A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Proof-of-Concept Study to Investigate Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared with Tirzepatide Alone in Participants with Obesity Aged 55 Years and Over (STRIDES)

This study aims to find out how well a combination of oral azelaprag taken once a day (QD) or twice a day (BID), along with a weekly injection of tirzepatide, works for weight management in adults 55 years and older. The researchers are also looking at safety.
Estimated Study Length:
* with the optional prescreening, the study duration may be up to 48 weeks.
* the treatment duration will be 24 weeks followed by 12 weeks follow-up.
* the visit frequency will be every 2 weeks for the first 8 weeks of the treatment period and every 4 weeks thereafter.

开始日期2024-06-27

申办/合作机构

BioAge Labs, Inc.初创企业

[+1]

NCT06141889

/ Completed临床1期

A Phase 1, Single-dose, Open-label, Randomized Crossover and Multiple-dose, Open-label Study to Evaluate the Pharmacokinetics and Safety of Azelaprag in Older Adult Healthy Volunteers

This study is a single-dose, open-label, randomized crossover and multiple-dose, open-label study to evaluate the PK of azelaprag in older adult healthy volunteers.

开始日期2023-11-17

申办/合作机构

BioAge Labs, Inc.初创企业

NCT03318809

/ Completed临床1期

A Phase 1, Open-label, Single-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 986 Administered Orally to Healthy Volunteers and Subjects With Severely Impaired Renal Function

A study to assess the safety, tolerability, and pharmacokinetics of AMG 986 given orally as a single dose to healthy participants and participants with severely impaired kidney function.

开始日期2017-12-12

申办/合作机构

Amgen, Inc.

100 项与 Azelaprag 相关的临床结果

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100 项与 Azelaprag 相关的转化医学

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100 项与 Azelaprag 相关的专利（医药）

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项与 Azelaprag 相关的文献（医药）

2023-08-01·Cardiovascular Drugs and Therapy

A First-in-Human Study of AMG 986, a Novel Apelin Receptor Agonist, in Healthy Subjects and Heart Failure Patients

Article

作者: Hellawell, Jennifer ; Voors, Adriaan ; Winkle, Peter ; Hulot, Jean-Sebastien ; Kazemi, Navid ; Kaufman, Allegra ; Trivedi, Ashit ; Lepage, Serge ; Goldsmith, Steven ; Abbasi, Siddique A ; Koren, Michael J ; Neutel, Joel ; Troughton, Richard ; Tsirtsonis, Kate ; Donal, Erwan

PURPOSEAMG 986 is a novel apelin receptor (APJ) agonist that improves cardiac contractility in animal models without adversely impacting hemodynamics. This phase 1b study evaluated the safety/tolerability, pharmacokinetics, and pharmacodynamics of AMG 986 in healthy subjects and patients with heart failure (HF).METHODSHealthy adults (Parts A/B) and HF patients (Part C) aged 18-85 years were randomized 3:1 to single-dose oral/IV AMG 986 or placebo (Part A); multiple-dose oral/IV AMG 986 or placebo (Part B); or escalating-dose oral AMG 986 or placebo (Part C).PRIMARY ENDPOINTtreatment-emergent adverse events, laboratory values/vital signs/ECGs; others included AMG 986 pharmacokinetics, left ventricular (LV) function.RESULTSOverall, 182 subjects were randomized (AMG 986/healthy: n = 116, placebo, n = 38; AMG 986/HF: n = 20, placebo, n = 8). AMG 986 had acceptable safety profile; no clinically significant dose-related impact on safety parameters up to 650 mg/day was observed. AMG 986 exposures increased nonlinearly with increasing doses; minimal accumulation was observed. In HF with reduced ejection fraction patients, there were numerical increases in percent changes from baseline in LV ejection fraction and stroke volume by volumetric assessment with AMG 986 vs placebo (stroke volume increase not recapitulated by Doppler).CONCLUSIONSIn healthy subjects and HF patients, short-term AMG 986 treatment was well tolerated. Consistent with this observation, clinically meaningful pharmacodynamic effects in HF patients were not observed. Changes in ejection fraction and stroke volume in HF patients suggest additional studies may be needed to better define the clinical utility and optimal dosing for this molecule.TRIAL REGISTRATION NUMBERClinicalTrials.gov NCT03276728.DATE OF REGISTRATIONSeptember 8, 2017.

