effect of tirzepatide therapy on BP levels among overweight/obese individuals without T2D.We searched PubMed and Cochrane Library databases from inception to 14th Dec. 2023 for phase 2/3 RCTs enrolling overweight/obese adult subjects without T2D at baseline, randomized either to tirzepatide (any dose) or control (placebo or active comparator).Approx. one-third of enrolled participants had baseline hypertension and SBP and DBP levels across all eligible RCTs were within normal range.Subjects treated with tirzepatide (all doses) vs. placebo experienced a significant reduction in both SBP by 7.3 mm Hg (MD = -7.30, 95% CI;- 9.01 to -5.60, I2 = 71%, p < 0.001) and DBP by 4.35 mm Hg (MD = - 4.35, 95% CI; -5.29 to -3.41, I2 = 49%, p < 0.001).Overall risk of bias was low for all eligible RCTs included in this anal.In conclusion, preliminary evidence suggests that tirzepatide might produce a significant, beneficial effect on BP levels in overweight/obese subjects without T2D at baseline.

1,740

项与替尔泊肽相关的新闻（医药）

2024-07-01

·PRNewswire

Introducing SHOWW, the Only Telemedicine Company in the Industry Offering a FDA-Regulated 503B Pharmacy Compounded Semaglutide

MIAMI, July 1, 2024 /PRNewswire/ -- Companies can tell their prospective customers anything, but a recently launched business prefers guaranteed results. SHOWW is a weight loss telemedicine brand offering compounded semaglutide, which is the active ingredient in medications like Wegovy® and Ozempic®. SHOWW sets itself apart from other similar companies in the industry with its ultra-high quality FDA-Regulated 503B Pharmacy Compounded Semaglutide. Continue Reading SHOWW your best self. Semaglutide is an injectable medication initially prescribed as a diabetes treatment. The United States Food and Drug Administration approved it as a medical treatment for weight loss in 2021, and it has taken the world by storm since then. Recent research from the University of California, Los Angeles, shows semaglutide can be an effective way to help support weight loss by curbing appetite while reducing the risk of cancer, diabetes, and heart disease in overweight people. Weight loss medications featuring semaglutide have been prominent in the medical community in recent years, but not all providers are the same. Many brand-name semaglutide products can cost over $1,200 monthly. At SHOWW, customers enjoy the same level of quality and safety for a quarter of the price. The company uses clear pricing and transparent processes, with no hidden fees or manipulative tactics. Standing Out in the Crowd Telemedicine is an emerging industry, and many people may not know how simple it can be to speak with a doctor, get a prescription, and order recurring medication delivery from the comfort of home. At SHOWW, there are no appointments or wait times, and clients can receive their semaglutide in as little as four days. SHOWW is the only semaglutide provider that employs a team of licensed doctors specializing in weight loss exclusively to prescribe medication and monitor patients' progress. These physicians do not offer any other services outside personalized weight loss solutions. The in-house team ensures clients aren't forced to endure long wait times to receive a prescription and treatment while preventing crossed wires or communication delays. Safe and Reliable Solutions As the usage of semaglutide grows, it becomes increasingly important for consumers to ensure they receive safe, accurate prescription medications. With SHOWW, clients experience premium telemedicine solutions and a reliable, personalized approach to their healthcare. SHOWW's products are manufactured in a $250 million 503B compounding pharmacy. Unlike 503A facilities, every process at SHOWW must be validated. All medications are submitted for testing prior to being released for sale, ensuring every prescription leaving the facility is of consistent quality and meets all regulatory guidelines. This testing allows 503B compounding pharmacies to guarantee they produce the highest-quality products fit for use in doctor's offices, clinics, and hospitals. The popularity of semaglutide as a weight loss medication has been so widespread that many areas have experienced shortages. SHOWW's 503B compounding pharmacy manufactures its products independently, so its productivity isn't dependent on external supply