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.

NCT06712836

/ Active, not recruiting临床2期

A Phase 2b, Multi-Center, Randomized, Placebo-Controlled Double-Blind Study to Investigate the Safety and Efficacy of Once-Weekly MET097 in Participants with Obesity and Overweight (VESPER-1)

This study is designed to test how well MET097, an active drug, works to treat individuals with obesity or overweight when compared to placebo. MET097 or placebo will be given to individuals weekly for 28 weeks. If an individual is assigned to MET097 they will receive one of four different dose levels.

开始日期2024-10-24

申办/合作机构

Metsera, Inc.

100 项与 GLP-1 receptor agonist (Metsera) 相关的临床结果

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100 项与 GLP-1 receptor agonist (Metsera) 相关的转化医学

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100 项与 GLP-1 receptor agonist (Metsera) 相关的专利（医药）

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项与 GLP-1 receptor agonist (Metsera) 相关的文献（医药）

2025-05-01·Molecular Metabolism

Semaglutide and bariatric surgery induce distinct changes in the composition of mouse white adipose tissue

Article

作者: Seeley, Randy J ; Rosen, Evan D ; Gulko, Anton ; Bozadjieva-Kramer, Nadejda ; Jacobs, Christopher ; Essene, Adam L ; Tsai, Linus T ; Emont, Margo P ; Nagesh, Soumya

Adipose tissue is a central player in energy balance and glucose homeostasis, expanding in the face of caloric overload in order to store energy safely. If caloric overload continues unabated, however, adipose tissue becomes dysfunctional, leading to systemic metabolic compromise in the form of insulin resistance and type 2 diabetes. Changes in adipose tissue during the development of metabolic disease are varied and complex, made all the more so by the heterogeneity of cell types within the tissue. Here we present detailed comparisons of atlases of murine WAT in the setting of diet-induced obesity, as well as after weight loss induced by either vertical sleeve gastrectomy (VSG) or treatment with the GLP-1 receptor agonist semaglutide. We focus on identifying populations of cells that return to a lean-like phenotype versus those that persist from the obese state, and examine pathways regulated in these cell types across conditions. These data provide a resource for the study of the cell type changes in WAT during weight loss, and paint a clearer picture of the differences between adipose tissue from lean animals that have never been obese, versus those that have.

2025-05-01·INTERNATIONAL IMMUNOPHARMACOLOGY

A novel dual CCK/ GLP-1 receptor agonist ameliorates cognitive impairment in 5 × FAD mice by modulating mitophagy via the PINK1/Parkin pathway

Article

作者: Hölscher, Christian ; Zhang, Zhenqiang ; Zhang, Zijuan ; Hao, Li ; Kang, Yuhan ; Luo, Rihong ; Ma, He

To date, no therapeutic drugs available on the market can effectively reverse the progression of Alzheimer's disease (AD). Although Glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) and Cholecystokinin (CCK) RAs have shown some promise in AD research, little is known about the neuroprotective effects of a novel dual CCK/GLP-1 RA in AD. This study sought to examine the effects of the novel dual CCK/GLP-1 RA on cognitive performance in an AD mouse model and to explore the associated mechanisms. Our findings indicate that dual CCK/GLP-1 RA improved cognitive deficits, reduced amyloid-beta (Aβ) accumulation, and alleviated mitochondrial damage in 5 × FAD mice by inducing mitophagy. In an in vitro model of AD cells induced by Aβ, CCK/GLP-1 RA could exert neuroprotective effects by regulating PINK1/Parkin-mediated mitophagy. These data reveal for the first time that the new CCK/GLP-1 RA modulates mitophagy via PINK1/Parkin pathway and enhances cognitive function in the 5 × FAD animal model. Moreover, the performance of the CCK/GLP-1 RA in certain indicators was superior to that of GLP-1 analogue liraglutide, suggesting that it may represent a more promising therapeutic option for AD.