2022-07-01·Clinical Pharmacology in Drug Development

A Phase 1, Open‐Label Study to Evaluate the Effect of Food and Concomitant Itraconazole Administration on the Pharmacokinetics of AMG 986 in Healthy Subjects

Article

作者: Mather, Omar ; Vega, Silvia ; Hutton, Shauna ; Hellawell, Jennifer ; Lee, Edward ; Trivedi, Ashit

AbstractThis phase 1, open‐label study evaluated the effect of food and administration of the cytochrome P450 3A4 and P‐glycoprotein inhibitor itraconazole (ITZ) on the pharmacokinetics of AMG 986. In cohort 1, 12 healthy subjects received a single oral dose of AMG 986 200 mg ± food on days 1 and 10. In cohort 2, 15 healthy subjects received oral ITZ 200 mg once daily on days 8 to 15 and a single oral dose of AMG 986 10 mg on days 1 and 11. The geometric least squares mean ratios of fed/fasted for AMG 986 maximum observed concentration (Cmax) and area under the plasma concentration–time curve from time 0 to infinity (AUCinf) were 0.76 (90%CI, 0.61‐0.95) and 1.07 (90%CI, 0.94‐1.22), respectively. The geometric least squares mean ratios of AMG 986 10 mg plus ITZ 200 mg/AMG 986 10 mg alone for AMG 986 Cmax and AUCinf were 1.36 (90%CI, 1.25‐1.48) and 5.13 (90%CI, 4.71‐5.59), respectively. Overall, 3 subjects experienced mild treatment‐related adverse events; there were no serious or fatal adverse events. In conclusion, food had no apparent effect on the exposure of AMG 986 200 mg; therefore, food restrictions are not required. Potent cytochrome P450 3A4 and/or P‐glycoprotein inhibitors may warrant AMG 986 dose reduction and should be coadministered with caution in patients with heart failure treated with AMG 986.

2022-06-01·Drugs in R&D4区 · 医学

A Phase I, Open-label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of AMG 986 in Healthy Japanese Subjects

4区 · 医学

ArticleOA

作者: Hellawell, Jennifer ; Mather, Omar ; Hutton, Shauna ; Vega, Silvia ; Trivedi, Ashit ; Lee, Edward

BACKGROUND AND OBJECTIVEAMG 986 is a first-in-class, novel apelin receptor small molecule agonist initially developed as a treatment for patients with heart failure (HF). Previously, a first-in-human study of AMG 986 was conducted in healthy and HF subjects; however, AMG 986 was not evaluated in Japanese subjects.METHODSThis was a phase I, open-label, single-dose, single-center study conducted to evaluate the safety and pharmacokinetics (PK) of AMG 986 200 mg and 400 mg in 12 healthy Japanese subjects. Six subjects received AMG 986 200 mg and six subjects received AMG 986 400 mg.RESULTSFollowing oral administration, median time to maximum observed plasma concentration (t_max) was 1.0 h for both the AMG 986 200 mg and 400 mg groups, and mean terminal half-life (t_½) was 15.1 h and 17.6 h, respectively. When comparing the AMG 986 200 mg and 400 mg groups, 1.33-fold and 1.18-fold higher maximum observed plasma concentration (C_max) and AUC_∞, respectively, were observed for the 2-fold increase in dose. AMG 986 exhibited an acceptable safety and tolerability profile; all adverse events were mild in severity.CONCLUSIONAMG 986 exposure increased with increasing dose, and the increase was less than dose proportional in healthy Japanese subjects. The results of this study could facilitate the subsequent clinical development of AMG 986 for the treatment of Japanese patients with HF.

