Breakthrough Clinical Results
Ascletis Pharma Inc. announced that it will present data from a 28-day multiple ascending dose study of its oral small molecule GLP-1 receptor (GLP-1R) agonist, ASC30, at the 61st European Association for the Study of Diabetes (EASD) Annual Meeting. The study (NCT06680440) demonstrated superior weight loss in participants with obesity. Ascletis expects to report topline data from a Phase IIa clinical study of ASC30 in participants with obesity or overweight in the fourth quarter of 2025. ASC30 is a new chemical entity with patent protection until 2044. The presentation will highlight the efficacy and safety data of ASC30, positioning it as a potentially differentiated treatment option for obesity.
Key Highlights
- Data from a 28-day multiple ascending dose study of ASC30 will be presented at the EASD Annual Meeting.
- ASC30 demonstrated superior weight loss in participants with obesity.
- Topline data from a Phase IIa study in obesity/overweight participants is expected in Q4 2025.
- ASC30 has unique properties enabling both oral and subcutaneous administration.
ASC30 Clinical Trials Beyond Obesity
Based on a thorough review of available information, there is insufficient data regarding clinical trials of ASC30 for indications other than obesity management.
The current pharmaceutical development pipeline for this antisense oligonucleotide appears to be primarily focused on obesity-related applications, with no documented evidence of trials for other therapeutic indications.
Without specific information about non-obesity clinical trials for ASC30, details regarding intervention models, trial design methodologies, and intervention protocols cannot be provided.
The mechanism of action of ASC30 in metabolic disorders beyond obesity also remains undocumented in the available information.
As pharmaceutical development is an evolving field, future research may expand the application of ASC30 to address other medical conditions, but at present, the clinical trial landscape appears limited to obesity management applications.
For patients and healthcare providers interested in ASC30 applications, focusing on its current development in the obesity treatment space would provide the most relevant and evidence-based information.
Incidence and Prevalence
Global Obesity Prevalence: Latest Estimates
The global epidemic of obesity has reached pandemic dimensions, with prevalence rates increasing dramatically worldwide. According to recent data, the age-standardized prevalence of obesity has shown a significant upward trend, increasing from 4.6% in 1980 to 14.0% in 2019. This represents a nearly threefold increase in obesity prevalence since 1975.
The World Health Organization released a report in May 2022 stating that 60% of citizens in Europe are either overweight or obese. Globally, the American and European regions have the highest obesity prevalence, with the United States and Russia being the countries with the most obese residents.
Demographic patterns reveal that obesity prevalence is higher in women than in men across all age groups. The prevalence typically increases with age, reaching its highest point between ages 50 to 65 years, followed by a slight downward trend afterward.
A 2023 US study using relative fat mass (RFM) instead of BMI revealed a much higher prevalence of general obesity than previously estimated. Among US women, RFM-defined obesity prevalence was 64.7% in 2017-2020, representing a linear increase of 13.9 percentage points compared to 1999-2000. For US men, RFM-defined obesity prevalence was 45.8%, a linear increase of 12.0 percentage points. In contrast, BMI-defined obesity prevalence was only 42.2% for women and 42.0% for men, suggesting potential underestimation using traditional metrics.
In China, a 2022 study estimated that 85 million adults aged 18-69 years were obese in 2018, three times as many as in 2004. The standardized mean BMI in China rose from 22.7 kg/m² in 2004 to 24.4 kg/m² in 2018, with obesity prevalence increasing from 3.1% to 8.1% during this period.
Regional variations are significant, with the Middle East, Central and Eastern Europe, and North America having higher prevalence rates. A 2011 study from Saudi Arabia found the prevalence of metabolic syndrome was 31.4%, with 75% of participants suffering from overweight and obesity. Among school children in Turkey (2015), the prevalence of obesity was 18.0%, with overweightness including obesity present in 26.3% of children.
The increasing prevalence has been attributed to modernization, economic development, urbanization, a progressively more sedentary lifestyle, and consumption of less healthy diets. Specifically, high-fat diets stimulate voluntary energy intake, while decreased physical activity reduces energy expenditure. Interestingly, obesity is now associated with poverty even in developing countries, where prevalence rates are increasing quickly.
Current global prevalence estimates exceed 250 million people (reported in 2014), making obesity one of the most significant public health challenges of our time.
MoA used in other indications
No Information Available on ASC30 Clinical Trials
After thorough review, there is no available information regarding ASC30 clinical trials for indications other than obesity. The data does not contain any details about:
- The mechanism of action (MoA) of ASC30
- Clinical trials investigating ASC30 for any indications
- Intervention models used in ASC30 trials
- Any therapeutic applications of ASC30 beyond obesity
- Dosing regimens or administration protocols
Without specific information on ASC30's clinical development program, it is not possible to provide details about additional indications being explored or the intervention models employed in such trials.