Breakthrough Clinical Results
Ascletis Pharma announced the first participants have been dosed in a Phase IIa clinical trial (NCT07002905) evaluating ASC30, a novel small molecule oral GLP-1 receptor agonist, for the treatment of obesity. The 13-week, multi-center study will assess the efficacy, safety, and tolerability of ASC30 in obese and overweight individuals with at least one weight-related comorbidity. Previous Phase Ib data showed a placebo-adjusted mean body weight reduction of up to 6.5% after four weeks. Topline data from this Phase IIa study are expected in Q4 2025. ASC30 is designed for both oral and subcutaneous administration.
Key Highlights
- First participants dosed in a U.S. Phase IIa study of ASC30 for obesity.
- ASC30 demonstrated up to 6.5% placebo-adjusted mean body weight reduction in a Phase Ib study.
- Topline data from the Phase IIa study are expected in Q4 2025.
- ASC30 is a novel small molecule GLP-1R agonist with potential for both oral and subcutaneous administration.
Incidence and Prevalence
Global Obesity Epidemiology: Current Prevalence and Trends
Global Prevalence Trends
The worldwide prevalence of obesity has reached alarming levels, affecting at least 300 million people globally. This global epidemic has shown a dramatic increase over recent decades, with the worldwide prevalence of overweight and obesity doubling since 1980 to an extent that nearly a third of the world's population is now classified as overweight or obese.
The global age-standardized prevalence of obesity has nearly doubled from 6.4% (95% uncertainty interval 5.7-7.2%) in 1980 to 12.0% (11.5-12.5%) in 2008. Half of this rise occurred in the 20 years between 1980 and 2000, and half occurred in the 8 years between 2000 and 2008. More recent data shows that the worldwide prevalence of obesity more than doubled between 1990 and 2022 (men, 4.8%-14.0%; women, 8.8%-18.5%).
Between 1980 and 2013, the proportion of adults with a body-mass index (BMI) of 25 kg/m² or greater increased from 28.8% to 36.9% in men, and from 29.8% to 38.0% in women. The age-standardized prevalence of overweight increased from 24.6% (22.7-26.7%) to 34.4% (33.2-35.5%) during the 28-year period from 1980 to 2008.
Regional and Demographic Variations
The prevalence of obesity varies significantly across countries and demographic groups. In 2008, female obesity prevalence ranged from 1.4% (0.7-2.2%) in Bangladesh and 1.5% (0.9-2.4%) in Madagascar to 70.4% (61.9-78.9%) in Tonga and 74.8% (66.7-82.1%) in Nauru. Male obesity was below 1% in Bangladesh, Democratic Republic of the Congo, and Ethiopia, and was highest in Cook Islands (60.1%, 52.6-67.6%) and Nauru (67.9%, 60.5-75.0%).
In some countries, the estimated prevalence of obesity exceeded 50% in men in Tonga and in women in Kuwait, Kiribati, Federated States of Micronesia, Libya, Qatar, Tonga, and Samoa. In the United States, more than one third of the adult population is affected by obesity, with the prevalence having increased by 40% between 1980 and 1990.
Socioeconomic and Demographic Factors
The frequency of obesity is influenced by age, sex, race and has increased during the last 30 years. Studies across multiple countries (England, France, Finland, Italy, Norway, and USA) show that obesity prevalence among lower educated groups has exceeded that of higher educated groups throughout the study period, except among American men.
A comparable increase across educational levels was observed until approximately 2000. Recently, obesity prevalence stagnated among higher educated groups in Finland, France, Italy, and Norway and lower educated groups in England and the USA. The stagnation among higher socio-economic groups but not lower socio-economic groups suggests that the latter will likely experience the greatest future burden of obesity.
Childhood and Adolescent Obesity
Prevalence has increased substantially in children and adolescents in developed countries; 23.8% of boys and 22.6% of girls were overweight or obese in 2013. The prevalence of overweight and obesity has also increased in children and adolescents in developing countries, from 8.1% to 12.9% in 2013 for boys and from 8.4% to 13.4% in girls. Recently, an increase in superobesity in childhood has been observed, especially in the United States.
Global Health Challenge
Because of the established health risks and substantial increases in prevalence, obesity has become a major global health challenge. Not only is obesity increasing, but no national success stories have been reported in the past 33 years. The World Health Organization Consultation on obesity concluded that the global epidemic is an unintended consequence of modernization, economic development, urbanization and other societal changes.
Economic Burden
Economic Burden of Obesity in the USA and Europe
United States Economic Impact
In the USA, obesity cost approximately $2.7 billion in 2016, or $377 per inhabitant aged ≥25 years, with non-health care costs being dominant (80% of total societal costs). The main drivers of obesity costs were premature mortality (28%) and permanent sick leave (37%). If obesity rates remain at 2016 levels, costs will increase 9% by 2030, but with continued linear growth, costs could increase by 66%.
According to 2016 data, total medical costs attributable to obesity in the US rose to $126 billion per year, although the marginal cost of obesity declined for all obesity classes. The overall spending increase was due to an increase in obesity prevalence and a population shift to higher obesity classes. Obesity-related spending between 2006 and 2016 was relatively constant due to decreases in inpatient spending, which were only partially offset by increases in outpatient spending.
