logo
Ascletis' oral GLP-1RA shows weight loss potential in early trial

Ascletis' oral GLP-1RA shows weight loss potential in early trial

Yahoo23-04-2025

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.

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Mushroom Recall Sparks Nationwide Warning to Customers
Mushroom Recall Sparks Nationwide Warning to Customers

Newsweek

time28 minutes ago

  • Newsweek

Mushroom Recall Sparks Nationwide Warning to Customers

Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. Hofood99 Inc. is recalling packages of their Enoki Mushrooms due to fears the product may be contaminated with listeria. Newsweek reached out to the company via phone for additional comment on Wednesday and left a voicemail. Why It Matters Numerous recalls have been initiated this year due to the potential for the following: damaged products, foodborne illness, contamination and undeclared food allergens. Millions of Americans experience food sensitivities or food allergies every year. According to the Food and Drug Administration (FDA), the nine "major" food allergens in the U.S. are eggs, milk, fish, wheat, soybeans, Crustacean shellfish, sesame, tree nuts and peanuts. The FDA warns that Listeria monocytogenes is an organism that could cause serious and sometimes fatal infections in frail or older people, young children and those with weakened immune systems. Listeria could also lead to stillbirths or miscarriages in pregnant women, the FDA says. What To Know According to the FDA alert, the mushrooms were distributed nationwide to stores and retailers. The recalled mushrooms are sold in 200-gram green plastic packaging with a with UPC Barcode of 6 976532 310051 seen on the back label. No illnesses or injuries have been reported related to the recalled mushrooms. The mushrooms were distributed by Hofood99 Inc., located at 21903 56th Avenue Oakland Gardens, New York 11364. Recalled packages of Enoki Mushroom from Hofood99 Inc. can be seen in a June 11, 2025, recall alert. (Photo from the U.S. Food and Drug Administration) Recalled packages of Enoki Mushroom from Hofood99 Inc. can be seen in a June 11, 2025, recall alert. (Photo from the U.S. Food and Drug Administration) What People Are Saying The FDA in the alert in part: "The contamination was discovered after samples were collected from a store in Michigan and subsequent analysis by Michigan Department of Agriculture & Rural Development (MDARD) Laboratory Division revealed the presence of Listeria monocytogenes." In an email to Newsweek in January, the FDA said: "Most recalls in the U.S. are carried out voluntarily by the product manufacturer and when a company issues a public warning, typically via news release, to inform the public of a voluntary product recall, the FDA shares that release on our website as a public service. "The FDA's role during a voluntary, firm-initiated, recall is to review the recall strategy, evaluate the health hazard presented by the product, monitor the recall, and as appropriate alert the public and other companies in the supply chain about the recall," the FDA continued. It added: "The FDA provides public access to information on recalls by posting a listing of recalls according to their classification in the FDA Enforcement Report, including the specific action taken by the recalling company. The FDA Enforcement Report is designed to provide a public listing of products in the marketplace that are being recalled." Additional information on recalls can be found via the FDA's Recalls, Market Withdrawals, & Safety Alerts. What Happens Next Customers who have purchased the recalled mushrooms may return the product to the original place of purchase for a full refund or destroy it, the FDA says. People with additional questions may contact the company at (917) 756-9833 weekdays from 9 a.m. to 2 p.m.

8 ice cream flavors recalled in Ohio
8 ice cream flavors recalled in Ohio

Yahoo

timean hour ago

  • Yahoo

8 ice cream flavors recalled in Ohio

WAUSEON, Ohio — An Ohio-based creamery has announced a voluntary recall due to undeclared allergens in eight of their ice cream flavors. According to the Ohio Department of Agriculture, Turkeyfoot Creek Creamery of Wauseon, Ohio, is recalling the following flavors of ice cream; Avalanche, Chocolate Peanut Butter, Chocolate Strawberry, Chocolate Brownie Bites, Cookies and Cream, Cookie Dough, Cacao and Mocha. Massive egg recall hits Ohio Walmart stores The affected products are all packaged in pint containers and were distributed to six stores, located in Canton, Cleveland, West Unity, and Arlington, Ohio. As well, as two stores located out of state, with one in Fort Wayne, Indiana, and the other in Hudson, Michigan, read a press release from the Ohio Department of Agriculture. Young mother killed in shooting at Cleveland Metroparks Mill Creek Falls 'There have been no reports of illness involving products addressed in this recall, however, individuals exhibiting signs or symptoms of an allergic reaction after consuming Turkeyfoot Creek Creamery Ice Cream involved in this recall should contact a physician immediately,' stated the release. All affected products have been removed from store shelves. Consumers can return recalled products to the place of purchase for a refund. Consumers with questions can call 419-583-7124. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

