Obesity Startup Metsera Shares Rise on Early-Stage Trial Results
Metsera Inc. 's shares jumped after the obesity startup shared better-than-expected data on a weight-loss shot that would allow patients to go from weekly to monthly dosing.
In a small, early-stage trial, Metsera's drug — called MET-233i — helped patients shed up to 8.4% of their weight in 36 days, the company said in a statement. The drug also stayed around in the body longer, meaning it has the potential to be taken less frequently than shots made by Novo Nordisk A/S and Eli Lilly & Co.
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Yahoo
28 minutes ago
- Yahoo
Metsera Announces Positive Phase 1 Data of First-in-Class Once-Monthly Amylin Candidate MET-233i
Placebo-subtracted mean weight loss up to 8.4% at Day 36 19-day observed half-life supports once-monthly dosing as monotherapy and potential first-in-category monthly GLP-1 + Amylin combination Well-tolerated with no safety signals Company to host conference call and webcast today at 8:00 A.M. ET NEW YORK, June 09, 2025 (GLOBE NEWSWIRE) -- Metsera, Inc. (Nasdaq: MTSR), today announced positive topline data from the Phase 1 clinical trial of MET-233i, an ultra-long acting amylin analog engineered for class-leading durability, potency, and combinability with Metsera's fully-biased monthly GLP-1 receptor agonist candidate, MET-097i. In the study, MET-233i demonstrated up to 8.4% mean placebo-subtracted weight loss at Day 36, a 19-day observed half-life supporting once-monthly dosing, and a favorable tolerability profile with no safety signals. 'We are excited by these impressive results from MET-233i, which demonstrate exceptional efficacy with no safety signals, and enable the potential first monthly multi-NuSH combination,' said Steve Marso, M.D., Chief Medical Officer of Metsera. 'We observed five-week body weight loss comparable to that of leading GLP-1-based medicines, and we identified efficacious starting doses with placebo-like tolerability. These data position MET-233i as a potential best-in-class amylin and support a category-leading profile in combination with MET-097i.' The randomized, placebo-controlled, double-blind Phase 1 trial was designed to evaluate the pharmacokinetics, efficacy, and safety of subcutaneous MET-233i in 80 participants with overweight or obesity without type 2 diabetes. MET-233i was evaluated at single doses from 0.15 mg to 2.4 mg, and multiple doses from 0.15 mg to 1.2 mg given once weekly over five weeks without titration. The trial population was broadly balanced in gender between MET-233i and placebo and had a mean baseline body mass index of approximately 32. Topline results from the Phase 1 trial include: Dose-linear pharmacokinetics with an observed half-life of 19 days from dose to 50% of Cmax. This represents the most durable pharmacokinetic profile of any known amylin analog and supports the potential for once-monthly dosing with simplified titration. MET-233i's exposure profile after multiple doses matched that of MET-097i, supporting combinability as a potential first-in-category once-monthly multi-NuSH combination. These data further substantiate HALO™, Metsera's proprietary, novel peptide stabilization and lipidation platform technology. Body weight loss up to 8.4%. Body weight loss was dose-dependent, ranging up to a placebo-subtracted mean of 8.4% at Day 36 after five weekly doses of 1.2 mg, with individual responses as high as 10.2%. In the single ascending dose (SAD) portion of the trial, substantial weight loss was maintained more than four weeks after dosing, supported by the ultra-long pharmacokinetics observed for MET-233i. Favorable tolerability results. Gastrointestinal adverse events in the multiple ascending dose (MAD) portion of the trial were all mild, dose-dependent, and primarily confined to the first week of dosing, implying rapid onset of tolerance despite a three-fold accumulation of exposure over five weeks. Anticipated starting doses of 0.15 mg and 0.3 mg demonstrated tolerability results comparable to placebo in both the SAD and the MAD portions of the trial. No safety signals. There were no severe or serious adverse events observed in the SAD or MAD portion of the trial to date. 'Amylin agonism has emerged as a central therapeutic mechanism for metabolic diseases, but candidates in development have been limited to weekly dosing,' said Professor Carel le Roux, Director of the Metabolic Medicine Group and Chair in Experimental Pathology at University College Dublin. 