A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of Multiple Dose Regimens of Once-Weekly Switching to Once-Monthly MET097 in Participants With Obesity or Overweight (VESPER-3)

This study is designed to test the weight loss effects, safety, and tolerability of multiple monthly doses of MET097 after 12 weekly doses, compared to placebo. Participants are eligible if they have overweight or obesity and do not have type 2 diabetes.

开始日期2025-04-01

申办/合作机构

Metsera, Inc.

NCT06897202

/ Recruiting临床2期

A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight, and Type 2 Diabetes Mellitus (VESPER-2)

This study is designed to test how well once-weekly MET097 (an ultra-long-acting GLP-1 receptor agonist) works to treat adults with obesity or overweight and type 2 diabetes mellitus (T2DM) compared to placebo. MET097 or placebo will be administered to individuals via subcutaneous injection once weekly for 28 weeks. If an individual is randomly assigned to MET097 they will receive one of four different dose regimens.

开始日期2025-03-14

申办/合作机构

Metsera, Inc.

NCT06924320

/ Recruiting临床1期

A Phase 1 Randomized, Double-Blind, Placebo Controlled. Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MET233 Co-administered With MET097 in Adult Participants With Obesity or Overweight Including Participants With Type 2 Diabetes Mellitus

This study is designed to test how well the combination of MET233 with MET097 works to treat individuals with obesity or overweight with or without diabetes.

开始日期2025-03-03

申办/合作机构

Metsera, Inc.

100 项与 MET-097 相关的临床结果

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100 项与 MET-097 相关的转化医学

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100 项与 MET-097 相关的专利（医药）

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项与 MET-097 相关的文献（医药）

2025-07-01·DIABETES & METABOLISM

SGLT2 inhibitor, GLP-1 receptor agonist, and dementia risk

Letter

作者: Lai, Shih-Wei

2025-07-01·INTERNATIONAL JOURNAL OF OBESITY

Real -world experience with anti-obesity medications treatment in children and adolescents with overweight and obesity in Israel

Article

作者: Phillip, Moshe ; Yackobovitch-Gavan, Michal ; Shalitin, Shlomit

Abstract:

Background:

Childhood obesity is a major public health concern, associated with early-onset comorbidities and a high likelihood of persisting into adulthood. Anti-obesity medications (AOMs) may serve as an adjunct to lifestyle modifications for managing pediatric obesity.

Objective:

To evaluate prescribing patterns, weight outcomes, and cardiometabolic impacts of AOMs among children and adolescents aged 10–18 years within Clalit Health Services (CHS), the largest health maintenance organization in Israel.

Subjects/Methods:

This retrospective observational study analyzed data from CHS’s electronic database (2017–2024). The study cohort included 307 208 children with BMI measurements exceeding World Health Organization (WHO)-defined thresholds for overweight or obesity. Among these, 2236 (0.7%) were prescribed AOMs (metformin, GLP-1 receptor agonist, or orlistat). A secondary analysis assessed longitudinal changes in BMI z-scores and cardiometabolic parameters among individuals who purchased at list two prescriptions of AOMs.

Results:

AOMs prescriptions were more common among females, younger patients, those with higher BMI z-scores, and medium-to-high socioeconomic position (SEP) levels. Children prescribed AOMs exhibited a higher prevalence of obesity-related comorbidities and greater engagement with dietitians and endocrine specialists. Metformin was the most commonly prescribed medication (73.8%), followed by GLP-1 receptor agonist (24.5%) and orlistat (1.7%). Females demonstrated higher rates of medication adherence and longer treatment durations than males. Among the 1717 participants with ≥2 AOMs purchases, BMI z-scores significantly declined during treatment, accompanied by reductions in blood glucose, HbA1c, triglycerides, and total cholesterol, and increases in HDL cholesterol. BMI z-scores and cardiometabolic parameters partially regressed after treatment cessation but remained improved compared to baseline.

Conclusions:

AOMs demonstrate potential for weight management and cardiometabolic improvement in children with obesity, particularly among those with severe obesity and comorbidities, within real-world settings. However, the modest utilization rate highlights the need for improved accessibility and further real-world evidence to optimize treatment strategies for pediatric obesity.

2025-06-01·International Journal of Surgery

Glucagon-like-peptide-1 (GLP-1) receptor agonist use and the risk of pulmonary aspiration in patients undergoing surgery

Article

作者: Hur, Chin ; Matsuo, Koji ; Xu, Xiao ; Chen, Ling ; Wright, Jason D. ; Elkin, Elena B. ; Hershman, Dawn L.