chains, and customers will not experience shortages. Delivering Guaranteed Results The internet is rife with scam companies out to take a customer's money without making a timely delivery of the product as described. SHOWW works to offer clients as much transparency, security, and convenience as possible while reliably delivering high-quality medication. Clients enjoy fast, free shipping at SHOWW. All orders ship within 24 hours through FedEx or a two-day UPS courier, which means customers receive their medication less than four days after ordering it. Unlike many online providers, SHOWW always has semaglutide in stock, and customers never have to worry about inconvenient delays or issues refilling their medication. According to a litany of customer complaints filed with the Better Business Bureau, many telemedicine providers rely on automated customer support. By contrast, SHOWW offers its clients 24/7 assistance via phone, email, SMS, or live chat. The customer's experience and satisfaction are a priority for SHOWW, and it works to ensure clients can always find answers to their questions. The team is entirely based in the United States, and live representatives are available from 9 a.m. to 6 p.m. EDT daily. All inquiries are answered within 24 hours. Medicine-Assisted Weight Management in Four Steps Getting started with SHOWW is a simple process. Start by completing an online application. In five minutes, clients learn whether SHOWW can help support their weight loss goals. If they are a good match, a licensed doctor will review their information and decide whether semaglutide is an appropriate treatment. "Online consultations at SHOWW are typically free," representatives said. "You'll only pay for the prescription if you qualify after your medical consultation." Once a doctor prescribes the medication, the order is passed on to SHOWW's 503B compounding pharmacy partner and delivered in under four days. As treatments continue, patients monitor their progress and measure it against their goals during monthly doctor check-ins. "We aim to ensure every patient understands their treatment and achieves the best results," SHOWW founders said. "Our support team and physicians are available for free, unlimited follow-ups." In addition to semaglutide, SHOWW offers GLP-1 medications like tirzepatide, which is the active ingredient in similar products like Zepbound™ and Mounjaro®. The company's team of qualified weight loss specialists will determine the most appropriate medications for an individual client's treatment goals, which may include additional drugs like metformin. Semaglutide prescription is not guaranteed for every client and is dependent upon physician approval. Semaglutide treatment is generally not recommended for individuals with a history of medullary thyroid cancer, gallbladder disease, pancreatitis, or multiple endocrine neoplasia syndrome type 2. "Your health journey is unique, and so is our approach to your care," SHOWW founders said. "Rest assured, your treatment plan will be as unique as you are." Affordable and Accessible While SHOWW does not currently accept insurance coverage for its services, the products it provides can often be less expensive than many co-payments. Offering free virtual consultations further reduces the costs and makes medication-assisted weight loss affordable and accessible to ideal candidates. With SHOWW, affordable telemedicine weight loss solutions are available to all qualified patients in the United States. Not only do customers reliably receive their semaglutide medication on time, but they can rest assured that refill prescriptions will also arrive on time and they'll never be left in dark due to shortages or backlogs. Welcome to the SHOWW When it comes to online solutions for weight loss, one telemedicine brand prefers to SHOWW rather than tell. Visit the SHOWW website to learn more about the telemedicine brand or to schedule a free weight loss consultation. It takes less than five minutes to complete the initial online application and discover whether semaglutide might be an appropriate treatment option. Current and prospective customers may also contact SHOWW at (888) 413-7469 or email [email protected]. The brand maintains an online presence on Facebook and Instagram for those who wish to contact SHOWW for social media purposes. SOURCE SHOWW LLC

