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
30 minutes ago
- Yahoo
‘Boil in the bag' funerals could be introduced in UK after European roll-out in Ireland
"Boil in a bag" funerals - already used widely in America - could soon be made available across the UK. This environmentally friendly, yet controversial, way to say your final goodbyes to a loved one has already been rolled out in Ireland back in 2023 and could come to the UK next. This unusual method, officially known as water cremation or alkaline hydrolysis, is currently effectively banned in the UK, but could well get the legal go-ahead following the independent Law Commission's new consultation into funerary methods. READ MORE: Dad, 32, who flew to Turkey for family holiday dies hours after being escorted off plane READ MORE: Met Office verdict on UK heatwave this WEEK as temperatures to climb to 29C Already available across 30 US states, as well as Canada and South Africa, the first European water cremation facility, or resomation, opened its doors in early 2023 in Navan, Co Meath, Ireland. Traditional burials can lead to embalming fluid seeping into the grave soil, while each gas-powered fire cremation releases around 245kg of CO2 into the atmosphere, according to UK-based cemetery and crematorium development the CDS Group. By comparison, figures from Resomation Ltd, the founding body for alkaline hydrolysis, show just 28kg of CO2 is released into the atmosphere per water cremation. Unlike conventional cremations, these eco-friendly farewells, which take between three to four hours, also don't release harmful mercury emissions into the atmosphere. But you might be wondering how the process actually works. Well, first the body is loaded into the alkaline hydrolysis machine, which calculates the amount of water and potassium hydroxide required. The machine locks and an alkaline solution fills the pressurised tank, which is gently heated to 152C. The remains get broken into their chemical components - amino acids, peptides, sugars and salt - leaving behind a liquid that is then cooled in another tank until sterile and free from any remaining tissue or DNA. Around 330 gallons of brown-coloured liquid will be washed down the drain, while the softened bones are ground to powder in a reducer, and presented in an urn to the grieving family. In 2017, Wired journalist Hayley Campbell described the process in colourful detail after seeing a resomator in action at the University of California, Los Angeles (UCLA). Hayley wrote: "Over the course of up to four hours, the strong alkaline base causes everything but the skeleton to break down to the original components that built it: sugar, salt, peptides and amino acids; DNA unzips into its nucleobases, cytosine, guanine, adenine, thymine. "The body becomes fertiliser and soap, a sterile watery liquid that looks like weak tea. The liquid shoots through a pipe into a holding tank in the opposite corner of the room, where it will cool down, be brought down to an acceptable pH for the water treatment plant, and be released down the drain." Noting that "it's not actually that terrible", Hayley revealed: "The human body, liquefied, smells like steamed clams." Highlighting why this process is still a bit of a taboo in an interview with The Telegraph, Dr Lian Lundy, a wastewater specialist from Middlesex University, explained: "Some people view it as basically mixing up my loved one with poo in the sewer and they don't like that. "But there's a lot that goes into the sewer that we don't really think about – waste from mortuaries and hospitals and all sorts of things that we don't know about – so from that perspective, it's not really any different."
New York Times
41 minutes ago
- New York Times
F.D.A. Looks to A.I. to Enhance Efficiency
The Food and Drug Administration is planning to use artificial intelligence to 'radically increase efficiency' in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA. Another initiative involves a review of chemicals and other 'concerning ingredients' that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count. 'The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,' Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article. The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration's efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly. Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device. 'I don't want to be dismissive of speeding reviews at the F.D.A.,' said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. 'I think that there is great potential here, but I'm not seeing the beef yet.' Want all of The Times? Subscribe.
Bloomberg
an hour ago
- Bloomberg
FDA Pauses Trials of Gilead HIV Combination After Safety Signal
Gilead Sciences Inc. said federal regulators had placed on hold trials of a new experimental once-weekly HIV drug combination therapy after white blood cell counts dropped in some of the patients. The studies were testing two experimental HIV drugs, GS-1720 and GS-4182, when given together. Gilead said the Food and Drug Administration paused the trials due to a ' safety signal ' triggered by a decrease in lymphocyte levels in some patients given the therapy. Lymphocytes are a type of white blood cell that play a critical role in the immune system's ability to fight infections.