项与 Azelaprag 相关的新闻（医药）

2025-01-09

·智药邦

AI+衰老药物发现｜BioAge与诺华开展多年合作，预付款2000万美元

2024年12月18日，通过针对人类衰老生物学开发代谢性疾病的候选治疗产品的临床阶段生物制药公司BioAge Labs，宣布与诺华进行多年研究合作。该合作旨在通过研究驱动与衰老相关疾病的生物学机制和介导体育锻炼的有益作用，鉴定和验证多种新型治疗药物靶点。 BioAge针对衰老问题的研究集中在3个方向，分别是代谢和肌肉衰老、大脑衰老、免疫衰老。同时，依托独有的AI药物发现平台，BioAge还拥有多条在研管线，适应症包括肥胖症、神经炎症、急性肌肉萎缩等与衰老相关的疾病。 2019年，BioAge宣布完成2300万美元B轮融资，该轮资金推动了公司搭建基于AI技术的高通量目标识别平台，即AI药物发现平台。该平台能够在海量的数据中搜索并确定影响人类寿命的关键生物途径和药物靶点，并通过高通量生物验证、最终将潜在靶点推进临床开发阶段。经过多年创新发展，BioAge的平台目前建立在一个拥有45年长度的纵向样本和健康记录的数据库上，拥有150万多个临床数据点、6400万多个分子数据点共6550万多个数据点，每年可评估约20种衰老途径。其中，该平台的最大优势是根据纵向数据跟踪患者衰老结果，从而确定导致衰老发生的新机制和驱动因素，并在已知和新型衰老生物学的交叉点上识别全新靶点。 BioAge的首席执行官兼联合创始人Kristen Fortney表示：“我们的平台建立在广泛的人类纵向寿命数据的基础上，使我们能够确定有前景的治疗途径，这些途径具有改善健康结果的巨大潜力。与诺华的合作展示了我们平台的价值，并扩大了我们根据数据洞察发现和开发新靶点的能力。” 此次合作将利用BioAge广泛的专有人类寿命数据集和诺华在运动生物学方面的专业知识。BioAge的专有发现平台基于对长达50年的纵向人类衰老队列的独家访问，结合了详细的健康记录和功能测量。将先进的分析和机器学习技术应用于这个丰富的数据集，使BioAge能够识别健康寿命的决定因素，为治疗发现和开发提供引擎。诺华生物医学研究公司衰老和再生医学（DARe）疾病全球负责人Michaela Kneissel表示：“我们很高兴与BioAge合作，将他们的人类寿命数据与我们在体育锻炼生物学方面的科学专业知识结合起来，发现新的治疗靶点。通过探索人类衰老生物学与体育锻炼有益作用的生物学驱动因素的交叉点，我们的目标是为与衰老相关的疾病提出新的治疗方案。” 根据协议条款，BioAge将获得高达2000万美元的预付款和研究资金，以及未来高达5.3亿美元的长期研究、开发和商业里程碑。诺华和BioAge都有权推进在合作中发现的新靶点，并且都有资格获得互惠的成功里程碑和分层版税。关于BioAge Labs BioAge是一家临床阶段的生物制药公司，通过针对人类衰老的生物学来开发代谢性疾病的候选治疗产品。BioAge的主要候选产品azelaprag是一种口服的APJ小分子激动剂，在1b期临床试验中观察到它可以促进代谢并预防卧床休息时的肌肉萎缩。BioAge还在开发口服小分子脑渗透剂NLRP3抑制剂，用于治疗由神经炎症引起的疾病。BioAge的临床前项目基于该公司基于人类寿命数据的发现平台的新见解，解决了代谢衰老的关键途径。在AI平台的支持下，BioAge针对衰老领域中的不同适应症布局了多条在研管线，除了核心管线Azelaprag外，还包括BGE-100。BGE-100是一种NLRP3（NOD样受体热蛋白结构域相关蛋白3）抑制剂，被开发用于治疗由神经炎症引起的神经退行性疾病，帮助延长患者寿命。BioAge预计将提交新药研究申请（IND），如果获得批准BGE-100将于2026年上半年开始1期临床试验。参考资料： https://ir.bioagelabs.com/news-releases/news-release-details/bioage-labs-announces-multi-year-collaboration-novartis-discover --------- End --------- 感兴趣的读者，可以添加小邦微信加入读者实名讨论微信群。添加时请主动注明姓名-企业-职位/岗位或姓名-学校-职务/研究方向。

引进/卖出

2025-01-08

·PRNewswire

BIOA INVESTOR ALERT: Edelson Lechtzin LLP Urges BioAge Labs, Inc. (NASDAQ: BIOA) Shareholders to Consult Legal Counsel About the Impending Lead Plaintiff Deadline in the Securities Fraud Class Action