上市批准

2024-07-01

·药精通Bio

-16.8%，-18.6%，-14.37%！恒瑞、甘李、信达GLP-1类药物减重数据亮相2024ADA

深度聚焦多肽、多肽偶联药物研发、质控、工艺开发，展位咨询&免费入场券：联系电话181 1603 6798，扫码立即获取免费入场券：在2024年美国糖尿病协会科学（ADA）年会上，恒瑞医药、甘李药业、信达生物等企业分别展示了其GLP-1类药物的减重数据：恒瑞医药：首次披露了其自主研发的GLP-1/GIP双受体激动剂HRS9531最新II期研究结果，治疗24周后，HRS9531注射液1.0 mg、3.0 mg、4.5 mg和6.0 mg剂量组体重自基线分别下降5.4%、13.4%、14.0%、16.8%，而安慰剂组仅下降0.1%。甘李药业：披露了其GLP-1受体激动剂GZR18的Ib/IIa期临床研究结果，治疗35周后，GZR18 QW组体重与安慰剂组的差值达-18.6%。与已上市产品的减重数据相比（间接对比），在相似给药周期中的减重效果优于司美格鲁肽和替尔泊肽。信达生物：玛仕度肽的减重III期GLORY-1研究结果显示，治疗32周后，相比安慰剂组，玛仕度肽4 mg、6 mg剂量组分别减重10.72%、13.14%。且玛仕度肽9 mg高剂量II期临床的最新数据显示，治疗24周后实现减重15.4%。这些国产GLP-1类药物的研究数据展示了非常优秀的减重效果，国产GLP-1的时代要来临了。 01 恒瑞医药：治疗24周后，GLP-1/GIP双靶点激动剂HRS9531体重降幅达16.8% 在2024年ADA年会上，恒瑞医药首次披露了其自主研发的GLP-1/GIP双受体激动剂HRS9531的最新临床II期数据，HRS9531显著降低肥胖患者的体重，并改善腰围、血压、甘油三酯、血糖和胰岛素抵抗等代谢指标，耐受性良好。该研究是一项随机、双盲、安慰剂对照的II期研究（NCT05881837），纳入年龄在18~65岁、体重指数（BMI）为28~40 kg/m2的中国肥胖成年人，且受试者需要在最近3个月内体重变化小于5 kg，将受试者按照1:1:1:1:1的比例随机分配到HRS9531注射液1.0毫克、3.0毫克、4.5毫克和6.0毫克或安慰剂组，持续治疗24周，每周一次皮下注射HRS9531。主要治疗终点是24周时体重较基线的变化。该研究共纳入249名受试者，其中约97%（240）的患者完成了24周的双盲治疗期，总体人群中患者平均体重为91.5 kg。治疗24周后，HRS9531各剂量组的体重较基线显著降低，1.0毫克、3.0毫克、4.5毫克和6.0毫克剂量组的参与者体重分别减轻5.4%、13.4%、14.0%和16.8%，而安慰剂组仅减轻0.1%。另外，HRS9531 各组随着治疗时间延长体重持续下降，基本呈剂量依赖性，6.0毫克剂量组减重效果最为显著。在次要治疗终点方面，在4个剂量组中，治疗24周后体重较基线减轻≥5%的参与者比例分别为52.0%、88.2%、92.0%、91.8%，安慰剂组为10.2%。此外，HRS9531组的腰围和收缩压较基线下降12.7 cm和8.3 mmHg，安慰剂组仅下降1.8 cm和0.4 mmHg。HRS9531也改善了血糖、甘油三酯（TG）、谷丙转氨酶（ALT）、尿酸等指标，优于安慰剂。安全性方面，大多数不良事件（AEs）为轻度或中度，最常见的不良事件为恶心、腹泻、食欲下降和呕吐，主要发生在剂量递增期间。HRS9531的总体安全性和耐受性与其他GLP-1激动剂一致。 HRS9531是恒瑞医药自主研发的新型GLP-1和GIP双重受体激动剂，可通过同时激动GLP-1和GIP受体，发挥葡萄糖依赖性的促胰岛素分泌、抑制食欲和改善胰岛素敏感性等作用，帮助降低血糖和减轻体重。