Glucagon-like-peptide-1 (GLP-1) receptor agonists are approved for the treatment of type II diabetes mellitus and obesity. These agents slow gastric emptying and may increase the risk of pulmonary aspiration, particularly in patients undergoing elective surgery. We used a claims database to examine the association between perioperative GLP-1 receptor agonist use and the risk of pulmonary aspiration. A total of 392 065 patients including 15 745 (4.0%) who used GLP-1 receptor agonist who underwent elective surgery were identified. The rate of pulmonary aspiration was 0.8% in those who received GLP-1 receptor agonists versus 0.7% in those who had not (P = 0.61). After adjusting for other risk factors for aspiration, there was no association between GLP-1 agonist use and aspiration (OR = 1.07; 95% CI, 0.85–1.34).

项与 MET-097 相关的新闻（医药）

2025-06-14

·药明康德

一针持久降尿酸3-6个月的siRNA新药申报临床；默沙东口服降血脂多肽达3期临床终点…… | TIDES周报

近期，全球多肽和寡核苷酸（TIDES）领域迎来系列进展。Alnylam Pharmaceuticals公司的小干扰RNA（siRNA）疗法Amvuttra（vutrisiran）在欧盟获批新适应症。Apellis Pharmaceuticals公司与Sobi公司的双环肽疗法pegcetacoplan的3期临床试验结果积极，第26周时关键指标下降近70%。默沙东（MSD）用于治疗高脂血症的在研口服环肽疗法enlicitide decanoate的两项3期临床试验达到主要终点和所有关键次要终点。丽珠医药用于治疗痛风的siRNA疗法YJH-012的IND申请获中国国家药品监督管理局（NMPA）正式受理，该疗法单次给药有望实现3-6个月的持续降尿酸效果。Vutrisiran：在欧盟获批新适应症Alnylam Pharmaceuticals公司宣布，欧盟委员会（EC）已批准其siRNA疗法Amvuttra用于治疗伴有心肌病的转甲状腺素蛋白淀粉样变性（ATTR-CM）患者。根据新闻稿，这一批准使Amvuttra成为获得EC批准可用于治疗ATTR-CM及遗传性转甲状腺素蛋白介导（hATTR）淀粉样变性的多发性神经病（polyneuropathy）的首个RNAi疗法。此次批准主要基于关键3期HELIOS-B研究的积极结果。该研究为一项随机、双盲、安慰剂对照的多中心全球试验。分析显示，Amvuttra在总体和单药治疗人群中均达成所有10项预设的主要与次要终点，显著降低全因死亡与复发性心血管事件，同时改善6分钟步行距离、健康状态、生活质量（KCCQ评分）以及心力衰竭症状与严重程度（NYHA分级）。在总体人群中，与安慰剂相比，Amvuttra在主要复合终点（全因死亡和复发性心血管事件）方面实现了28%的风险降低。在一项预设的次要终点分析中，包括最长36个月的双盲期及6个月的开放标签延长期，该患者群体的死亡率显著下降了36%，进一步印证其临床益处。Pegcetacoplan：公布3期临床试验数据Apellis Pharmaceuticals公司与Sobi公司公布了其3期VALIANT研究开放标签期的新数据，该试验评估Empaveli（pegcetacoplan）在治疗C3肾小球病（C3G）及原发性免疫复合物性膜增生性肾小球肾炎（IC-MPGN）中的疗效与安全性。Empaveli是一款靶向C3补体蛋白的聚乙二醇化（PEGylated）双环肽疗法。双环肽分子集抗体、小分子药物及肽类的特性于一身，具有与抗体类似的亲和性和精确的靶向特异性；同时，由于它们分子量较小，使得其能够快速深入地渗透组织。此前，Empaveli已获FDA批准用于治疗阵发性睡眠性血红蛋白尿症（PNH）和由年龄相关性黄斑变性（AMD）引起的地图样萎缩（GA）。结果显示，与安慰剂相比，Empaveli在第26周实现了蛋白尿下降达68%，差异具有统计学意义。这一疗效在治疗持续一年后仍得以维持。同时，接受Empaveli治疗的患者在估算肾小球滤过率（eGFR）指标上显示出肾功能的持续稳定。Empaveli整体安全性良好，耐受性与既往研究结果一致，未发现新的安全性信号，支持其在该类补体介导性肾病中的持续开发潜力。美国FDA与欧洲药品管理局（EMA）正在对该药物用于肾病的监管申请进行审评。Enlicitide decanoate（MK-0616）：公布两项3期临床试验数据默沙东（MSD）公司宣布，其在研口服PCSK9抑制剂enlicitide decanoate（MK-0616）在三项3期临床试验中的前两项取得积极结果，显示该疗法能有效用于治疗正在接受降脂治疗（包括至少使用他汀类药物）的高脂血症成人患者。PCSK9是一种经验证用以降低低密度脂蛋白胆固醇（LDL-C）的靶标。然而，目前尚无口服PCSK9抑制剂可供医生和患者使用。