Ascletis Starts Phase III Trials of Oral GLP-1 Drug ASC30 for Chronic Weight Management

First Participant Dosed in Global Phase III Program

Ascletis Pharma Inc. has started a global Phase III clinical program for ASC30, an investigational once-daily oral small molecule GLP-1 receptor agonist being developed for chronic weight management and diabetes.

The company announced that the first participant has been dosed in the program, marking the move of ASC30 into the pivotal stage of clinical development.

The Phase III program will evaluate whether ASC30 can safely and effectively help adults with obesity or overweight manage their body weight over a longer treatment period.

The program is expected to include approximately 4,600 participants across clinical sites in the United States, Europe and Canada.

Two Phase III Trials Will Evaluate ASC30

The global Phase III program consists of two pivotal studies called AURORA-1 and AURORA-2.

Both studies are multicenter, randomized, double-blind and placebo-controlled trials. They are designed to compare once-daily oral ASC30 with placebo over 72 weeks.

AURORA-1 Study

AURORA-1 is evaluating ASC30 in adults living with obesity or overweight who do not have type 2 diabetes.

Participants with obesity will have a body mass index (BMI) of at least 30 kg/m². People with overweight will have a BMI of at least 27 kg/m² along with at least one weight-related health condition.

Participants will receive one of three ASC30 maintenance doses: 20 mg, 40 mg or 60 mg, or placebo.

The main goal of the study is to measure the percentage change in body weight from baseline to Week 72.

AURORA-2 Study

AURORA-2 will evaluate ASC30 in adults with obesity or overweight who also have type 2 diabetes.

Participants will receive 20 mg, 40 mg or 60 mg of ASC30 once daily, or placebo.

Like AURORA-1, the primary endpoint is the percentage change in body weight from baseline to Week 72.

Together, the two studies are designed to give Ascletis a broad view of how ASC30 performs in people with obesity or overweight, both with and without type 2 diabetes.

What Ascletis Is Trying to Achieve With ASC30

ASC30 is being developed as an oral small molecule GLP-1 receptor agonist.

GLP-1-based medicines have become an important part of obesity treatment because they can help regulate appetite, food intake and body weight. Many of the currently available treatments in this area are injectable medicines.

Ascletis is developing ASC30 as a once-daily oral option.

The company believes an effective oral treatment could give patients another choice and may make long-term treatment easier for some people.

Ascletis said ASC30 enters Phase III development with results from its Phase II program showing a competitive weight-loss profile, favorable gastrointestinal tolerability and no observed hepatic safety signals.

The Phase III studies will provide more data on whether these earlier findings can be confirmed in a much larger patient population.

Results Expected in 2028

Ascletis expects to report topline results from the AURORA Phase III program in the third quarter of 2028.

If the results support the development of ASC30, the company expects to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration by the end of 2028.

A Marketing Authorisation Application (MAA) submission to the European Medicines Agency is expected in early 2029.

This timeline means that several important clinical and regulatory milestones are expected over the next few years.

ASC30 Could Add to the Oral GLP-1 Market

Ascletis believes ASC30 could potentially become the second oral small molecule GLP-1 receptor agonist available in the United States and Europe if it receives regulatory approval.

The company is also building a larger oral small molecule obesity portfolio around the ASC30 program.

Its pipeline includes combination candidates designed to target more than one pathway involved in weight management.

These include ASC30_48FDC, a fixed-dose combination targeting GLP-1 and GIP pathways, and ASC30_48_39FDC, which combines GLP-1, GIP and amylin receptor activity.

Ascletis is also developing ASC30_39FDC, which combines its oral GLP-1 candidate with an oral amylin receptor agonist.

The goal is to create convenient treatment options that can potentially be taken as one pill once a day.

Why Oral Obesity Treatments Are Getting Attention

Obesity is a chronic disease associated with many other health conditions. Ascletis noted that obesity has been linked to more than 200 comorbidities.

Injectable incretin therapies have changed the way obesity is treated, but an oral option could address some of the practical challenges associated with injectable medicines.

For patients who prefer tablets, a once-daily oral treatment could offer a different approach to long-term weight management.

The challenge for Ascletis will be showing that ASC30 can deliver meaningful weight loss while maintaining a safety and tolerability profile that supports continued use.

The AURORA trials are designed to provide the data needed to answer those questions.

ASC30 Was Discovered and Developed by Ascletis

ASC30 was discovered and developed internally by Ascletis.

The company describes it as a fully biased oral small molecule GLP-1 receptor agonist and the main program within its oral small molecule obesity portfolio.

Ascletis is using its proprietary technology platforms, including Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD), Ultra-Long-Acting Platform (ULAP) and Peptide Oral Transport ENhancement Technology (POTENT), as part of its broader drug development strategy.

The company is developing both small molecule and peptide medicines for obesity and other metabolic diseases.

Ascletis Is Building a Broader Obesity Pipeline

ASC30 is not the only obesity program being developed by Ascletis.

The company's pipeline includes oral and injectable candidates targeting GLP-1, GIP, amylin and other metabolic pathways.

Its programs include ASC39, an oral amylin receptor agonist, as well as ASC36, an amylin peptide being developed for longer-acting administration.

Ascletis is also working on peptide-based candidates such as ASC35 and ASC37, along with several fixed-dose combinations.

These programs are intended to give the company multiple approaches to treating obesity and related metabolic diseases.

Ascletis Plans to Fully Fund the Phase III Program

Ascletis said it maintains a strong balance sheet with sufficient cash on hand to support operations into 2029.

According to the company, this financial position is expected to allow it to fully fund the ASC30 Phase III program beyond the planned U.S. and European regulatory submissions.

This is important because large Phase III trials can require significant investment, particularly when thousands of participants are involved across multiple countries.

The AURORA program is expected to be conducted across the United States, Europe and Canada, with approximately 4,600 participants between the two pivotal studies.

About Ascletis Pharma

Ascletis Pharma Inc. is a fully integrated biotechnology company focused on developing and commercializing therapies for metabolic diseases.

The company uses its proprietary drug discovery and drug delivery technologies to develop small molecules and peptides.

ASC30 is currently its lead program for chronic weight management and diabetes and has now entered global Phase III development.

Ascletis is listed on the Hong Kong Stock Exchange under the ticker 1672.HK.