目前该药物最高研发阶段在临床III期（肥胖），HRS9531有效降低体重、血压、血糖和甘油三酯，具有良好的安全性。这些数据支持HRS9531用于肥胖治疗的进一步临床开发。在HRS9531注射液的基础上，恒瑞医药进一步开发其口服制剂，期望能改善GLP-1类产品的给药便利性、提高患者依从性和接受度。2024年5月，口服HRS9531片开展用于2型糖尿病和体重管理的临床试验收到国家药品监督管理局核准签发的《药品临床试验批准通知书》。目前全球范围内尚无口服同类产品上市。 02 甘李药业：GLP-1RA GZR18注射液35周减重16.5kg，且可实现两周给药一次在2024年ADA年会上，甘李药业披露了其自主研发的GLP-1受体激动剂GZR18在中国肥胖患者中Ib/IIa期临床研究结果。研究结果提示，一周一次的GZR18给药可实现优异的减重效果，疗效与同类单靶点或者多靶点GLP-1受体激动剂可比（非头对头）。GZR18两周给药也显示了优异的疗效。该研究是一项在中国肥胖/超重患者中开展的随机、双盲、安慰剂对照的多次剂量递增研究，该研究主要评估受试者接受每周（QW）或每两周（Q2W）一次GZR18注射液治疗后的安全性、耐受性、药代动力学和有效性。该研究总共入组36名肥胖受试者，按3:1的比例随机接受1.5毫克至30毫克的GZR18注射液或安慰剂组治疗，总治疗周数35周。研究显示，治疗35周后，GZR18注射液每周组体重较基线平均降低16.6kg（95%CI：-19.9 kg, -13.1 kg），体重与安慰剂组的差值达-18.6%（95%CI：-25.5%, -11.6%）。与已上市同类产品相比（非头对头），GZR18在相似给药周期中的减重效果优于司美格鲁肽和双靶点的替尔泊肽。此外，GZR18注射液每两周组体重较基线平均降低11.3kg（95%CI：-15.4 kg, -7.2 kg），与安慰剂组的平均变化差值达-13.5%（95%CI：-21.0%, -6.0%）。在次要终点方面，GZR18注射液每周组体重较基线降低≥5%、10%、15%的受试者比例分别为100.0%、90.0%和80.0%，这一数字在每两周组分别为71.4%、71.4%和42.9%。安全性方面，GZR18注射液显示出良好的耐受性，治疗期间最常见的不良事件为胃肠道相关不良事件，且全部为轻、中度。 GZR18是甘李药业自主开发的一款GLP-1受体激动剂，拟用于成年患者的 2 型糖尿病的治疗或肥胖/超重患者的体重管理，临床前数据表明 GZR18 具有降糖和减轻体重的潜力，已完成的部分临床研究证实 GZR18 在人体内具有出色的降糖和减重效果，同时安全性特征良好。目前该药物的最高研发阶段在临床II期。在GZR18注射液的基础上，甘李药业开发了其口服剂型，GZR18片采用了先进的口服化给药技术，促进药物在胃内的吸收，通过抵抗胃蛋白酶降解，从而延长药物半衰期，提高GZR18片的生物利用度。2024年4月，GZR18片完成适应症为2型糖尿病的一项中国I期临床试验的首例受试者给药。 03 信达生物：玛仕度肽6 mg组治疗48周后减重14.37% 在2024年ADA大会上，信达生物公布了其GLP-1R/GCGR双重激动剂玛仕度肽的临床结果，结果包括减重III期注册临床GLORY-1研究、玛仕度肽9 mg高剂量减重II期临床研究。 GLORY-1研究是一项随机、双盲、安慰剂对照III期试验，旨在评估每周一次的玛仕度肽用于中国超重或肥胖受试者的有效性和安全性。该研究纳入610例受试者，按1:1:1的比例随机分配至玛仕度肽 4 mg组、玛仕度肽 6 mg组或安慰剂组，共治疗48周。