Enlicitide decanoate是一种与PCSK9结合并抑制PCSK9与LDL受体相互作用的大环肽，旨在通过与目前获批的注射型PCSK9抑制剂相同的生物学机制降低LDL-C，但以每日片剂形式给药。根据新闻稿，enlicitide decanoate有望成为获美国FDA批准的首款口服PCSK9抑制剂。此次公布的结果显示，CORALreef HeFH和CORALreef AddOn试验均成功达到主要终点和所有关键次要终点。与安慰剂（CORALreef HeFH）或其他口服非他汀类药物（CORALreef AddOn）相比，enlicitide decanoate在降低患者的LDL-C水平方面具有统计学显著性和临床意义的改善。此外，在两项研究中使用该疗法患者的不良事件和严重不良事件（SAE）的发生率，与对照组相较在临床上无显著差异。MET-233i：公布1期临床试验数据Metsera公司公布了其超长效、每月皮下注射的胰淀素类似物MET-233i的1期临床试验的积极结果。在该研究中，接受MET-233i治疗的患者在第36天时实现了平均8.4%的安慰剂校正体重减轻效果。在临床试验中观察到MET-233i的半衰期长达19天，支持每月一次给药，并且耐受性良好，未出现安全性信号。此外，MET-233i经过工程优化，可以与Metsera公司的超长效GLP-1受体激动剂MET-097i在溶液中稳定共存（具有匹配的溶解参数和相似的观察半衰期）。MET-233i单药以及与MET-097i联用的临床研究目前正在进行中。Delpacibart braxlosiran（AOC 1020）：公布1/2期临床试验的新数据Avidity Biosciences公司公布了其用于治疗面肩肱型肌营养不良症（FSHD）的在研抗体寡核苷酸偶联物（AOC）delpacibart braxlosiran（del-brax）在临床1/2期试验FORTITUDE中的积极新数据。FSHD是由于DUX4基因异常表达所引起。DUX4蛋白的异常表达导致肌肉细胞基因表达的变化，造成FSHD患者肌肉功能的终身、渐进性丧失。根据新闻稿，del-brax是首个旨在治疗FSHD根本原因的在研AOC疗法，由一种专有的转铁蛋白受体1（TfR1）靶向单克隆抗体，与靶向DUX4 mRNA的siRNA偶联所组成。此次公布的结果显示，与安慰剂相比，在接受del-brax治疗的FSHD患者中观察到肌肉功能活动能力、肌肉力量和患者报告的结局（PROs）衡量的生活质量方面的改善，并且生物标志物出现了快速而显著的下降。安全性方面，del-brax表现出良好的长期安全性和耐受性，大多数不良事件为轻度或中度，无相关的严重不良事件，也没有停药事件。VCA-894A：首次人体试验完成首例患者给药Vanda Pharmaceuticals公司宣布，其反义寡核苷酸（ASO）疗法VCA-894A的首次人体临床试验已完成首例患者给药。VCA-894A是一种2'-O-甲氧基乙基（MOE）硫代磷酸寡核苷酸钠盐，特异性靶向IGHMBP2基因中一种剪接位点变体，该变体会导致2S型腓骨肌萎缩症（CMT2S）。YJH-012：IND申请获NMPA受理丽珠医药宣布，其1类创新药YJH-012的IND申请已于近日获NMPA正式受理。该药物是一款以GalNAc为递送系统的siRNA疗法，旨在精准递送siRNA至尿酸合成的主要场所——肝脏，降低关键致病蛋白的生成量，从源头上长效抑制尿酸生成，有望治疗痛风伴高尿酸血症。新闻稿指出，YJH-012单次给药即可实现3-6个月的持续降尿酸效果。此外，尿酸抑制平稳上升并长期维持，避免治疗初期尿酸急速下降将导致“溶晶反应”从而引发二次痛风，相对现有治疗药物，具备更好的治疗潜力。安全性方面，在临床前研究中，未观察到次黄嘌呤、IMP、AMP、GMP等关键嘌呤代谢物的异常升高，也未发现肝脏相关病理性改变，初步提示了良好的安全性特征。参考资料：[1] Metsera Announces Positive Phase 1 Data of First-in-Class Once-Monthly Amylin Candidate MET-233i. Retrieved June 13, 2025, from https://www.globenewswire.com/news-release/2025/06/09/3095726/0/en/Metsera-Announces-Positive-Phase-1-Data-of-First-in-Class-Once-Monthly-Amylin-Candidate-MET-233i.html[2] Avidity Biosciences Announces Positive Topline Phase 1/2 FORTITUDE™ Data Demonstrating Consistent Improvement Across Multiple Functional Measures Compared to Placebo in Del-Brax Treated FSHD Participants. Retrieved June 13, 2025, from https://www.prnewswire.com/news-releases/avidity-biosciences-announces-positive-topline-phase-12-fortitude-data-demonstrating-consistent-improvement-across-multiple-functional-measures-compared-to-placebo-in-del-brax-treated-fshd-participants-302476040.html[3] Merck Announces Positive Topline Results From the First Two Phase 3 CORALreef Trials Evaluating Enlicitide Decanoate for the Treatment