2025-05-01·Lancet Diabetes & Endocrinology

GLP-1 receptor agonists in kidney transplant recipients with pre-existing diabetes: a retrospective cohort study

Article

作者: Ali, Nicole M ; Gujral, Akash ; Lonze, Bonnie E ; Metoyer, Garyn T ; Chen, Yusi ; Segev, Dorry L ; McAdams-DeMarco, Mara ; Lentine, Krista L ; Ren-Fielding, Christine J ; Weintraub, Michael ; Orandi, Babak J ; Bae, Sunjae ; Li, Yiting ; Lofton, Holly

BACKGROUND:

Given the cardiovascular, renal, and survival benefits of GLP-1 receptor agonists for diabetes, these agents could be effective among kidney transplant recipients. However, kidney transplant recipients are distinct from GLP-1 receptor agonist trial participants, with longer diabetes duration and severity, greater end-organ damage, increased cardiovascular risk, and multimorbidity. We examined GLP-1 receptor agonist real-world effectiveness and safety in kidney transplant recipients with diabetes.

METHODS:

This USA-based retrospective cohort study included kidney transplant recipients with type 2 diabetes at transplantation and Medicare as their primary insurance from a national registry linked with Medicare claims. Post-transplantation GLP-1 receptor agonist use was identified through Medicare claims. Death-censored graft loss was estimated using the Fine-Gray sub-distribution hazard model and extended Cox models were used for mortality and safety endpoints. Models incorporated inverse probability of treatment weights. To further test whether bias could affect the main results, a cohort was created in which each GLP-1 receptor agonist user was matched with a kidney transplant recipient who had not started a GLP-1 receptor agonist, was alive with a functioning graft, and had accrued the same amount of post-transplant survival time.

FINDINGS:

Between Jan 1, 2013 and Dec 31, 2020, we identified 44 536 first time kidney transplant recipients with Medicare as primary payer in the 6 months before and at transplantation. 24 192 patients were excluded as they did not have type 2 diabetes. 2328 patients were ineligible (1916 had missing values and 412 used GLP-1 receptor agonists before transplantation). The primary cohort thus consisted of 18 016 kidney transplant recipients with diabetes. Of these patients, 1969 (10·9%) had at least one GLP-1 receptor agonist prescription filled post-transplant. Compared with patients who had not received a GLP-1 receptor agonist, GLP-1 receptor agonist users were younger (median age at transplant 57 years [IQR 49-64] vs 60 years [51-66], p<0·0001) and more likely to be female (786 [39·9%] vs 5645 [35·2%], p<0·0001). Among GLP-1 receptor agonist users, 552 [28·0%] were non-Hispanic White, 703 [35·7%] were non-Hispanic Black, and 568 [28·8%] were Hispanic. The 5-year unadjusted cumulative incidence of death-censored graft loss from a cohort matched on survival time before GLP-1 receptor agonist initiation was 6·0% for GLP-1 receptor agonist users and 10·7% for non-users (Gray's test p=0·004). The 5-year unadjusted cumulative incidence for mortality from a cohort matched on survival time before GLP-1 receptor agonist initiation was 17·0% for GLP-1 receptor agonist users and 25·8% for non-users (log-rank p=0·0006). The 5-year unadjusted cumulative incidence for mortality was 13·5% for GLP-1 receptor agonist users and 19·9% for non-users (log-rank p<0·0001). GLP-1 receptor agonist use was associated with a 49% lower incidence of death-censored graft loss (adjusted subhazard ratio [aSHR] 0·51, 95% CI 0·36-0·71; p=0·0001) and 31% lower mortality (adjusted hazard ratio [aHR] 0·69, 95% CI 0·55-0·86; p=0·001). Inferences were robust when matched on survival time (death-censored graft loss aSHR 0·53, 95% CI 0·37-0·75; p=0·0005; mortality aHR 0·70, 95% CI 0·55-0·88; p=0·003). Safety endpoints were rare and not associated with GLP-1 receptor agonists, with the exception of diabetic retinopathy (aHR 1·49, 1·11-2·00; p=0·008).

INTERPRETATION:

GLP-1 receptor agonists were associated with better graft and patient survival. Clinical trials are needed to confirm these findings.

FUNDING:

National Institutes of Health.

