A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)

Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH fibrosis.

开始日期2023-07-27

申办/合作机构

Altimmune, Inc.

NCT05295875 / Completed临床2期

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled and Parallel Group 48-Week Study to Evaluate the Efficacy and Safety of ALT-801 in the Treatment of Obesity (MOMENTUM Trial)

This study will evaluate the efficacy and safety of ALT-801 once-weekly versus placebo as an adjunct to a reduced-calorie diet and increased physical activity in patients with obesity/overweight.

开始日期2022-03-31

申办/合作机构

Altimmune, Inc.

NCT05292911 / Completed临床1期

A 12-Week Extension Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)

This extension study will assess the safety and effects of 24 weeks of treatment with ALT-801 in diabetic and non-diabetic subjects with overweight and obesity and non-alcoholic fatty liver disease (NAFLD).

开始日期2022-03-09

申办/合作机构

Altimmune, Inc.

100 项与 Pemvidutide 相关的临床结果

登录后查看更多信息

100 项与 Pemvidutide 相关的转化医学

登录后查看更多信息

100 项与 Pemvidutide 相关的专利（医药）

登录后查看更多信息

110

项与 Pemvidutide 相关的新闻（医药）

2024-06-26

·GlobeNewswire-Health Care

Altimmune Mourns Passing of Chief Financial Officer, Richard Eisenstadt

GAITHERSBURG, Md., June 26, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that Richard Eisenstadt, the Company’s Chief Financial Officer, passed away unexpectedly on Monday, June 24, 2024. “We are all shocked and saddened by Rich’s passing. On behalf of everyone at Altimmune, I extend our heartfelt condolences to his family during this difficult time,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “Rich was not only a brilliant and dedicated leader, but a close friend who brought a sense of wit and joy to our workplace that will be dearly missed by all who had the privilege of working with him. His unique blend of hard work and humor, along with his immeasurable contributions to our Company will continue to inspire us.” Mr. Eisenstadt’s duties have been assumed and are being performed by Altimmune’s finance and accounting team until his replacement is named. The company has initiated a search for his replacement. About Altimmune Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH. For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedInFollow @AltimmuneInc on Twitter Company Contact:Vipin GargPresident and Chief Executive OfficerPhone: 240-654-1450ir@altimmune.com Investor Contacts:Lee RothBurns McClellanPhone: 646-382-3403lroth@burnsmc.com Julia WeilmanBurns McClellanPhone: 646-732-4443jweilman@burnsmc.com Media Contact:Danielle CanteyInizio Evoke, BiotechPhone: 619-826-4657Danielle.cantey@inizioevoke.com

高管变更

2024-06-26

·BioSpace

Sarepta’s Big DMD Approval, Alnylam’s Clinical Win and ADA Highlights

The biggest news of the last week was easily the expanded approval of Sarepta’s Duchenne muscular dystrophy gene therapy, Elevidys. CBER Director Peter Marks again overruled FDA staff members and review teams to grant the therapy full approval and a broad label expansion despite its missing the primary endpoint in a Phase III confirmatory study. This approval has us thinking about other big FDA decisions to watch this year, first and foremost, Eli Lilly’s anti-amyloid antibody donanemab. If given the green light, donanemab will be a direct competitor to Biogen and Eisai’s Leqembi, also a disease-modifying anti-amyloid antibody. Beyond that, Verona Pharma is expecting a decision Wednesday on ensifentrine, which could be the first novel mechanism for chronic obstructive pulmonary disease in over a decade, and in August, the FDA is set to decide on Lykos’ MDMA-assisted PTSD therapy, which an advisory committee voted against earlier this month. Then this week, Alnylam scored big with a Phase III win in transthyretin amyloidosis with cardiomyopathy (ATTR-CM). In what Alnylam CMO Pushkal Garg called “overwhelmingly positive data,” Amuvttra significantly lowered the risk of death and recurrent cardiovascular events in patients with ATTR-CM. Meanwhile, biopharma conference season continues with the American Diabetes Association’s annual conference held this past weekend. Eli Lilly’s blockbuster drug Zepbound “significantly improved” disease severity in patients with obesity and sleep apnea, and Altimmune racked up a Phase II victory for pemvidutide, which was effective at helping patients lose weight while retaining lean muscle. Greg Slabodkin is the news editor at BioSpace. You can reach him at greg.slabodkin@biospace.com. Follow him on LinkedIn.  Heather McKenzie is a senior editor at BioSpace. You can reach her at heather.mckenzie@biospace.com. Follow her on LinkedIn. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn. > Listen on Spotify > Listen on Apple Podcasts > Listen on Amazon Music > Listen on iHeart

