Ascletis' oral GLP-1RA shows weight loss potential in early trial
Ascletis has announced its oral glucagon-like peptide-1 receptor agonist (GLP-1RA) has achieved early weight loss in a Phase Ib trial and is now preparing to progress to a Phase IIa study.
The China-based biotech's once-daily tablet ASC30 demonstrated a placebo-adjusted mean body weight reduction from baseline of up to 6.5% after four weeks of treatment.
The company's stock, listed on the Hong Kong Stock Exchange (HKSE) has risen 4.55% today following the announcement. Despite this rise, the stock price has still not yet recovered from the hit it took after Donald Trump announced sweeping global tariffs on 2 April, with the company's stock continuing to fall as both China and the US continued to respond with reciprocal tariffs.
The update follows a turbulent week in the oral obesity drug space, highlighted by a surge in Eli Lilly's stock after the company reported successful data from the first of seven anticipated Phase III readouts in 2025 for its oral GLP-1RA orforglipron. Meanwhile, Pfizer dropped the development of its oral weight loss candidate danuglipron after a drug-induced liver injury.
Ascletis conducted the US Food and Drug Administration (FDA) approved Phase Ib multiple ascending dose (MAD) study (NCT06680440), in the US, with plans for the Phase IIa trial also submitted to the FDA. Patients enrolled were classified as obese and split into three cohorts each with a different weekly titration scheme.
In the first cohort, mid-starting dose with slow titration, (2mg, 5mg, 10mg, and 20mg), there was a 4.5% placebo-adjusted mean body weight reduction, with the benefit of no vomiting seen in this dose group. The maximum weight loss recorded in this group was 7.6%.
In the second group, mid-starting dose and normal titration (2mg, 10mg, 20mg, and 40mg), a 6.5% placebo-adjusted mean body weight reduction was recorded. The maximum weight loss reported in this arm was 9.1%.
In the third cohort, the high-starting dose and fast titration (5mg, 15mg, 30mg, 60mg), there was a placebo-adjusted mean body weight reduction from baseline of 5.0%, with a maximum body weight reduction from baseline of 9.3%.
Ascletis said that in the third arm, there were two outliers, each with a body weight reduction of 1.8% from baseline, which was not observed in the lower dose schemes. Excluding these two outliers, placebo-adjusted mean body weight reduction from baseline in the high-dose cohort was 6.1%.
In all treatment arms, no weight plateau was observed. Meanwhile, in the placebo arm, mean body weight increase from baseline was 0.2%.
Ascletis says that the drug was generally safe and well tolerated in both the lower dose arms, with 'comparable gastrointestinal tolerability to orforglipron'.
The majority of gastrointestinal-related adverse events (AEs) were mild and short-lived. In the lowest dose cohort, there were no incidents of vomiting. While gastrointestinal tolerability in the high-dose arm was lower, Ascletis said there were still no serious AEs observed in any cohort.
For the 13-week Phase IIa trial, Ascletis plans to use a "lower starting dose and slower titration" dosing schedule. The application for the study has been submitted to the FDA, with the company hoping to initiate the study at the beginning of the third quarter of 2025.
In March, Ascletis announced data from its subcutaneous weight loss therapy ASC47 which is designed to preserve muscle mass. The data supports a monthly or twice-monthly dosing regimen of the selective small molecule agonist.
"Ascletis' oral GLP-1RA shows weight loss potential in early trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
16 minutes ago
- Yahoo
Gilbane, F.A. Wilhelm top out $4.3B Indianapolis hospital
This story was originally published on Construction Dive. To receive daily news and insights, subscribe to our free daily Construction Dive newsletter. A joint venture of Providence, Rhode Island-based Gilbane Building Co. and Indianapolis-based F.A. Wilhelm topped out Indiana University Health's new downtown Indianapolis hospital, according to a May 27 Gilbane news release. The $4.3 billion, 2.1 million-square-foot hospital, announced in August 2020, will contain 864 inpatient rooms, 50 operating rooms and two helipads, according to Gilbane's project page. It will combine the health system's Methodist and University Hospitals, and is on track to finish in 2027, according to a June 2024 construction update. The medical project, initially budgeted at $1.6 billion, swelled to $4.3 billion in 2023. Growing construction costs of more than 20% of the initial budget and a height increase in the hospital's three bed towers to 16 stories initially increased it to $2.31 billion, according to a 2023 news release from the hospital network. Along with those construction costs, support buildings and other infrastructure — which include medical offices, parking garages and logistics space — tacked on an additional $1.98 billion to the project's price tag, per the news release. Combined, the inflated costs and additional work more than doubled the original budget. The hospital will also feature three clinical institutes for cancer, cardiovascular and neuroscience care, according to the hospital's project page. The complex will include bridges to the Capitol View medical office building, the Indiana University School of Medicine and the South Support Building, per Gilbane. At a lower level, below-grade tunnels will traverse from the hospital to the School of Medicine, South Support Building and central utility plant. 'Reaching the topping-out milestone is a proud moment for our entire team,' said Aaron Perry, Gilbane's project director, in the release. 'It reflects years of hard work, coordination, and a shared dedication to safety and quality.' Sign in to access your portfolio
Yahoo
24 minutes ago
- Yahoo
L'Oréal acquires a majority stake in British skincare brand Medik8