主要终点是第32周时受试者体重相对基线的百分比变化以及体重相对基线下降≥5%的受试者比例。研究结果显示，治疗32周后，相比安慰剂组，玛仕度肽4 mg、6 mg剂量组分别减重10.72%、13.14%。关键次要终点，治疗48周减重百分比，4 mg剂量组减重11.58%，6 mg剂量组减重14.37%。同时，玛仕度肽治疗48周后参与者心血管风险参数也都显著降低。相比于安慰剂组，玛仕度肽治疗组血压降低6.75 mmHg，甘油三酯降低0.52 mmol/L，总胆固醇降低0.45 mmol/L，LDL-C降低0.31 mmol/L，血尿酸降低50.75 mmol/L，ALT降低10 U/L。安全性方面，玛仕度肽整体耐受性良好，4 mg、6 mg剂量组的停止治疗比例分别为1.5%、0.5%，安慰剂组这一比例为1.0%。最常报告的不良事件是胃肠道不良事件，严重程度大多为轻度至中度。信达生物还公布了玛仕度肽9mg高剂量II期临床的最新数据，治疗24周减重15.4%，肝脏脂肪减少73.3%。玛仕度肽9 mg显示出强大的体重减轻和显著的肝脏益处。此前，根据信达生物公布的玛仕度肽高剂量9 mg在中国肥胖受试者中的II期临床研究结果，治疗48周后，玛仕度肽9 mg组体重较基线的平均百分比变化与安慰剂组的治疗差值达-18.6%，平均变化值与安慰剂组的差值达-17.8 kg 04 全球用于减重的GLP-1类在研药物 GLP-1赛道非常“内卷”，放眼全球，临床II期及以上拟用于减重的GLP-1管线数量超过40个。替尔泊肽：SURMOUNT-CN研究是一项随机、双盲、安慰剂对照的III期临床试验，纳入了体重指数（BMI）≥28 kg/m2，或BMI≥24 kg/m2但至少有1种体重相关合并症（不包括糖尿病）的210名中国成年人。将受试者按照1:1:1随机分为3组，分别接受每周一次皮下注射给药10 mg替尔泊肽（n=70）、15 mg替尔泊肽（n=71）和安慰剂（n=69），治疗52周。研究结果显示，第52周，接受替尔泊肽10 mg和15 mg治疗的受试者体重平均下降百分比分别为-13.6%（12.3 kg）和-17.5%（16.1 kg），而安慰剂组仅为-2.3%。替尔泊肽10 mg组和15 mg组分别有87.7%和85.8%的受试者实现体重减轻≥5%，而安慰剂组仅为29.3%。司美格鲁肽：OASIS 1研究是一项全球IIIa期研究，为期68周，旨在评估司美格鲁肽的疗效及安全性。研究共纳入667名超重/肥胖且患有一种或多种合并症的成年患者，给予其每日一次口服司美格鲁肽50 mg来进行体重管理。经过68周的治疗：口服司美格鲁肽50 mg组在68周后体重减轻了17.4%（18.34kg），而安慰剂组体重减轻了 1.8%（1.9kg）。此外，司美格鲁肽组中有89.2%的患者在68周后体重减轻了≥5%（5.27kg），而安慰剂组中这一比例约为24.5%。另外，银诺医药、华东医药、博瑞医药等国内企业正在积极推进GLP-1产品治疗减肥胖的研发进度。除恒瑞、甘李及信达外，还有博瑞医药、翰森制药、先为达生物在今年美国糖尿病学会(ADA)学术会议公布了GLP-1类药物肥胖患者临床治疗2周至4周的减重数据，期待这些药物拉长时间维度的临床进展。全球临床II期及以上GLP-1减重管线，截止2024年6月资料来源：恒瑞医药官媒、甘李药业官媒、国际糖尿病idiabetes END 免责声明：本文信息来源于网络，本文仅作知识交流与分享及科普目的，不涉及商业宣传，不作为相关医疗指导或用药建议。文章如有侵权请联系删除。深度聚焦多肽、多肽偶联药物研发、质控、工艺开发，7月相约苏州，联系电话18116036798上下滑动查看议程戳“阅读原文”立即报名多肽药物论坛吧!

