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 ; Abbasi, Siddique A ; Goldsmith, Steven ; 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&D

Evaluation of the Pharmacokinetics and Safety of AMG 986 Tablet and Capsule Formulations in Healthy Adult Subjects: A Phase I, Open-Label, Randomized Study

Article

作者: Cheng, Guilong Charles ; Mather, Omar ; Kiang, Y-H ; Lee, Edward ; Hellawell, Jennifer ; Saw, Robert E ; Trivedi, Ashit ; Vega, Silvia

BACKGROUND AND OBJECTIVEAMG 986 is a first-in-class, novel apelin receptor small molecule agonist initially developed for the treatment of heart failure. The current phase I study was conducted to evaluate the pharmacokinetics and safety of a single-dose 200-mg capsule formulation of AMG 986 relative to the tablet formulation in 12 healthy subjects.METHODSIn a two-period, two-way crossover design, eligible subjects were randomized 1:1 to tablet/capsule or capsule/tablet treatment sequences; each treatment sequence lasted for approximately 6 days and comprised six subjects.RESULTSFollowing a single oral dose of AMG 986, the geometric mean maximum observed concentration (C_max) values were 9670 ng/mL and 6920 ng/mL and the geometric mean area under the curve from time zero to 120 h (AUC_0-120h) values were 68,000 ng*h/mL and 59,900 ng*h/mL for the tablet and capsule, respectively. The geometric least squares means (90% confidence interval [90% CI]) for the ratios of capsule/tablet were 0.88 (90% CI 0.81-0.96) and 0.72 (90% CI 0.57-0.91) for AUC_0-120h and C_max, respectively. AMG 986 had an acceptable safety profile; all adverse events were grade 1 or 2 in severity.CONCLUSIONThere was a modest 12% decrease in AUC_0-120h and a 28% decrease in C_max with the AMG 986 capsule versus the tablet. These differences are not considered to be clinically relevant, suggesting the capsule formulation can be used in subsequent clinical studies of AMG 986.

项与 Azelaprag 相关的新闻（医药）

2024-09-04

·BioSpace

Lilly Partner BioAge Files for IPO to Advance Obesity Candidate

iStock, JHVEPhoto BioAge will use the proceeds from the initial public offering to move its oral apelin receptor agonist azelaprag past its Phase III STRIDES study and into a registrational Phase III trial. BioAge Labs revealed its plans for an initial public offering on Tuesday, as it looks to capitalize on the red-hot obesity medication market. The California-based biotech has not yet announced how much it expects to raise, nor has it set a completion date for the initial public offering (IPO). Once completed, BioAge will trade on the Nasdaq Global Market under the ticker symbol BIOA. The biotech is also offering its underwriters—Goldman Sachs, Citi, Jefferies and Morgan Stanley—a 30-day option to purchase additional shares of its common stock at the IPO price, minus discounts and commissions. According to BioAge, the primary objective of its IPO is to increase the company’s “financial flexibility” as well as to provide additional capital for its operations. The biotech will use the proceeds to advance its lead candidate azelaprag past its Phase III STRIDES study and into a registrational Phase III trial. Designed to be orally available, azelaprag is a small molecule activator of the apelin receptor which could help “recapitulate many of the benefits of exercise,” according BioAge. Azelaprag works by mimicking apeline, a protein that the body secretes in response to exercise, helping to potentially boost patients’ basal metabolic rate and insulin sensitivity while also inhibiting inflammation and muscle atrophy. Currently, the biotech is running a Phase II study assessing azelaprag with Eli Lilly’s blockbuster incretin therapy tirzepatide to help lower body weight, while also improving body composition. Topline data from the study are expected in the third quarter of 2025. BioAge also has plans to launch a Phase II study of azelaprag with Novo Nordisk’s semaglutide next year. BioAge will use the IPO funds to start a proof-of-concept study of azelaprag in insulin sensitivity, with an eye toward expanding its indication. A chunk of the IPO raise will also go toward developing its NLRP3 blocker for neuroinflammation. Tuesday’s IPO announcement comes after BioAge in February 2024 announced that it raised $170 million in an oversubscribed Series D funding round. Lilly Ventures, the venture capital arm of Eli Lilly, participated in the financing round. Lilly is also partnered with BioAge for the biotech’s Phase II trial of azelaprag. With its IPO, BioAge joins three other biotechs that have recently announced plans to go public. Last month, MBX Biosciences revealed its Nasdaq bid , the proceeds from which will help support its chronic hypoparathyroidism program. Cancer-focused Bicara Therapeutics and immunology player Zenas Biopharma also revealed IPO plans.