Topeka's KMC Dermatology Is First in Kansas to Offer Nonsurgical GentleCure™ Treatment Option for Common Skin Cancer
Topeka's KMC Dermatology Is First in Kansas to Offer Nonsurgical GentleCure™ Treatment Option for Common Skin Cancer

Yahoo

timean hour ago

  • Yahoo

Topeka's KMC Dermatology Is First in Kansas to Offer Nonsurgical GentleCure™ Treatment Option for Common Skin Cancer

BURR RIDGE, Ill., June 11, 2025 /PRNewswire/ -- SkinCure Oncology, the industry leader in providing a comprehensive cancer center model for the delivery of Image-Guided Superficial Radiation Therapy (Image-Guided SRT or IGSRT) for the treatment of nonmelanoma skin cancer (NMSC), presented to dermatology patients and professionals as the GentleCure Experience™, today announced its first availability in Kansas at an event at Topeka's KMC Dermatology. Image-Guided SRT is the only treatment for nonmelanoma skin cancer (basal and squamous cell carcinoma) that uses ultrasound imaging to help clinicians direct low-level x-rays to targeted areas of the skin, killing cancer cells. For patients treated with Image-Guided SRT, the cure rate (freedom from recurrence at six years) has been shown to be greater than 99 percent, with researchers reporting that for appropriately selected early-stage nonmelanoma skin cancers, Image-Guided SRT is a clinically equivalent alternative to Mohs surgery and statistically significant in superiority to non-Image-Guided SRT. Dr. Joseph Gadzia of KMC Derm noted, "More than 26,000 individuals in Kansas are expected to be diagnosed with nonmelanoma skin cancer this year. We know that sun exposure is the main cause of this type of cancer but there are other factors as well. For those who have been diagnosed with nonmelanoma skin cancer, we now offer a nonsurgical treatment option which we call the GentleCure Experience, and we are proud to be the first practice in the state to offer it." Dr. Gadzia also added, "While most common skin cancers have been treated with Mohs surgery, this newer treatment option achieves close to the same success rate with no surgery, no surgical scarring, and no bleeding. As of this past April, more than 100,000 patients have been successfully treated with Image-Guided SRT in the United States." Other speakers included Dr. Shekhar Challa; U.S. Senator Roger Marshall via video; Topeka Mayor Michael Padilla; Aaron Mays, Chairman of the Shawnee County Board of Commissioners; and John Mugler, District Director, Office of Senator Marshall. In addition, Kansas Governor Laura Kelly issued a gubernatorial proclamation declaring June 8 – 14 "Kansas Nonmelanoma Skin Cancer Awareness Week," noting that KMC Dermatology is the first practice in the state of Kansas to offer Image-Guided SRT. Kerwin Brandt, chief executive officer of Chicago-based SkinCure Oncology, said, "We are delighted to partner with KMC Dermatology to offer this highly effective, noninvasive treatment option for their patients. It is critical that patients everywhere have the choice of treating their nonmelanoma skin cancer without surgery." About SkinCure OncologySkinCure Oncology is the industry leader in providing a comprehensive model for the delivery of Image-Guided Superficial Radiation Therapy (Image-Guided SRT or IGSRT), the most advanced nonsurgical treatment for common skin cancer. The company partners with quality-focused dermatologists, Mohs surgeons and other physicians to bring cancer center-level radiation therapy treatment to private practices. Presented to patients as the GentleCure Experience™, Image-Guided SRT is available from some 500 physicians nationwide, with more than 100,000 patients having been treated. Learn more about the company at and visit for helpful consumer and patient information. Media Contact:Matt RussellRussell Public Communications520-232-9840mrussell@ View original content to download multimedia: SOURCE SkinCure Oncology 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

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store