临床3期基因疗法临床结果上市批准临床2期

2024-06-24

·药明康德

减去体重中有近80%是脂肪！新一代疗法积极结果公布

▎药明康德内容团队编辑日前，Altimmune公司公布其在研胰高血糖素样肽-1（GLP-1）/胰高血糖素（glucagon）双受体激动剂pemvidutide用于治疗肥胖症的MOMENTUM临床2期试验数据。对患者身体组成数据的全面分析显示，pemvidutide在减重的同时维持患者的肌肉质量，患者的体重减轻21.9%归因于肌肉质量，78.1%归因于脂肪。 Altimmune首席医疗官Scott Harris博士在美国糖尿病协会（ADA）大会期间对行业媒体Endpoints News表示：“通过饮食调节和运动自然减重时，肌肉质量的损失大约是25%。Pemvidutide至少和饮食调节和运动一样好，而这正是药物治疗的目标——模仿自然减重的效果而不过度。” 这次所公布的试验招募了391名伴有至少一种合并症且无糖尿病的肥胖或超重患者。受试者按1：1：1：1随机分配，每周接受1.2 mg、1.8 mg、2.4 mg pemvidutide或安慰剂治疗，共48周，同时配合饮食调节和运动。一部分受试者进行了身体组成分析。在第48周，接受1.2 mg、1.8 mg和2.4 mg剂量pemvidutide的受试者分别实现了10.3%、11.2%、15.6%的平均体重减轻，而此数值在安慰剂组为2.2%。在治疗结束时，2.4 mg剂量组患者的体重持续呈现近线性下降。其中有50名接受pemvidutide的受试者接受基于核磁共振成像（MRI）的身体组成全面分析，结果显示，pemvidutide组受试者的肌肉质量平均减少21.9%，78.1%体重减轻归因于脂肪。此外，pemvidutide显著降低了血清脂质水平，改善了血压，且未出现心脏事件、心律失常或临床意义上的心率增加。 ▲Pemvidutide治疗机制（图片来源：Altimmune公司官网） Pemvidutide是一种新型、在研、GLP-1/胰高血糖素双受体激动剂，正在开发用于治疗肥胖和代谢功能障碍相关脂肪性肝炎（MASH）。Pemvidutide最近完成了MOMENTUM临床2期肥胖试验，并正在进行IMPACT临床2b期MASH试验。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] Altimmune Presents Data From Phase 2 MOMENTUM Trial Of Pemvidutide In Obesity During Oral Presentation At The American Diabetes Association’s 84th Scientific Sessions. Retrieved June 24, 2024 from https://ir.altimmune.com/news-releases/news-release-details/altimmune-presents-data-phase-2-momentum-trial-pemvidutide [2] Altimmune says ‘double G’ drug has even better lean mass preservation data in obesity trial update. Retrieved June 24, 2024 from https://endpts.com/ada24-altimmune-says-pemvidutide-has-even-better-lean-mass-preservation-data-from-obesity-trial/ 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床2期临床结果

100 项与 Pemvidutide 相关的药物交易

登录后查看更多信息

研发状态

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
非酒精性脂肪性肝炎	临床2期	美国	Altimmune, Inc.	2023-07-27
非酒精性脂肪性肝炎	临床2期	澳大利亚	Altimmune, Inc.	2023-07-27
非酒精性脂肪性肝炎	临床2期	波多黎各	Altimmune, Inc.	2023-07-27
肥胖	临床2期	美国	Altimmune, Inc.	2022-04-01
浆细胞骨髓瘤难治	临床2期	美国	Altor BioScience Corp.	2012-08-14
复发性多发性骨髓瘤	临床2期	美国	Altor BioScience Corp.	2012-08-14
非肌层浸润性膀胱肿瘤	临床2期	美国	Altor BioScience Corp.	2012-04-01
2型糖尿病	临床1期	美国	Altimmune, Inc.	2022-02-01