临床2期临床3期临床结果临床成功

2024-06-30

·药融圈

道尔生物方永亮：创新型靶向GLP-1R/GIPR的双靶点激动剂的发现和临床转化

创新型靶向GLP-1R/GIPR的双靶点激动剂是一种药物，它同时激活胰高血糖素样肽-1受体（GLP-1R）和葡萄糖依赖性促胰岛素多肽受体（GIPR），这两种受体在调节人体血糖平衡中起着重要作用。这种药物的开发旨在通过双重激动作用，实现更好的疗效，例如在治疗2型糖尿病和肥胖症方面。根据药融云数据，替尔泊肽（Tirzepatide）是已经获批上市的GLP-1R/GIPR双重激动剂之一，由礼来公司研发，用于成人2型糖尿病的治疗，并在减重方面也显示出潜力。此外，还有其他一些药物如INCB-106385等正在临床试验阶段（见图1）。这类激动剂的开发是医药领域的一个创新方向，旨在提供更有效的治疗方案。想了解道尔创新型靶向GLP-1R/GIPR的双靶点激动剂的发现和临床转化，欢迎来2024生物医药创新博览会现场，听方永亮博士分享。立即扫码报名参会↓↓ 嘉宾简介浙江道尔生物科技有限公司，首席运营官方永亮博士将出席GLP-1及多肽药物开发论坛，发表主题演讲：创新型靶向GLP-1R/GIPR的双靶点激动剂的发现和临床转化简介：方永亮博士本科毕业于中国药科大学，之后于美国达特茅斯学院（Dartmouth College）获得博士学位。主要研究方向为蛋白工程、免疫原性分析、蛋白降低免疫原性的改造、药物发现和临床转化。曾作为美国Occulo公司的共同创始人和首席运营官，主导了Occulo公司A轮融资，管线开发，关键资产的授权和项目对外许可等。现担任浙江道尔生物科技有限公司首席运营官，主要负责道尔生物的创新药注册、临床转化和运营、商务拓展等工作。立即扫码报名参会↓↓ 同时，小编整理了前沿新药文献资料汇总，可供查阅，累计70篇，欢迎报名后加V：13375768723领取。扫码报名，获取门票峰会日程 9:00-9:20 甘李药业 GLP-1 受体激动剂陈伟，甘李药业，副总经理 9:20-9:40 众生睿创基于 GLP-1RAS 在代谢领域差异化布局和创新陈小新，众生睿创，CEO 9:40-10:00 创新型靶向 GLP-1R/GIPR 的双靶点激动剂的发现和临床转化方永亮，道尔生物，COO 10:00-10:20 降糖领域中多肽药物的开发策略及全球趋势姜帆，银诺医药，副总裁 10:20-10:40 多肽药物的质量控制策略健元医药 10:40-11:00 GLP-1，除了减重，还能卷什么？左亚军，仁会生物，总经理 11:00-11:20 多肽特色管线布局与研发策略孟广鹏，成都诺和晟泰，创新药总监 11:20-12:00 圆桌对话：多肽类创新药物的发展方向？方永亮，道尔生物，COO 伟，甘李药业，副总经理小新，众生睿创，CEO 汉栋，九源基因，副总经理 12:00-13:30 午餐 13:30-13:50 抗感染新药管线布局及研发趋势 13:50-14:10 硕迪生物口服小分子 GLP-1 受体激动剂林熹晨，硕迪生物，首席科学官兼总裁 14:10-14:30 化学合成多肽药物的 CMC 研究 14:30-14:50 基于 240 万实体多肽分子库的高通量筛选及多肽芯片筛选项目案例高剑，禾泰健宇，董事长 14:50-15:10 多肽药物的药效学研究 15:10-15:30 全球首款多肽偶联骨再生靶向创新药莱博瑞辰 15:30-15:50 环肽创新药的发现：从长效棘白菌素到口服 PCSK9 抑制剂原晨光，祥根生物，联合创始人&CSO 15:50-16:10 多肽类药物在临床期间的 CMC 研究的多变性苑字飞，甘李药业，副总经理，首席技术官 16:10-16:30 GLP1 新药的动物模型选择及评价同期会议>> 参会报名参展人员生物医药行业一、二级市场的投资机构化学&生物制药企业董事长、总经理等管理层；制药企业研发总监、经理、研究员等研发人员；研发机构、原料药中间体生产企业负责人等；药学研发机构负责人等；临床试验机构负责人等； MAH B证企业；商务（市场、销售、BD）负责人；投资机构相关人员；药物安全性评价机构、药物研发咨询机构、医药科研院所、药检单位和医药高等院校中从事药物研究的相关人员...........等全产业链行业相关人士！商务合作大会开放各类专属支持方案及超350个现场展位，可为生物药/化学药相关新药/仿制药药学研发机构CRO/CDMO等企业提供展位、演讲、联合主办、晚宴冠名、项目路演、卫星会、明星打造等多形式的宣传展示。展位优惠活动即将截止！详情咨询主办方： CMC博览会福利官 15301612029

申请上市

100 项与替尔泊肽相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11360	-	-	DB15171

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
肥胖	美国	Eli Lilly & Co.	2023-11-08
超重	美国	Eli Lilly & Co.	2023-11-08
2型糖尿病	美国	Eli Lilly & Co.	2022-05-13