项与 GLP-1 receptor agonist (Metsera) 相关的新闻（医药）

2025-04-23

·PRNewswire

ProRx Pharma Continues to Expand Preventative Health Portfolio with Six New Products

Expanded Product Line Targets Growing Demand for Proactive Wellness Solutions in Clinics, Med Spas, 503A Pharmacies, and Telehealth Practices Across the United States WEST PALM BEACH, Fla. and EXTON, Pa., April 23, 2025 /PRNewswire/ -- ProRx Pharma, the leading health and wellness 503B outsourcing facility, today announced the addition of six new injectable products designed to support the rising demand for preventive care: Gonadorelin, Liraglutide, Vitamin D3, and Phenylephrine HCl as well as two Tri-Mix injection options. These high-quality standalone injectables are now available for bulk shipping to licensed medical facilities in 26 states and for direct-to-consumer shipping nationwide through ProRx's growing network of 503A pharmacies, clinics, med spas and telehealth providers. "Patients are taking charge of their health like never before," said Kurt Lunkwitz, chief operating officer at ProRx. "Physicians are following suit, integrating wellness therapies into their practices to meet the demand for more proactive, functional care. This trend is only going to continue. The continued expansion of our health and wellness line is a direct response—and a step toward making preventative health more accessible and streamlined." What's New: The Products Each of the six new offerings comes with its own National Drug Code (NDC) number and an extended Beyond Use Date (BUD), providing both flexibility and longer shelf life for providers: Gonadorelin ( 1 mg/mL, 6 mg / 6 mL vial ) A gonadotropin-releasing hormone agonist which is used in fertility medicine and to treat amenorrhea and hypogonadism. Gonadorelin may promote testosterone production; may support fertility, libido, and hormonal balance. Liraglutide ( 0.75 mg, 1 mg, 2 mg, 3 mg [custom dosing] ) A powerful GLP-1 receptor agonist for weight and blood-sugar management. Liraglutide may aid in weight loss, appetite suppression, and blood-sugar control. Vitamin D3 ( 50,000 IU/mL, 5 mL vial ) A high-dose solution for those with critically low vitamin D levels. Vitamin D3 may support immune function, bone health, mood, and Vitamin D repletion. Tri-Mix #1 ( 30 mg / 1 mg / 10 mcg/mL, 5 mL vial ) The first of two strength offerings for erectile dysfunction (ED) therapy. Tri Mix #1 may improve erectile response through smooth muscle relaxation and blood flow. Tri-Mix #2 ( 30 mg / 2 mg / 20 mcg/mL, 5 mL vial ) A stronger ED therapy offering. Tri-Mix #2, may provide more ED support for patients needing increased vasodilation. Phenylephrine HCl ( 0.1% 2 mL vial) A critical safety solution for patients using Tri-Mix therapies. Phenylephrine HCl may reverse prolonged erection or priapism due to ED therapy. The introduction of these six new products comes on the heels of ProRx announcing its first four preventative-care offerings the first week of April: Sermorelin, NAD+, Glutathione and MIC/B6/B12. Exclusive Launch at A4M Conference ProRx is showcasing its full line of preventative-care products at the A4M 33rd Annual Spring Conference taking place April 24-26 in West Palm Beach, Florida. At Booth 527, attendees will get an exclusive first look at all 10 products in the new product line and be able to speak with ProRx's experts about the company's compliance and quality-assurance programs. About ProRx Pharma ProRx Pharma is an FDA-registered cGMP facility focused on providing essential compounded medications to meet the need for medications on the FDA drug shortage and bulks list with an emphasis on preventative health. The company produces products and formulations for medical institutions, physician offices, and 503A pharmacies, with a specialization in producing high-quality products to ensure patients have access to the medications they need during critical shortages. For more information, visit SOURCE ProRx Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准

2025-04-21

·PipelineReview

Coya Therapeutics Announces Publication of GLP-1/LD IL-2 Combination Biologic (COYA 303) Demonstrating Synergistic Enhancement of Regulatory T Cell Function and Protection Against Treg Apoptosis (Cell Death)