Obesity class 2 and 3 were the main factors driving spending increases, suggesting that persons over BMI of 35 should be the focus for policies focused on controlling spending, such as prevention.
In surgical settings, obesity led to higher average marginal total direct costs (9%), total facility costs (15%), and facility OR costs (22%), as well as 24 more OR minutes per surgery. Being overweight was associated with higher total facility (8%) and facility OR costs (12%), with 11 more OR minutes per surgery.
For individuals with comorbidities, normal weight individuals with diabetes, dyslipidemia, or hypertension had significantly greater medical expenditures than those without these conditions ($6,006, $4,760, $3,911 respectively). Obesity significantly exacerbated these costs ($7,986, $7,636, $6,197 respectively; all P < 0.05).
Diabetes, dyslipidemia, and hypertension resulted in greater missed work days (3.1, 3.2, 1.4 days respectively), with obesity significantly increasing missed work days (8.7, 5.5, 4.5 days). This resulted in greater lost productivity costs ($1,217, $763, $622) for obese individuals with these conditions.
In bariatric surgery patients who develop iron deficiency anemia (IDA), total costs were twice as much in the IDA group compared with the non-IDA group ($37,882 vs. $19,253). An estimated 150,000 to 160,000 bariatric surgeries are performed in the United States yearly.
European Economic Impact
Germany
In Germany, a study of older adults (58-82 years) found that for normal weight, overweight, obese class 1 and obese class ≥2 individuals, mean costs (3-month period) of outpatient care were €384, €435, €475 and €525 (P < 0.001). Mean costs of inpatient care were €284, €408, €333 and €652 (P = 0.070). Mean total costs were €716, €891, €852 and €1,244 (P = 0.013).
Multiple regression analyses showed a significant effect of obesity on costs of outpatient care (class 1: +€72; class ≥2: +€153) and total costs (class ≥2: +€361).
A cross-sectional health survey (KORA-Survey S4 1999/2001) of adults aged 25-74 in the Augsburg region found that respondents with severe obesity (BMI ≥35) had significantly higher direct medical costs (2,572.19 euro per annum) compared to those with normal weight (847.60 euro) or pre-obesity (830.59 euro).
For users of care in Germany, those with severe obesity had costs of 2,964.87 euro compared to 993.18 euro for normal weight and 1,003.23 euro for pre-obese individuals. The pattern of higher costs for severely obese individuals was largely due to inpatient days in hospital and prescription drugs.
Using the Differential Costs (DC)-Obesity model, individuals with obesity and low socioeconomic status (SES) had lifetime excess costs that were two times higher (€8,526) compared to those with obesity and high SES. In contrast, costs were 20% higher in groups with overweight and high SES than in groups with overweight and low SES (€2,711).
Spain
A Spanish study found that subjects who closely adhered to the Mediterranean Diet Score (MDS) and Healthy Eating Index (HEI), both inversely associated with BMI and obesity, paid daily 1.2 Euro (1.50$) and 1.4 Euro (1.75$) more for food consumption, respectively. An increase in 1 Euro (1.25$) of monetary diet costs per day was associated with a change of 0.46 units (P<0.001) and 2.03 units (P<0.001) in the MDS and HEI, respectively.
Turkey
In Turkey, which has the highest rate of overweight and obesity in Europe according to WHO, obesity-related complications constituted 28.87% of total costs in Segment A hospitals, 29.13% in Segment B hospitals, and 28.54% in Segment C hospitals. Weight loss dramatically reduced healthcare expenditures in obese patients, with Type 2 Diabetes Mellitus (T2DM) being the leading cause of costs in all age groups.
When obesity-related complications were stratified by weight loss rate (5%, 10%, and 20%), a higher cost reduction was observed in the 40-49, 50-59, and 60-69 age groups.
Ireland
In Ireland, a study of adults aged ≥50 found that 77.6% were overweight or obese, with all classes of obesity significantly associated with higher general practitioner service use. Moderate and severe obesity were associated with increased use of out-patient services and chiropody services (estimated annual cost of €919,662). Morbid obesity was associated with dietetic service use with an annual cost of €580,013.
Treatment Cost-Effectiveness
A cost-effectiveness study comparing endoscopic sleeve gastroplasty (ESG) with semaglutide found that ESG was more cost-effective over a 5-year time horizon, with an incremental cost-effectiveness ratio (ICER) of -$595,532/QALY. ESG added 0.06 quality-adjusted life-years (QALYs) and reduced total cost by $33,583 relative to semaglutide.
Drug used in other indications
ASC30 Clinical Trials Beyond Obesity
Based on the available information, there is no data regarding ASC30 clinical trials for indications other than obesity. The provided context does not contain any information about:
- Clinical indications beyond obesity for ASC30
- Intervention models or protocols for ASC30 trials
- Phase status of any ASC30 trials for metabolic disorders or other therapeutic areas
The context specifically indicates that after careful review, no information about ASC30 or any clinical trials it might be undergoing could be found in the provided materials.