'The durability and efficacy of MET-233i in this trial, along with its combinability with Metsera's GLP-1 RA, make it the potential first monthly multi-NuSH combination candidate for patients seeking greater levels of well-tolerated weight loss with a more convenient dosing schedule.'Next StepsBased on these positive topline data, Metsera is rapidly advancing MET-233i as a monotherapy and in combination with MET-097i: An ongoing monotherapy trial evaluates 12 weekly doses of MET-233i with dose titration, followed by an exposure-matched monthly dose at week 13. Topline data from this trial are expected in late 2025. Metsera has extended an ongoing co-administration trial of MET-233i and MET-097i to twelve weeks, with topline data expected by year-end 2025 or early 2026. The Company also expects to report topline clinical data from its ultra-long acting GIP receptor agonist, MET-034i, in combination with MET-097i, in late 2025. We anticipate that MET-034i will be the third peptide engineered with Metsera's HALO™ platform to enter clinical Call and Webcast InformationMetsera will host a conference call and webcast today, June 9, 2025, at 8:00 A.M. Eastern Time to discuss the Phase 1 clinical trial of MET-233i. A live webcast of the call and a replay will be available on the Events page in the Investors & News section of the Metsera website at To access the call by phone, participants should visit this link to receive dial-in details: About MET-233i MET-233i is an ultra-long acting, subcutaneously injectable monthly amylin analog engineered for class-leading durability, potency, and combinability in solution with Metsera's fully-biased, ultra-long acting GLP-1 RA candidate MET-097i, with matched solubility parameters and observed half-lives. MET-233i is being explored in clinical studies as a monotherapy and in combination with MET-097i. Metsera is developing the combination of MET-233i and MET-097i via the FDA biologic pathway with the intent to pursue the combination's regulatory approval in the United States under a Metsera's HALO™ peptide stabilization and lipidation platformHALO™ is Metsera's novel peptide stabilization and lipidation platform technology that enables peptides to bind simultaneously to albumin and to a drug target, designed to facilitate a half-life approaching that of albumin and exceeding that of other NuSH peptides. This ultra-long half-life may enable monthly dosing, improved tolerability, and improved Metsera, is a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases. Metsera is advancing a broad portfolio of oral and injectable incretin, non-incretin and combination therapies with potential best-in-class profiles to address multiple therapeutic targets and meet the future needs of a rapidly evolving weight loss treatment landscape. Metsera was founded in 2022 and is based in New York City. For more information, please visit us at and follow us on LinkedIn and X. Metsera may use its website as a distribution channel of material information about the Company. Financial and other important information regarding the Company is routinely posted on and accessible through the Investors & News section of its website at In addition, you may sign up to automatically receive email alerts and other information about the Company by using the 'Email Alerts' option on the Investors & Media page and submitting your email address. Forward Looking StatementsThis press release includes 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to the timelines, design and results of the Company's clinical trials and data releases; the Company's product candidate pipeline and milestone events; potential benefits of treatment with the Company's product candidates; and anticipated market opportunity and strategy. When used herein, words including 'anticipate,' 'believe,' 'can,' 'continue,' 'could,' 'designed,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'intend,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. All forward-looking statements are based upon the Company's current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, our limited operating history; our ability to generate revenue or become profitable; failure to obtain additional capital when needed on acceptable terms or at all; raising additional capital may cause dilution to our stockholders or require us to relinquish rights to our technologies or product candidates; our dependence on the success of our product candidates; risks associated with preclinical and clinical development; difficulties or delays in the commencement or completion, or the termination or suspension, of clinical trials; our ability to timely enroll patients in our clinical trials; if our current or future product candidates are associated with side effects, adverse events or other properties or safety risks; risks associated with the regulatory approval processes of the FDA and comparable foreign authorities; risks associated with conducting clinical trials and preclinical studies outside of the United States; our reliance on third parties to conduct clinical trials and preclinical studies; our reliance on third parties for the manufacture and shipping of our product candidates; risks associated with our license and collaboration agreements and future