L'Oréal has acquired a majority stake in the UK's Medik8 as it seeks to expand its position in the skincare market, the French beauty giant confirmed on Monday. As part of the deal, private equity firm Inflexion will remain a minority shareholder, and the current management committee will also stay in their roles. The cost of the stake is officially undisclosed, although the Financial Times reported last week that the potential deal was worth around €1bn. L'Oréal's share price was roughly unchanged on the news. 'We are delighted to welcome Medik8 to the L'Oréal family,' said Cyril Chapuy, President of L'Oréal LUXE. 'As a premium skincare range, with high levels of proven efficacy at an accessible price point, Medik8 perfectly complements our existing skincare portfolio,' he added. L'Oréal has been seeking to capitalise on the boom in science-driven skincare, partly driven by social media influencers. Brands already under its 'Dermatological Beauty Division' include La Roche-Posay, Cerave, Vichy, Skinceuticals, and Skinbetter Science. Related L'Oréal acquires Galderma stake and targets the injectables market The Body Shop goes into administration, with hundreds of UK jobs at risk This unit brought in over €7bn in revenue in 2024, representing an almost 10% year-on-year rise, making it L'Oréal's fastest-growing division. Seeking to expand its portfolio, L'Oréal bought soap maker Aesop in 2023, and Korean beauty brand Dr.G in December. Last year, L'Oréal also acquired a 10% stake in skincare firm Galderma, as well as acquiring the beauty licence for Miu Miu. At the time of the Galderma deal, the French firm said it was 'increasingly investing in a more holistic approach, spanning the entire beauty routine' — thereby 'anticipating and intercepting the signs of skin ageing'. Medik8, founded in 2009, specialises in anti-ageing treatments and was bought by UK-based private equity firm Inflexion in 2021. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
38 minutes ago
- Yahoo
An Uproar at the NIH
The Atlantic Daily, a newsletter that guides you through the biggest stories of the day, helps you discover new ideas, and recommends the best in culture. Sign up for it here. Updated at 10:26 a.m. on June 9, 2025 Since winning President Donald Trump's nomination to serve as the director of the National Institutes of Health, Jay Bhattacharya—a health economist and prominent COVID contrarian who advocated for reopening society in the early months of the pandemic—has pledged himself to a culture of dissent. 'Dissent is the very essence of science,' Bhattacharya said at his confirmation hearing in March. 'I'll foster a culture where NIH leadership will actively encourage different perspectives and create an environment where scientists, including early-career scientists and scientists that disagree with me, can express disagreement, respectfully.' Two months into his tenure at the agency, hundreds of NIH officials are taking Bhattacharya at his word. More than 300 officials, from across all of the NIH's 27 institutes and centers, have signed and sent a letter to Bhattacharya that condemns the changes that have thrown the agency into chaos in recent months—and calls on their director to reverse some of the most damaging shifts. Since January, the agency has been forced by Trump officials to fire thousands of its workers and rescind or withhold funding from thousands of research projects. Tomorrow, Bhattacharya is set to appear before a Senate appropriations subcommittee to discuss a proposed $18 billion slash to the NIH budget—about 40 percent of the agency's current allocation. The letter, titled the Bethesda Declaration (a reference to the NIH's location in Bethesda, Maryland), is modeled after the Great Barrington Declaration, an open letter published by Bhattacharya and two of his colleagues in October 2020 that criticized 'the prevailing COVID-19 policies' and argued that it was safe—even beneficial—for most people to resume life as normal. The approach that the Great Barrington Declaration laid out was, at the time, widely denounced by public-health experts, including the World Health Organization and then–NIH director Francis Collins, as dangerous and scientifically unsound. The allusion in the NIH letter, officials told me, isn't meant glibly: 'We hoped he might see himself in us as we were putting those concerns forward,' Jenna Norton, a program director at the National Institute of Diabetes and Digestive and Kidney Diseases, and one of the letter's organizers, told me. None of the NIH officials I spoke with for this story could recall another time in their agency's history when staff have spoken out so publicly against a director. But none of them could recall, either, ever seeing the NIH so aggressively jolted away from its core mission. 'It was time enough for us to speak out,' Sarah Kobrin, a branch chief at the National Cancer Institute, who has signed her name to the letter, told me. To preserve American research, government scientists—typically focused on scrutinizing and funding the projects most likely to advance the public's health—are now instead trying to persuade their agency's director to help them win a political fight with the White House. In an emailed statement, Bhattacharya said, 'The Bethesda Declaration has some fundamental misconceptions about the policy directions the NIH has taken in recent months, including the continuing support of the NIH for international collaboration. Nevertheless, respectful dissent in science is productive. We all want the NIH to succeed.' A spokesperson for HHS also defended the policies the letter critiqued, arguing that the NIH is 'working to remove ideological influence from the scientific process' and 'enhancing the transparency, rigor, and reproducibility of NIH-funded research.' The agency spends most of its nearly $48 billion budget powering science: It is the world's single-largest public funder of biomedical research. But since January, the NIH has canceled thousands of grants—originally awarded on the basis of merit—for political reasons: supporting DEI programming, having ties to universities that the administration has accused of anti-Semitism, sending resources to research initiatives in other countries, advancing scientific fields that Trump officials have deemed wasteful. Prior to 2025, grant cancellations were virtually unheard-of. But one official at the agency, who asked to remain anonymous out of fear of professional repercussions, told me that staff there now spend nearly as much time terminating grants as awarding them. And the few prominent projects that the agency has since been directed to fund appear either to be geared toward confirming the administration's biases on specific health conditions, or to benefit NIH leaders. 