NEWTOWN, Pa., Jan. 8, 2025 /PRNewswire/ -- Edelson Lechtzin LLP, a leading class action law firm, is investigating securities fraud claims on behalf of all investors of BioAge Labs, Inc. (NASDAQ: BIOA) who purchased stock pursuant and/or traceable to BioAge Labs' registration statement issued in connection with the company's initial public offering (the "IPO") on September 26, 2024. To join this case, go HERE. Investors who purchased BioLabs stock may move the U.S. District Court for the Northern of California to appoint them as a lead plaintiff, no later than March 10, 2025. Please contact Edelson Lechtzin LLP at 844-696-7492 ext. 1, or by e-mail at [email protected] to discuss your investment losses. Background on BioAge Labs, Inc. BioAge Labs, located in Richmond, California, is a clinical-stage biopharmaceutical company focused on developing therapeutic candidates for metabolic diseases. The Securities Fraud Claims. The Complaint alleges that the offering documents for the company's IPO contained materially false and misleading statements. These documents indicated to the public that there were no safety concerns regarding BioAge Labs and that the company expected to achieve positive top-line results in the third quarter of 2025 while meeting its primary endpoint goals related to the STRIDES clinical trial. BioAge Labs completed its IPO on September 27, 2024, selling 12.65 million shares at a price of $18 each. However, on December 6, 2024, BioAge Labs announced that it was discontinuing the Phase 2 STRIDES study of its investigational drug candidate, azelaprag. This decision was made after liver transaminitis was observed in some subjects receiving azelaprag. An analyst commented on the announcement, stating that it was surprising since liver toxicity had never been reported in the eight Phase 1 studies previously conducted by BioAge Labs. On this news, the price of BioAge's stock fell from $20.09 per share on December 6, 2024, to $4.65 per share on December 7, 2024, a decline of more than 76%. For more information, please contact: Marc H. Edelson, Esq. Eric Lechtzin, Esq. EDELSON LECHTZIN LLP 411 S. State Street, Suite N-300 Newtown, PA 18940 Phone: 844-696-7492 or 215-867-2399 ext. 1 Email: [email protected] Email: [email protected] Web: Edelson Lechtzin LLP is a leading class action law firm with offices in Pennsylvania and California. In addition to cases involving securities and investment fraud, our lawyers focus on class and collective litigation in cases alleging violations of the federal antitrust laws, employee benefit plans under ERISA, wage theft and unpaid overtime, consumer fraud, and catastrophic injuries. This press release may be considered Attorney Advertising in some jurisdictions. No class has been certified in this case, so you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. Your ability to share in any potential future recovery is not dependent upon serving as lead plaintiff. SOURCE Edelson Lechtzin LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

IPO

2025-01-03

·PRNewswire

BioAge Labs (BIOA) Shares Plummet After Discontinuing Trial Just 2 Months After IPO- Hagens Berman

SAN FRANCISCO, Jan. 3, 2025 /PRNewswire/ -- Shares of BioAge (NASDAQ: BIOA) have plummeted since the company's December 6 announcement of the discontinuation of a Phase 2 trial for its weight-loss drug azelaprag due to safety concerns. The abrupt halt comes just a little over two months after the company raised $198 million in a highly anticipated initial public offering in late September. Hagens Berman has opened an investigation into whether BioAge's IPO documents may have contained misstatements or omissions and urges investors who suffered substantial losses to submit your losses now. Visit: Contact the Firm Now: [email protected] 844-916-0895 BioAge Labs, Inc. (BIOA) Investigation: On September 25, 2024, BioAge went public with considerable fanfare, pricing 11 million shares at $18 per share, with renowned Wall Street banks Goldman Sachs, Morgan Stanley, Jefferies and Citigroup serving as lead bookrunners. Investor enthusiasm was fueled by the company's lead drug, azelaprag, licensed from Amgen. Preclinical data had suggested that azelaprag, when combined with other therapies, could significantly aid weight loss while preserving muscle mass, according to the IPO documents. The company said it had initiated a Phase 2 trial of azelaprag in combination with Eli Lilly's tirzepatide, also known as Mounjaro and Zepbound, with initial results expected in the third quarter of 2025. However, on December 6, BioAge announced the discontinuation of the trial after observing elevated liver enzymes in several patients receiving azelaprag, leading the company to halt dosing and enrollment in the trial. BioAge informed the FDA of its decision and stated it would provide an updated plan for the drug in the first quarter of 2025. The news sent BioAge shares tumbling nearly 80% on December 9. This news drove the price of BioAge shares down almost 80% on December 9, 2024. The recent disclosure and precipitous stock drop have driven shareholder rights firm Hagens Berman to open an investigation. "We are investigating whether BioAge adequately disclosed the potential safety risks associated with azelaprag in its IPO filings," said Reed Kathrein, the Hagens Berman partner leading the investigation. "Investors deserve to be fully informed about the risks they are taking when investing in a biotech company's IPO." If you invested in BioAge and have substantial losses, or have knowledge that may assist the firm's investigation, submit your losses now » If you'd like more information and answers to frequently asked questions about the BioAge investigation, read more » Whistleblowers: Persons with non-public information regarding BioAge should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected]. About Hagens Berman Hagens Berman is a global plaintiffs' rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman's team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw. SOURCE Hagens Berman Sobol Shapiro LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