strategic alliances; significant competition in our industry; product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated; our success is dependent on our ability to attract and retain highly qualified management and other clinical and scientific personal; if we or our licensors are unable to obtain, maintain, defend and enforce patent or other intellectual property protection for our current or future product candidates or technology; risks associated with our common stock and the other important factors discussed under the caption 'Risk Factors' in its filings with the Securities and Exchange Commission, including in its Annual Report on Form 10-K for the year ended December 31, 2024 and its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which are accessible on the SEC's website at and the Investors section of the Company's website at Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause the Company's views to change. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release. Contact:Jono EmmettMetseramedia@
Associated Press
an hour ago
- Associated Press
Georgia's experience raises red flags for Medicaid work requirement moving through Congress
ATLANTA (AP) — Georgia's experiment with a work requirement for Medicaid offers a test of a similar mandate Republicans in Congress want to implement nationally, and advocates say the results so far should serve as a warning. Just days shy of its two-year anniversary, the Georgia Medicaid program is providing health coverage to about 7,500 low-income residents, up from 4,300 in the first year, but far fewer than the estimated 240,000 people who could qualify. The state had predicted at least 25,000 enrollees in the first year and nearly 50,000 in the second year. Applicants and beneficiaries have faced technical glitches and found it nearly impossible at times to reach staff for help, despite more than $50 million in federal and state spending on computer software and administration. The program, dubbed Georgia Pathways, had a backlog of more than 16,000 applications 14 months after its July 2023 launch, according to a renewal application Georgia submitted to the Trump administration in April. 'The data on the Pathways program speaks for itself,' said Laura Colbert, executive director of Georgians for a Healthy Future, an advocacy group that has called for a broader expansion of Medicaid without work requirements. 'There are just so many hurdles at every step of the way that it's just a really difficult program for people to enroll in and then to stay enrolled in too.' Georgia's rules A tax and spending bill backed by President Donald Trump and Republican lawmakers that passed the U.S. House in May would require many able-bodied Medicaid enrollees under 65 to show that they work, volunteer or go to school. The bill is now in the Senate, where Republicans want significant changes. Pathways requires beneficiaries to perform 80 hours a month of work, volunteer activity, schooling or vocational rehabilitation. It's the only Medicaid program in the nation with a work requirement. But Georgia recently stopped checking each month whether beneficiaries were meeting the mandate. Colbert and other advocates view that as evidence that state staff was overburdened with reviewing proof-of-work documents. Fiona Roberts, a spokeswoman for the state Department of Community Health, said Gov. Brian Kemp has mandated that state agencies 'continually seek ways to make government more efficient and accessible.' Georgia's governor defends Pathways The governor's office defended the enrollment numbers. Kemp spokesman Garrison Douglas said the early projections for Pathways were made in 2019, when the state had a much larger pool of uninsured residents who could qualify for the program. In a statement, Douglas credited the Republican governor with bringing that number down significantly through 'historic job growth,' and said the decline in uninsured residents proved 'the governor's plan to address our healthcare needs is working.' For BeShea Terry, Pathways was a 'godsend.' After going without insurance for more than a year, Terry, 51, said Pathways allowed her to get a mammogram and other screening tests. Terry touts Pathways in a video on the program's website. But in a phone interview with The Associated Press, she said she also experienced problems. Numerous times, she received erroneous messages that she hadn't uploaded proof of her work hours. Then in December, her coverage was abruptly canceled — a mistake that took months of calls to a caseworker and visits to a state office to resolve, she said. 'It's a process,' she said. 