'We're just becoming a weapon of the state,' another official, who signed their name anonymously to the letter, told me. 'They're using grants as a lever to punish institutions and academia, and to censor and stifle science.' NIH officials have tried to voice their concerns in other ways. At internal meetings, leaders of the agency's institutes and centers have questioned major grant-making policy shifts. Some prominent officials have resigned. Current and former NIH staffers have been holding weekly vigils in Bethesda, commemorating, in the words of the organizers, 'the lives and knowledge lost through NIH cuts.' (Attendees are encouraged to wear black.) But these efforts have done little to slow the torrent of changes at the agency. Ian Morgan, a postdoctoral fellow at the NIH and one of the letter's signers, told me that the NIH fellows union, which he is part of, has sent Bhattacharya repeated requests to engage in discussion since his first week at the NIH. 'All of those have been ignored,' Morgan said. By formalizing their objections and signing their names to them, officials told me, they hope that Bhattacharya will finally feel compelled to respond. (To add to the public pressure, Jeremy Berg, who led the NIH's National Institute of General Medical Sciences until 2011, is also organizing a public letter of support for the Bethesda Declaration, in partnership with Stand Up for Science, which has organized rallies in support of research.) Scientists elsewhere at HHS, which oversees the NIH, have become unusually public in defying political leadership, too. Last month, after Health Secretary Robert F. Kennedy Jr.—in a bizarre departure from precedent—announced on social media that he was sidestepping his own agency, the CDC, and purging COVID shots from the childhood-immunization schedule, CDC officials chose to retain the vaccines in their recommendations, under the condition of shared decision making with a health-care provider. Many signers of the Bethesda letter are hopeful that Bhattacharya, 'as a scientist, has some of the same values as us,' Benjamin Feldman, a staff scientist at the National Institute of Child Health and Human Development, told me. Perhaps, with his academic credentials and commitment to evidence, he'll be willing to aid in the pushback against the administration's overall attacks on science, and defend the agency's ability to power research. But other officials I spoke with weren't so optimistic. Many at the NIH now feel they work in a 'culture of fear,' Norton said. Since January, NIH officials have told me that they have been screamed at and bullied by HHS personnel pushing for policy changes; some of the NIH leaders who have been most outspoken against leadership have also been forcibly reassigned to irrelevant positions. At one point, Norton said, after she fought for a program focused on researcher diversity, some members of NIH leadership came to her office and cautioned her that they didn't want to see her on the next list of mass firings. (In conversations with me, all of the named officials I spoke with emphasized that they were speaking in their personal capacity, and not for the NIH.) Bhattacharya, who took over only two months ago, hasn't been the Trump appointee driving most of the decisions affecting the NIH—and therefore might not have the power to reverse or overrule them. HHS officials have pressured agency leadership to defy court orders, as I've reported; mass cullings of grants have been overseen by DOGE. And as much as Bhattacharya might welcome dissent, he so far seems unmoved by it. In early May, Berg emailed Bhattacharya to express alarm over the NIH's severe slowdown in grant making, and to remind him of his responsibilities as director to responsibly shepherd the funds Congress had appropriated to the agency. The next morning, according to the exchange shared with me by Berg, Bhattacharya replied saying that, 'contrary to the assertion you make in the letter,' his job was to ensure that the NIH's money would be spent on projects that advance American health, rather than 'on ideological boondoggles and on dangerous research.' And at a recent NIH town hall, Bhattacharya dismissed one staffer's concerns that the Trump administration was purging the identifying variable of gender from scientific research. (Years of evidence back its use.) He echoed, instead, the Trump talking point that 'sex is a very cleanly defined variable,' and argued that gender shouldn't be included as 'a routine question in order to make an ideological point.' The officials I spoke with had few clear plans for what to do if their letter goes unheeded by leadership. Inside the agency, most see few levers left to pull. At the town hall, Bhattacharya also endorsed the highly contentious notion that human research started the pandemic—and noted that NIH-funded science, specifically, might have been to blame. When dozens of staffers stood and left the auditorium in protest, prompting applause that interrupted Bhattacharya, he simply smiled. 'It's nice to have free speech,' he said, before carrying right on. Article originally published at The Atlantic