of Adults With Hyperlipidemia. Retrieved June 9, 2025 from https://www.businesswire.com/news/home/20250609545552/en/Merck-Announces-Positive-Topline-Results-From-the-First-Two-Phase-3-CORALreef-Trials-Evaluating-Enlicitide-Decanoate-for-the-Treatment-of-Adults-With-Hyperlipidemia[4] 痛风1类新药丨丽珠医药 siRNA 药物 YJH-012 临床试验申请已获受理. Retrieved June 13, 2025, from https://mp.weixin.qq.com/s/FeBR-j9Oe0R4OcIyr8L3yA[5] Vanda Pharmaceuticals Announces First Patient Dosed in a Trial Evaluating VCA-894A in Charcot-Marie-Tooth disease Type 2S. Retrieved June 13, 2025, from https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-first-patient-dosed-in-a-trial-evaluating-vca-894a-in-charcot-marie-tooth-disease-type-2s-302477600.html[6] Apellis and Sobi Announce EMPAVELI® (pegcetacoplan) Showed Sustained Efficacy at One Year in Phase 3 Study for C3G and Primary IC-MPGN. Retrieved June 10, 2025 from https://www.globenewswire.com/news-release/2025/06/06/3095128/0/en/apellis-and-sobi-announce-empaveli-pegcetacoplan-showed-sustained-efficacy-at-one-year-in-phase-3-study-for-c3g-and-primary-ic-mpgn.html[7] Alnylam Receives European Commission Approval for AMVUTTRA® (vutrisiran) for the Treatment of ATTR Amyloidosis with Cardiomyopathy. Retrieved June 10, 2025 from https://www.businesswire.com/news/home/20250609199979/en/Alnylam-Receives-European-Commission-Approval-for-AMVUTTRA-vutrisiran-for-the-Treatment-of-ATTR-Amyloidosis-with-Cardiomyopathy[8] TransCon® hGH Boosted Treatment Benefits of TransCon® CNP in Children with Achondroplasia at Week 26 Interim Analysis of the Phase 2 COACH Trial. Retrieved June 13, 2025 from https://www.globenewswire.com/news-release/2025/06/09/3095728/0/en/index.html[9] Silence Therapeutics Presents Additional Phase 1 Data Highlighting Promise of Divesiran as the Potential First-in-Class siRNA Treatment for Polycythemia Vera. Retrieved June 13, 2025, from https://silence-therapeutics.com/investors/press-releases/press-releases-details/2025/Silence-Therapeutics-Presents-Additional-Phase-1-Data-Highlighting-Promise-of-Divesiran-as-the-Potential-First-in-Class-siRNA-Treatment-for-Polycythemia-Vera/default.aspx[10] Lembas Emerges from Stealth with Breakthrough Discovery in Natural GLP-1 for Weight Management. Retrieved June 13, 2025, from https://www.prnewswire.com/news-releases/lembas-emerges-from-stealth-with-breakthrough-discovery-in-natural-glp-1-for-weight-management-302478808.html免责声明：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：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3期siRNA临床结果临床申请