'Keep continuing to call because your health is very important.' Health advocates say many low-income Americans may not have the time or resources. They are often struggling with food and housing needs. They are also more likely to have limited access to the internet and work informal jobs that don't produce pay stubs. Republican lawmakers have promoted work requirements as a way to boost employment, but most Medicaid recipients already work, and the vast majority who don't are in school, caring for someone, or sick or disabled. Kemp's administration has defended Pathways as a way to transition people to private health care. At least 1,000 people have left the program and obtained private insurance because their income increased, according to the governor's office. After a slow start, advertising and outreach efforts for Pathways have picked up over the last year. At a job fair in Atlanta on Thursday, staff handed out information about the program at a table with mints, hand sanitizer and other swag with the Pathways' logo. A wheel that people could spin for a prize sat on one end. Since Pathways imposed the work requirement only on newly eligible state residents, no one lost coverage. The Arkansas experiment That's a contrast with Arkansas, where 18,000 people were pushed off Medicaid within the first seven months of a 2018 work mandate that applied to some existing beneficiaries. A federal judge later blocked the requirement. The bill that passed the U.S. House would likely cause an estimated 5.2 million people to lose health coverage, according to an analysis from the nonpartisan Congressional Budget Office released Wednesday. Arkansas Republican Gov. Sarah Huckabee Sanders has proposed reviving the work mandate but without requiring people to regularly report employment hours. Instead, the state would rely on existing data to determine enrollees who were not meeting goals for employment and other markers and refer those people to coaches before any decision to suspend them. Arkansas is among at least 10 states pursuing work requirements for their Medicaid programs separate from the effort in Congress. Republican state Sen. Missy Irvin said Arkansas' new initiative aims to understand who the beneficiaries are and what challenges they face. 'We want you to be able to take care of yourself and your family, your loved ones and everybody else,' Irvin said. 'How can we help you? Being a successful individual is a healthy individual.' ___ Associated Press writers Jonathan Mattise in Nashville, Tennessee, Andrew DeMillo in Little Rock, Arkansas, and Geoff Mulvihill in Philadelphia contributed to this report.
Forbes
an hour ago
- Forbes
Health Insurers Call Out Trump On Promise To Not Cut Seniors' Medicare
The nation's health insurance companies say legislation wending its way through the Republican-controlled Congress would break a promise by Donald Trump and the GOP not to cut Medicare benefits to seniors. It's the latest part of the healthcare industry to fight back against proposed federal cuts in healthcare benefits to millions of Americans. Already, physicians led by the American Medical Association have launched an ad campaign targeting U.S. Senators in an effort to thwart the budget legislation. Legislation known as the 'One Big Beautiful Bill Act' that narrowly passed the Republican-controlled U.S. House of Representatives two weeks ago would reduce federal Medicaid spending by $793 billion and increase the number of uninsured by 7.8 million, a KFF analysis shows. But the powerful lobby, America's Health Insurance Plans (AHIP) said Medicare, too, would be cut and raise costs on millions of seniors. AHIP's members include some of the nation's largest health insurers, including Elevance Health, Humana, CVS Health's Aetna and an array of Blue Cross and Blue Shield plans. These health insurers, including UnitedHealth Group's UnitedHealthcare, provide health benefits to more than half of the nation's eligible seniors through privatized coverage known as Medicare Advantage. The plans contract with the federal government to provide traditional coverage available in traditional Medicare plus extra benefits and services to seniors, such as disease management and nurse help hotlines with some also offering vision, dental care and wellness programs. 'The President and Congressional leaders made a clear promise to seniors that there would be no cuts to Medicare as part of the budget reconciliation legislation," AHIP President and CEO Mike Tuffin said Monday. 'Last-minute attempts to cut Medicare Advantage to fund other priorities would directly undermine that promise and lead to higher costs and reductions in benefits for more than 34 million seniors,' Tuffin said. "We oppose cuts to Medicare Advantage, including the No UPCODE Act, and urge Congress to keep the promise to America's seniors.' Any loss in health plan members covered by Medicare Advantage would be an added blow to health insurers. They need large numbers of subscribers paying premiums to cover their costs. Many of these same health insurers have been hit hard by rising costs from an influx of seniors purchasing Medicare Advantage.