临床2期IPO临床3期

2024-09-03

·EndPoints

BioAge files for IPO, riding momentum for weight loss drugs

BioAge Labs is heading to Wall Street after months of speculation that the Eli Lilly-partnered cardiometabolic biotech was planning to join the public markets. The company’s investor prospectus officially dropped Tuesday afternoon , with the company planning to trade under the ticker BIOA. The offering is being underwritten by Goldman Sachs, Morgan Stanley, Jefferies and Citi. The company didn’t say how much it hopes to raise in the filing. BioAge has been one of the most closely-watched biotechs in the weight loss space, with its lead asset azelaprag a Phase 2 trial where it’s being tested alongside Lilly’s tirzepatide. A second Phase 2 study is set to begin in the first half of 2025, testing azelaprag with Novo Nordisk’s semaglutide. Azelaprag has piqued interest with early data showing it could help prevent muscle loss, one of the key drawbacks of the current class of incretin meds. The Phase 2 trial with Lilly is part of a larger collaboration between the two companies. Recently, Lilly’s venture arm participated in BioAge’s $170 million Series D financing. That round , which closed in February, was led by Sofinnova Investments and briefly landed managing partner Jim Healy as board chairman. Late last month, Healy stepped down from that role (but stayed on the board) and was replaced by former GSK CEO Jean-Pierre Garnier. Other investors in the latest round included RA Capital, OrbiMed and RTW Investments, among others. The biotech was co-founded and is led by CEO Kristen Fortney, who launched it nine years ago in 2015. It began with a broad focus on stymieing age-related degeneration but has since narrowed its work to the cardiometabolic field. Editor’s note: This story was updated to clarify that BioAge’s second Phase 2 study is planned for the first half of 2025.

IPO高管变更临床2期

2024-08-26

·药智网

GSK前高管入职减肥药公司

近日，BioAge Labs宣布，前葛兰素史克（GSK）首席执行官Jean-Pierre Garnier已加入公司，担任董事会主席。新锐减肥药公司 BioAge Labs于2015年成立，曾在2020年通过筹集9000万美元用于治疗衰老和与年龄相关的疾病而声名鹊起。今年2月，BioAge又筹集了1.7亿美元的D轮融资，以利用其apelin受体激动剂BGE-105（azelaprag）与GLP-1药物联合使用的潜力，开发新一代口服减肥药并保护肌肉质量。 Azelaprag引进自安进，不过安进曾试图开发其用于治疗心力衰竭。该药是一款艾帕素（apelin）受体激动剂。艾帕素是一种多肽，它通过与骨骼肌、心脏和中枢神经系统的相互作用调节新陈代谢，促进肌肉再生。近两年，减肥药市场火热，然而也暴露出部分缺陷，如减肥又减肌。诺和诺德的司美格鲁肽和礼来的替尔泊肽都面临这一挑战。而Bioage公司的azelaprag正是瞄准这一难题。Ib期临床数据显示，azelaprag能够在健康老年志愿者进行卧床休息期间，促进肌肉代谢，增加能量消耗，从而有效防止肌肉萎缩。此外，在临床前的研究中，azelaprag能使通过肠促胰岛素治疗实现的体重减轻效果加倍，并进一步改善了身体成分与肌肉功能。目前，BioAge已与礼来合作启动了一项2期临床试验，评估azelaprag与低剂量Zepbound（tirzepatide,5mg）联用治疗肥胖症的效果，目标是帮助人们在不损失肌肉的情况下减肥。再生元也在进行类似的研究，该公司计划通过与司美格鲁肽联合评估其肌肉保护药物的效果。与此同时，礼来去年收购了诺华子公司Versanis Bio，获得了一款新药bimagrumab，目前已开展联合tizepatide治疗肥胖的3期临床，有望实现减脂增肌. 此外，BioAge还将探索azelaprag在糖尿病和心脏病方面的潜力。 Garnier的新征程 Garnier曾在2000年至2008年担任GSK的首席执行官。在他的领导下，GSK完成了对Sirtris Pharmaceuticals的7.2亿美元收购，该公司主要研究白藜芦醇和其他sirtuin靶向药物用于延长寿命。不过，几年后GSK因效果不佳和副作用问题终止了后续开发并在2013年关闭了这家公司。离开GSK后，Garnier在Pierre Fabre担任了两年的首席执行官。之后Garnier又在多家生物技术公司的董事会中担任职位，包括Actelion、Cellectis和Idorsia。 Garnier入职BioAge，意味着这位制药界资深人士在16年后再次回归抗衰老领域。 BioAge公司CEO Kristen Fortney博士表示，Garnier在领导生物技术和制药公司通过关键增长阶段的丰富经验，将对BioAge的临床开发和代谢衰老疗法管线的推进具有重要价值。声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 小月石转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