IPO临床2期上市批准

100 项与 Azelaprag 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肌肉萎缩	临床2期	-	BioAge Labs, Inc.初创企业	-
心脏衰竭	临床前	新西兰	Amgen, Inc.	2016-08-12
心脏衰竭	临床前	德国	Amgen, Inc.	2016-08-12
心脏衰竭	临床前	荷兰	Amgen, Inc.	2016-08-12
心脏衰竭	临床前	加拿大	Amgen, Inc.	2016-08-12
肥胖	临床前	-	BioAge Labs, Inc.初创企业	-
心脏衰竭	药物发现	新加坡	Amgen, Inc.	2016-08-12
心脏衰竭	药物发现	法国	Amgen, Inc.	2016-08-12
心脏衰竭	药物发现	美国	Amgen, Inc.	2016-08-12
心脏衰竭	药物发现	波兰	Amgen, Inc.	2016-08-12

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


BusinessWire 人工标引	临床1期	肌肉萎缩	21	BGE-105	(鏇鑰遞壓鏇願鬱膚衊醖) = 壓壓糧淵憲繭顧壓獵窪鬱淵膚憲築壓繭窪積顧 (鏇遞獵醖願膚鑰膚鏇鏇 ) 更多	积极	2022-12-05
				Placebo	(鏇獵鑰淵鑰構齋簾築鹹) = 糧築襯鑰憲鹽簾構築積鏇廠網鹹窪壓積願餘窪 (網衊遞鏇獵醖積鏇製膚 )
NCT03276728 (CTgov)	临床1期	心脏衰竭	182	Placebo PO (Part C: HFrEF Placebo)	願艱範憲網鑰鬱鬱鹹糧(蓋餘壓醖鏇顧繭獵鑰簾) = 鏇壓壓艱鑰膚糧蓋窪壓餘鏇積簾選繭膚鑰願築 (鏇選積顧範鏇鑰選窪觸, 蓋蓋網廠獵願觸築糧襯 ~ 網齋夢獵積餘夢餘壓襯) 更多	-	2022-08-08
				Placebo PO (Part C: HFpEF Placebo)	願艱範憲網鑰鬱鬱鹹糧(蓋餘壓醖鏇顧繭獵鑰簾) = 襯積艱鏇窪憲選簾齋淵餘鏇積簾選繭膚鑰願築 (鏇選積顧範鏇鑰選窪觸, 蓋壓壓糧廠遞範蓋壓鏇 ~ 廠醖壓艱鹽願選鏇憲選) 更多
NCT03318809 (CTgov)	临床1期	心脏衰竭	12	AMG 986 (Group 1: Severely Renal Impaired Participants)	製鏇獵鏇願鹽願選繭衊(夢蓋醖窪築範蓋網網積) = 獵簾願鹽製網廠廠製獵窪襯選壓遞願製廠鑰夢 (醖鏇構鬱蓋壓鬱鏇蓋襯, 襯艱膚繭鏇鑰鬱夢獵夢 ~ 簾製構衊窪醖糧窪網鹹) 更多	-	2021-01-27
				AMG 986 (Group 2: Healthy Participants)	製鏇獵鏇願鹽願選繭衊(夢蓋醖窪築範蓋網網積) = 窪鬱鏇窪廠遞膚鹹築獵窪襯選壓遞願製廠鑰夢 (醖鏇構鬱蓋壓鬱鏇蓋襯, 艱願鑰鏇觸繭餘艱襯齋 ~ 網壓築築選淵憲鑰構鬱) 更多