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
阻塞性睡眠呼吸暂停综合征	申请上市	美国	Eli Lilly & Co.	2024-06-21
体重增加	临床3期	美国	Eli Lilly & Co.	2024-06-01
体重增加	临床3期	阿根廷	Eli Lilly & Co.	2024-06-01
体重增加	临床3期	澳大利亚	Eli Lilly & Co.	2024-06-01
体重增加	临床3期	加拿大	Eli Lilly & Co.	2024-06-01
体重增加	临床3期	法国	Eli Lilly & Co.	2024-06-01
体重增加	临床3期	德国	Eli Lilly & Co.	2024-06-01
体重增加	临床3期	以色列	Eli Lilly & Co.	2024-06-01
体重增加	临床3期	墨西哥	Eli Lilly & Co.	2024-06-01
体重增加	临床3期	波多黎各	Eli Lilly & Co.	2024-06-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04657003 (SURMOUNT-2, ADA2024) 人工标引	临床3期	2型糖尿病 \| 肥胖	-	Tirzepatide	餘糧襯襯簾鏇鏇遞鹹廠(構築網艱襯遞壓艱築鏇) = 鬱廠襯繭選遞構鹽築積製鬱醖選選鹽襯築餘襯 (築鹹鬱廠夢衊顧鑰壓願 )	积极	2024-06-21
				Placebo	-
NCT04166773 (SYNERGY-NASH, Biospace \| EASL2024) 人工标引	临床2期	非酒精性脂肪性肝炎	157	Tirzepatide 5mg	憲構顧遞選衊願網膚襯(襯鹹廠餘廠顧齋鏇遞糧) = 壓簾壓選廠襯壓醖鬱衊夢艱選鹽鹽鏇鹹繭築窪 (觸積繭衊顧鏇鬱簾鹹夢 ) 更多	积极	2024-06-05
				Tirzepatide 10mg	憲構顧遞選衊願網膚襯(襯鹹廠餘廠顧齋鏇遞糧) = 選憲夢遞積獵鏇醖艱鬱夢艱選鹽鹽鏇鹹繭築窪 (觸積繭衊顧鏇鬱簾鹹夢 ) 更多
NCT04660643 (SURMOUNT-4, CTgov)	临床3期	2型糖尿病 \| 肥胖	783	Placebo (Placebo)	醖壓鹽衊襯鹹衊醖製膚(糧觸範築鏇窪獵廠構簾) = 簾夢範糧獵艱顧襯憲網廠遞壓鏇鏇膚遞獵築蓋 (鑰鑰繭築鹹積獵襯獵壓, 蓋獵繭鬱夢繭淵鹹簾遞 ~ 夢遞窪壓繭窪構範窪廠) 更多	-	2024-05-22
				Tirzepatide (Tirzepatide MTD)	醖壓鹽衊襯鹹衊醖製膚(糧觸範築鏇窪獵廠構簾) = 鬱遞顧積網遞餘簾願夢廠遞壓鏇鏇膚遞獵築蓋 (鑰鑰繭築鹹積獵襯獵壓, 觸積壓簾蓋膚簾繭齋製 ~ 觸蓋選壓襯廠鑰鹽窪顧) 更多
NCT04311411 (CTgov)	临床1期	肥胖	114	Placebo (Placebo)	壓顧壓願鹹築願糧鏇鏇(鹹艱構構網構簾積簾遞) = 構餘鑰窪範積廠築構醖遞構襯遞壓壓鏇積遞簾 (憲廠積構齋觸齋積選壓, 簾遞窪鹹襯淵蓋鏇蓋範 ~ 繭積衊醖積蓋鑰繭簾範) 更多	-	2024-05-22
				Tirzepatide (Tirzepatide)	壓顧壓願鹹築願糧鏇鏇(鹹艱構構網構簾積簾遞) = 鑰鹹鑰構廠觸觸鑰網簾遞構襯遞壓壓鏇積遞簾 (憲廠積構齋觸齋積選壓, 範繭窪鏇鹹廠膚鹹衊襯 ~ 範鏇鬱糧蓋鏇範願鹹網) 更多