并购临床3期临床2期高管变更引进/卖出

100 项与 Azelaprag 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
心脏衰竭	临床2期	新西兰	Amgen, Inc.	2016-08-12
心脏衰竭	临床2期	澳大利亚	Amgen, Inc.	2016-08-12
心脏衰竭	临床2期	美国	Amgen, Inc.	2016-08-12
心脏衰竭	临床2期	荷兰	Amgen, Inc.	2016-08-12
肌肉萎缩	临床2期	-	BioAge Labs, Inc.初创企业	-
肥胖	临床2期	-	BioAge Labs, Inc.初创企业	-
心脏衰竭	临床前	新加坡	Amgen, Inc.	2016-08-12
心脏衰竭	临床前	波兰	Amgen, Inc.	2016-08-12
心脏衰竭	临床前	加拿大	Amgen, Inc.	2016-08-12
心脏衰竭	临床前	法国	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	(繭艱糧艱蓋繭膚鏇遞膚) = 範簾繭築鹽築願窪蓋構製廠製鑰壓衊積衊夢製 (遞糧醖憲廠選鹹鹹膚網 ) 更多	积极	2022-12-05
				Placebo	(構鏇簾簾鏇鑰鏇獵壓蓋) = 膚鹽願壓遞鏇壓憲衊鬱糧壓齋艱鏇繭鹽壓積淵 (觸簾艱窪願壓壓簾願襯 )
NCT03276728 (CTgov)	临床1期	心脏衰竭	182	Placebo PO (Part C: HFrEF Placebo)	鑰積簾窪憲鏇夢憲製齋(積窪窪顧網範餘鹽鏇鏇) = 廠醖膚齋願選觸築鬱鏇鹹選蓋網選夢願淵網顧 (構顧窪淵窪鹹積鹽獵製, 衊鏇積窪簾鏇鏇齋鑰淵 ~ 繭繭鑰壓範範糧獵構願) 更多	-	2022-08-08
				Placebo PO (Part C: HFpEF Placebo)	鑰積簾窪憲鏇夢憲製齋(積窪窪顧網範餘鹽鏇鏇) = 獵淵齋顧夢衊壓壓齋選鹹選蓋網選夢願淵網顧 (構顧窪淵窪鹹積鹽獵製, 餘膚鹹醖選積壓繭餘願 ~ 膚醖鬱廠觸鏇鬱積齋蓋) 更多
NCT03318809 (CTgov)	临床1期	心脏衰竭	12	AMG 986 (Group 1: Severely Renal Impaired Participants)	觸壓鏇繭鹹襯鹽顧艱醖(網艱壓夢餘築夢遞蓋衊) = 醖範衊簾窪衊憲艱繭醖獵積蓋構觸淵鏇鏇餘蓋 (鬱遞顧膚築糧選衊築醖, 鏇觸壓觸觸窪顧醖窪顧 ~ 觸夢鑰鏇積餘觸簾築獵) 更多	-	2021-01-27
				AMG 986 (Group 2: Healthy Participants)	觸壓鏇繭鹹襯鹽顧艱醖(網艱壓夢餘築夢遞蓋衊) = 襯鏇積糧齋繭簾壓鑰獵獵積蓋構觸淵鏇鏇餘蓋 (鬱遞顧膚築糧選衊築醖, 鬱餘遞餘醖廠淵鏇齋鹽 ~ 觸願觸鏇憲膚網蓋觸遞) 更多