2025-06-09

·EndPoints

Metsera shares early data on anti-obesity amylin candidate

Metsera, which is attempting to make long-acting obesity and metabolic disease medicines, has shared its first clinical data as a recently minted public company. The New York-based biotech said Monday morning that its amylin analog met expectations in a Phase 1 trial. The experimental injectable, called MET-233i, led to a weight loss of as much as 8.4% at day 36 following administration of five weekly 1.2 mg doses. Metsera said there were no severe or serious adverse events and that gastrointestinal side effects in the multiple ascending dose part of the study were mild and dose-dependent. The goal is to have “placebo-like tolerability,” Metsera medical chief Steve Marso said in an interview. The Phase 1 drug is not Metsera’s most advanced candidate. That title belongs to a long-acting GLP-1 receptor agonist known as MET-097i, which is in Phase 2b. But the results are an important moment for the biotech’s efforts to compete against other amylin drugs and to develop a long-acting therapy. After the success of GLP-1 drugs, biopharma companies have rushed into the amylin space to find the next breakout obesity drug, with Lilly, Novo Nordisk, Roche , AbbVie and others all vying for a spot. With clinical data on both MET-097i and MET-233i now in hand, Metsera has shown that its peptide engineering platform “really delivers,” CEO Whit Bernard said in an interview with Endpoints News . The company expects results from a 12-week monotherapy study of MET-233i in “late 2025.” The biotech is also running a 12-week trial testing MET-233i co-administered with MET-0971i. Those data are slated for “early 2026,” the company said. Metsera went public in a $275 million IPO in late January. It’s one of the few biotechs of the past few years to still be trading $MTSR above its IPO price. Prior to listing on the Nasdaq, Metsera conducted two major financings, acquired UK biotech Zihipp, did a deal for oral medicines with South Korea-based D&D Pharmatech and inked a critical manufacturing accord with Amneal.

临床1期IPO临床2期临床结果

2025-06-04

·EndPoints

Lilly makes a move for long-acting incretins in tech deal with Swedish biotech

Eli Lilly has tapped Camurus in a deal worth up to $870 million for its drug delivery technology to develop four long-acting incretin candidates. The technology can be used on any of Lilly’s dual GLP-1/GIP receptor agonists as well as triple GLP-1/GIP/glucagon receptor agonists. There’s also the option to develop the tech with amylin receptor agonists, according to the Tuesday release. Lilly will pay the Swedish biotech $290 million in upfront, development, and regulatory milestone payments, and potentially another $580 million based on future sales milestones and tiered mid-single-digit royalties for the four products. Camurus’ stock was up 31% on the Swedish stock exchange on Wednesday morning. The biotech’s technology, dubbed FluidCrystal, allows the development of a lipid-based liquid that becomes a gel once injected into the body. The gel would then make way for the slow release of the active ingredient — in this case, an incretin — “from days to months,” the company said. Lilly has four potential assets that could be candidates for FluidCrystal, according to a Tuesday note from Jefferies analysts. The big pharma’s blockbuster drugs Zepbound and Mounjaro could be up for consideration, as well as two clinical assets: the GLP-1/GIP/glucagon agonist retatrutide and the amylin eloralintide, they added. There’s increasing interest in long-acting obesity drugs. Notably, Metsera recently reported that in a Phase 2 study, its long-acting injectable GLP-1 agonist MET-097i reduced mean body weight by 11.3% at three months. MET-097i has a half-life of over two weeks.

临床2期临床结果临床1期

100 项与 MET-097 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
2型糖尿病	临床2期	美国	Metsera, Inc.	2025-03-14
肥胖	临床2期	美国	Metsera, Inc.	2024-10-24

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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


NCT06712836 (BusinessWire) 人工标引	临床2期	超重 \| 肥胖	120	MET-097i	築膚醖鹽廠選鬱糧顧觸(襯選構壓範憲襯窪夢範) = Weight loss was dose-dependent, with substantial reductions in mean body weight of 11.3% (placebo-adjusted) and individual responses as high as ~20% in the 1.2mg dose cohort after 12 weekly doses. 範築齋網鑰餘觸觸醖製 (壓獵願壓鬱夢窪膚範夢 ) 更多	积极	2025-01-07
NCT06712836 (BusinessWire) 人工标引	临床2期	超重 \| 肥胖	120	Placebo		积极	2025-01-07
Biospace 人工标引	临床1期	超重 \| 肥胖	125	MET-097	築遞簾夢襯壓製憲鹽獵(觸網壓淵構壓襯餘範顧) = 簾範膚鏇遞襯廠襯製鏇鏇蓋顧壓觸繭範蓋鑰蓋 (壓蓋夢艱選鏇齋範膚顧 ) 更多	积极	2024-09-24