COYA 303 is an investigational biologic combination of COYA 301, Coya’s low-dose interleukin 2 (LD IL-2) and a GLP-1 receptor agonist (GLP-1RA), designed to deliver a multi-targeted immunomodulatory therapeutic in autoimmune and neurodegenerative diseases COYA 303 produced a statistically significantly higher Treg suppressive effect on pro-inflammatory myeloid cells and enhanced Treg survival in in vitro human immune cells, compared to the individual components – LD IL-2 and GLP-1RA HOUSTON, TX, USA I April 21, 2025 I Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, today announced publication of the results of a study designed to evaluate the effects of COYA 303 (LD IL-2 and GLP-1RA), Coya’s investigational biologic combination to suppress pro-inflammatory myeloid cells, enhance Treg suppressive function, and modulate T cell proliferation, in an in vitro system of human immune cells obtained from healthy donors. The research was conducted at the Houston Methodist Research Institute and was led by Dr. Aaron Thome and Dr. Stan Appel. The research article has been published in the Journal NeuroImmune Pharmacology and Therapeutics and can be accessed here . Dr. Arun Swaminathan, Coya’s Chief Executive Officer, stated, “We believe COYA 303 could offer a differentiated and synergistic approach to addressing multiple conditions, including in neurodegenerative conditions such as Alzheimer’s Disease, in which GLP-1 RAs have recently shown promise. We believe the potential of this proprietary combination could lead to value-creating opportunities and may open up a new avenue of research within the GLP-1RA drug class.” LD IL-2 preferentially binds the IL-2 receptor alpha, which is predominantly expressed on Tregs to enhance their anti-inflammatory suppressive function. Treg dysfunction has been well documented in several autoimmune and neurodegenerative diseases characterized by persistent inflammation. GLP-1RAs also exhibit several immune-modulating effects, with myeloid cells and regulatory subsets, such as Tregs, expressing a large concentration of GLP-1 receptors. Although increased Treg numbers and enhanced suppressive function are seen with LD IL-2 treatment, their longevity and suppressive function can be limited by the effects of pronounced and sustained inflammatory environments. Therefore, a combination therapy approach that dampens the inflammatory microenvironment while enhancing Treg survival and function may provide synergistic anti-inflammatory therapeutic effects. Dr. Fred Grossman, Coya’s Chief Medical Officer commented, “ We believe the encouraging results of this study provide support for our multi-targeted combination approach as a potentially viable treatment option for serious and life-threatening conditions of high unmet need driven by chronic inflammation and Treg dysfunction, for which currently available treatments provide limited benefits.” Summary of Study Results Following pro-inflammatory activation of myeloid cells co-cultured with Tregs, the addition of COYA 301 (LD IL-2) alone enhanced Treg suppressive function by 15%. Similarly, when GLP-1RA alone was added to the system, Treg suppressive function increased by 20%. In contrast, when COYA 303 was added to the cell system a statistically significant increase in Treg suppressive function of 42% (p < 0.001) was observed, when compared to the increase observed with each of the single agents. Consistent with these results, treatment with COYA 303 promoted Treg survival by modulating the apoptotic pathway. COYA 303 significantly reduced BAX transcript levels during prolonged incubation (p < 0.01). These findings suggest a direct effect of COYA 303 supporting Treg survival through the inhibition of Treg apoptosis. These data show that the combination approach of COYA 303 enhances Treg suppressive function in highly inflammatory microenvironments, while also promoting Treg survival by preventing apoptosis. Additional details and results of the research study can be found here . About Coya Therapeutics, Inc. Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions, including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. For more information about Coya, please visit www.coyatherapeutics.com SOURCE: Coya Therapeutics

临床结果免疫疗法细胞疗法

2025-04-15

·PRNewswire

Parker Waichman LLP Files One of the First NAION Eye Injury Cases against Novo Nordisk in the Superior Court of New Jersey, Middlesex County