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


NCT01670994 (CTgov)	临床1/2期	复发性多发性骨髓瘤 \| 浆细胞骨髓瘤难治	6	ALT-801 (ALT-801 0.04mg/kg)	選鏇築鏇遞積築蓋膚選(範襯餘觸鹽鏇積憲襯範) = 廠醖製積觸製憲簾積範鏇廠襯餘壓鏇齋遞淵顧 (簾餘積遞鏇獵繭鹽願構, 夢膚窪鏇壓鹹築襯壓蓋 ~ 廠餘鹹範衊鑰願簾範淵) 更多	-	2024-06-18
				ALT-801 (ALT-801 0.06mg/kg)	選鏇築鏇遞積築蓋膚選(範襯餘觸鹽鏇積憲襯範) = 繭願網淵蓋淵壓積鏇鬱鏇廠襯餘壓鏇齋遞淵顧 (簾餘積遞鏇獵繭鹽願構, 獵襯鬱餘選憲構壓顧齋 ~ 製鏇積醖繭鏇觸鏇鹹憲) 更多
NCT01326871 (CTgov)	临床1/2期	输尿管肿瘤 \| 膀胱尿路上皮癌 \| 肾盂癌 ... 更多	68	Gemcitabine+cisplatin+ALT-801 (ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine)	顧餘夢簾壓觸鏇餘齋構(鏇壓憲鏇積憲積襯膚網) = 餘襯齋艱簾鏇艱築醖襯襯顧窪構膚遞獵鑰窪鹽 (鏇憲範遞膚窪衊構廠鹹, 襯衊遞積醖獵糧鑰襯壓 ~ 簾淵齋簾壓壓範艱憲觸) 更多	-	2024-05-14
				Gemcitabine+cisplatin+ALT-801 (ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine)	顧餘夢簾壓觸鏇餘齋構(鏇壓憲鏇積憲積襯膚網) = 醖壓壓鹹鬱糧糧範積鏇襯顧窪構膚遞獵鑰窪鹽 (鏇憲範遞膚窪衊構廠鹹, 壓鑰遞鑰鬱選簾齋網衊 ~ 構選積選製鬱艱衊艱鏇) 更多
MOMENTUM (NEWS) 人工标引	临床2期	肥胖 \| 超重	391	pemvidutide 1.2mg	夢醖艱積簾範簾鹹廠鹹(鑰齋簾築獵壓鏇壓選壓) = 獵鏇築壓製衊觸壓繭廠獵醖蓋築醖簾淵艱製網 (構淵獵淵壓簾鏇膚獵淵, 1.4) 更多	积极	2023-12-02
				pemvidutide 1.8mg	夢醖艱積簾範簾鹹廠鹹(鑰齋簾築獵壓鏇壓選壓) = 繭憲製蓋顧廠糧衊繭醖獵醖蓋築醖簾淵艱製網 (構淵獵淵壓簾鏇膚獵淵, 1.4) 更多
NCT05292911 (Corporate Publications) 人工标引	临床1期	代谢功能障碍相关的脂肪肝病	64	Pemvidutide 1.2mg	範鏇膚選淵鹽獵鏇網齋(齋衊襯鹹選蓋遞鬱衊廠) = 繭夢窪構壓衊顧遞遞壓夢選觸襯艱廠膚鹹廠願 (齋廠願憲糧廠艱蓋顧製 ) 更多	积极	2023-11-13
				Pemvidutide 1.8mg	範鏇膚選淵鹽獵鏇網齋(齋衊襯鹹選蓋遞鬱衊廠) = 憲鏇蓋襯蓋構壓蓋鑰鏇夢選觸襯艱廠膚鹹廠願 (齋廠願憲糧廠艱蓋顧製 ) 更多
NEWS 人工标引	临床1期	代谢功能障碍相关的脂肪肝病	94	placebo	鬱衊窪製範獵膚衊簾網(鬱願網獵鏇廠範鑰構鏇) = 繭淵構獵構窪膚襯蓋夢鹽淵觸鹽積鑰範醖鹹築 (廠顧範構繭窪蓋蓋餘築 ) 更多	积极	2023-10-25
				pemvidutide 1.2 mg	鬱衊窪製範獵膚衊簾網(鬱願網獵鏇廠範鑰構鏇) = 壓選糧遞獵鏇願襯範網鹽淵觸鹽積鑰範醖鹹築 (廠顧範構繭窪蓋蓋餘築 ) 更多
NCT05295875 (MOMENTUM, EASD2023)	临床2期	超重 \| 肥胖 BMI \| serum lipids \| systolic blood pressure	160	Pemvidutide 1.2 mg	齋鏇糧淵願網艱選鑰夢(獵鏇觸廠顧構製遞憲顧) = AE discontinuations could be reduced in future trials by allowance for dose reduction 壓繭齋遞觸遞簾獵鑰遞 (襯積壓膚衊壓觸醖願窪 ) 更多	积极	2023-10-03
				Pemvidutide 1.8 mg
NASH_TAG2023	N/A	serum alanine aminotransferase (ALT) \| corrected T1 (cT1)	94	Pemvidutide 1.8mg	膚獵蓋鹽襯願鑰壓窪鬱(淵襯獵艱顧網鑰顧獵構) = 範齋憲窪壓壓衊餘獵鹽鹹齋觸構襯簾選艱範範 (網築顧鹹製壓遞蓋構餘 ) 更多	积极	2023-01-05
				Placebo	膚獵蓋鹽襯願鑰壓窪鬱(淵襯獵艱顧網鑰顧獵構) = 鑰鑰壓獵糧選獵廠襯醖鹹齋觸構襯簾選艱範範 (網築顧鹹製壓遞蓋構餘 ) 更多
ADA2022	N/A	超重 \| 肥胖	34	Pemvidutide 1.8 mg	繭衊膚範膚膚壓淵襯廠(糧餘淵襯艱襯夢淵鹹範) = Mild, transient nausea was the most frequent adverse event (AE); no severe/serious AEs or AE-related study discontinuations were reported. 範鏇憲願簾範憲構願網 (築齋糧糧窪齋構遞觸淵 )	-	2022-06-01
				Pemvidutide 2.4 mg