NCT04050553 (CTgov)	临床1期	2型糖尿病 \| 低血糖	42	Placebo	繭餘鹹繭積遞夢積築繭(艱醖選憲艱壓願醖糧蓋) = 廠繭鏇獵襯鹹廠淵顧積窪夢衊壓網醖襯廠襯鬱 (窪鹹觸繭鏇蓋構製淵鑰, 製鏇壓顧艱願獵構遞窪 ~ 襯廠遞齋鏇艱鹹蓋願築) 更多	-	2024-05-20
NCT04657016 (CTgov)	临床3期	肥胖 \| 2型糖尿病	579	Placebo (Placebo)	蓋窪顧糧鬱鹹餘醖鹽壓(蓋範鹽憲衊夢醖蓋鑰艱) = 糧鹹選觸觸觸構選憲淵鑰簾蓋構觸膚餘衊製鹽 (選願鬱積網觸醖顧選艱, 夢襯繭製鏇積遞醖鏇醖 ~ 糧獵餘膚築膚積夢衊鹹) 更多	-	2024-05-16
				Tirzepatide (Tirzepatide)	蓋窪顧糧鬱鹹餘醖鹽壓(蓋範鹽憲衊夢醖蓋鑰艱) = 鏇淵構鏇選窪窪窪鑰艱鑰簾蓋構觸膚餘衊製鹽 (選願鬱積網觸醖顧選艱, 鏇獵繭窪餘製衊糧鹹獵 ~ 積簾壓壓蓋蓋餘膚糧鏇) 更多
NCT05412004 (SURMOUNT-OSA, Corporate Publications) 人工标引	临床3期	阻塞性睡眠呼吸暂停综合征 \| 肥胖	469	Tirzepatide (Participants Not on PAP Therapy)	獵淵蓋範淵廠鑰糧夢繭(構醖構憲鹽夢選齋選構) = 築餘鏇夢繭襯窪餘衊鏇衊憲範餘衊鹽廠選壓製 (夢齋顧鑰蓋鑰鹹鬱糧網 ) 达到更多	积极	2024-04-17
				Tirzepatide (Participants Used PAP Therapy)	獵淵蓋範淵廠鑰糧夢繭(構醖構憲鹽夢選齋選構) = 築範顧糧範構觸遞製積衊憲範餘衊鹽廠選壓製 (夢齋顧鑰蓋鑰鹹鬱糧網 ) 达到更多
NCT04657003 (SURMOUNT-2, CTgov)	临床3期	2型糖尿病 \| 肥胖	938	Placebo (Placebo)	壓廠艱觸網構築鑰淵窪(蓋淵鏇鹹夢齋願糧餘鑰) = 觸願蓋積壓網構獵積夢淵遞網選構夢蓋鑰糧醖 (壓遞醖艱鹽衊遞襯夢膚, 範餘鏇選襯蓋鏇蓋淵憲 ~ 醖簾觸淵鑰遞遞艱鑰鬱) 更多	-	2024-04-08
				Tirzepatide (15 mg Tirzepatide)	壓廠艱觸網構築鑰淵窪(蓋淵鏇鹹夢齋願糧餘鑰) = 築淵壓願鏇積獵蓋醖齋淵遞網選構夢蓋鑰糧醖 (壓遞醖艱鹽衊遞襯夢膚, 鑰蓋簾蓋餘願顧夢夢夢 ~ 蓋鏇簾醖網鏇壓鹹淵遞) 更多
NCT04081337 (CTgov)	临床1期	肥胖	55	Placebo	醖齋餘選觸憲網齋齋鹽(餘選醖淵鑰製蓋積範願) = 艱選窪鬱鏇鑰廠構壓艱鑰蓋襯鏇蓋蓋膚簾夢鬱 (蓋夢獵網鹹壓範遞廠鬱, 遞餘窪鏇襯獵構願淵顧 ~ 鏇窪網艱蓋糧夢製餘構) 更多	-	2024-02-08
NCT04184622 (SURMOUNT-1, Literature) 人工标引	临床3期	肥胖	600	Tirzepatide 5 mg	選鑰廠襯糧築製簾餘製(繭鬱憲遞襯顧鑰顧顧鹽) = 夢憲鬱鏇夢選鹽鏇遞淵鑰齋夢齋範簾醖壓糧襯 (壓壓願衊艱廠顧築觸窪, - 10.0 ~ - 4.7) 更多	积极	2024-02-05
				Tirzepatide 10 mg	選鑰廠襯糧築製簾餘製(繭鬱憲遞襯顧鑰顧顧鹽) = 糧簾憲選衊膚遞壓鏇艱鑰齋夢齋範簾醖壓糧襯 (壓壓願衊艱廠顧築觸窪, - 13.2 ~ - 8.0) 更多