PORT WASHINGTON, N.Y., April 15, 2025 /PRNewswire/ -- Parker Waichman LLP, a nationally recognized law firm dedicated to representing victims of defective drugs and devices, recently filed a lawsuit against Novo Nordisk on behalf of a New Jersey based Plaintiff diagnosed with non-arteritic anterior ischemic optic neuropathy (NAION). NAION, a debilitating eye condition, is linked to the active ingredient, semaglutide, in Ozempic and Wegovy. The case is now pending in the Superior Court of New Jersey, Middlesex County. Parker Waichman LLP is urging individuals who have suffered serious eye injuries after taking these widely prescribed GLP-1 receptor agonist medications to contact the firm for a free case review. These medications, originally developed to treat Type 2 diabetes, have surged in popularity for weight loss. However, recent studies have uncovered a disturbing link between semaglutide (Ozempic/Wegovy) and NAION, a condition that causes permanent vision loss by cutting off blood flow to the optic nerve. Patients who took these drugs have reported sudden blindness, optic nerve damage, and other irreversible complications, raising concerns about the failure of drug manufacturers to warn consumers and medical professionals about these risks. A 2025 study published in JAMA Ophthalmology examined nine patients who developed optic nerve disorders after using GLP-1 medications, with the majority suffering from NAION-like symptoms. Additional research from Harvard's Mass Eye and Ear Institute found that diabetic users of semaglutide were four times more likely to develop NAION, while non-diabetic users taking the drug for weight loss faced a sevenfold increased risk. Despite growing scientific evidence, Novo Nordisk continues to downplay the dangers associated with these medications, failing to include adequate warnings about the risk of permanent blindness. Parker Waichman LLP Fighting for Victims Nationwide "NAION is a devastating, permanent eye injury. Studies from multiple, reputable institutions, have shown a statistically significant relationship between semaglutide (the active ingredient in Ozempic) and NAION. Despite this evidence, Novo Nordisk continues to deny reality by failing to warn consumers and medical professionals about this horrific injury and must be held accountable," said Jason S. Goldstein, Senior Litigation Counsel at Parker Waichman LLP. Parker Waichman LLP is currently accepting cases nationwide for individuals who have suffered vision loss, blindness, or serious optic nerve damage after taking Ozempic or Wegovy. Victims may be entitled to compensation for medical expenses, lost wages, pain and suffering, and other damages. Free Case Review for Affected Individuals If you or a loved one experienced sudden vision loss, blindness, or optic nerve damage after using Ozempic or Wegovy, you may have a legal claim against the drug manufacturers. Parker Waichman LLP is offering free, no-obligation case evaluations to help victims understand their rights and pursue justice. Contact Parker Waichman LLP Today For a free consultation, call 1-800-YOUR-LAWYER (1-800-968-7529) or visit YourLawyer.com to learn more about your legal options and how to protect your rights. About Parker Waichman LLP Parker Waichman LLP is a nationally recognized law firm dedicated to fighting for victims of defective drugs, dangerous products, accidents, and corporate negligence. With a proven track record of holding pharmaceutical companies accountable, the firm has secured billions in settlements and verdicts for injured clients. Media Contact: Parker Waichman LLP Phone: 1-800-YOUR-LAWYER (1-800-968-7529) Website: SOURCE Parker Waichman LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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100 项与 GLP-1 receptor agonist (Metsera) 相关的药物交易

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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	積廠繭窪願選壓鹽積醖(顧窪淵構憲鑰鹹顧遞鏇) = 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. 鑰觸窪鹹鏇鹽醖積齋醖 (淵夢構範獵壓網醖範鏇 ) 更多	积极	2025-01-07
				Placebo
Biospace 人工标引	临床1期	超重 \| 肥胖	125	MET-097	艱鏇膚顧衊窪蓋膚夢窪(醖憲構齋窪選積廠觸製) = 壓齋鏇醖構窪遞憲範觸選衊餘廠憲範願選糧鏇 (壓築糧簾鬱繭選衊築築 ) 更多	积极	2024-09-24
RF28 \| PSUN182 (ENDO2022)	N/A	胰腺炎	161	GLP-1RA Therapy	顧簾鏇醖淵積蓋艱顧襯(醖艱艱醖選構艱製夢餘) = 範構獵壓糧鏇簾齋築齋窪艱繭艱艱範夢壓鑰顧 (顧齋鏇遞製艱遞醖構範 ) 更多	积极	2022-11-01
EASD2019	N/A	代谢综合征 \| 2型糖尿病	-	GLP-1 receptor (Patients prior to RYGB surgery)	廠窪壓築鏇淵餘獵願廠(築築鏇窪鏇構齋鑰襯夢) = 艱構鏇蓋觸鏇鏇遞鬱範鑰鑰鏇築糧鹹簾窪鹽構 (鏇衊範廠膚齋遞遞遞觸, 5) 更多	-	2019-09-18
				GLP-1 receptor (Patients one year after RYGB surgery)	廠窪壓築鏇淵餘獵願廠(築築鏇窪鏇構齋鑰襯夢) = 憲鹹觸壓鏇艱製積齋願鑰鑰鏇築糧鹹簾窪鹽構 (鏇衊範廠膚齋遞遞遞觸, 3) 更多