In short
ASC30 sodium is an investigational medicine being studied as a once-daily oral treatment for obesity and overweight, including people with type 2 diabetes. Two Phase 3 trials are currently authorised, together planning to enrol 4,371 participants. The trials measure the percent change in body weight from baseline to Week 72.
Key points
- ASC30 sodium is an investigational once-daily oral medicine for obesity and overweight.
- Two Phase 3 trials are authorised, with 1,560 and 2,811 planned participants.
- One trial focuses on obesity or overweight with type 2 diabetes mellitus; the other on obesity or overweight with weight-related comorbidities.
- The main goal in both trials is the percent change in body weight from baseline to Week 72.
- Both trials compare ASC30 sodium against placebo tablets.
- No marketing authorisation is mentioned in the available trial records.
What is ASC30 sodium?
ASC30 sodium is an investigational substance, meaning it has not been approved as a medicine in the records provided. It is being developed as a once-daily oral treatment for obesity and overweight, including people with type 2 diabetes mellitus. The available EU Clinical Trials Information System records describe ASC30 sodium only through its clinical trials; no trade name, development code history, or marketing authorisation is listed.
How does ASC30 sodium work?
The trial records do not describe a mechanism of action for ASC30 sodium, such as a molecular target or receptor. No supplementary sources were provided. The available data therefore cannot explain how ASC30 sodium might produce its effects. The trials measure whether the substance changes body weight over 72 weeks, but the biological pathway is not stated.
Which conditions is ASC30 sodium studied for?
- Obesity or overweight with type 2 diabetes mellitus — one Phase 3 trial studies people who have both excess body weight and type 2 diabetes.
- Obesity or overweight with weight-related comorbidities — a second Phase 3 trial includes people with obesity or overweight who also have other health problems linked to their weight.
How is ASC30 sodium given?
ASC30 sodium is given by mouth as a tablet, described in the trial records as an oral-use drug. The interventions list includes placebo tablets in two shapes, round biconvex and oval-shaped, while the ASC30 sodium tablets themselves are not described by shape in the records. One trial lists ASC30 sodium 60 mg as an intervention, while the other trial lists the dose as 0 mg, meaning the dose was not reported in that record.
What do the clinical trials show?
Two Phase 3 trials of ASC30 sodium are authorised in the EU Clinical Trials Information System. Both are interventional studies comparing once-daily oral ASC30 sodium with placebo. The main measure in both trials is the percent change in body weight from baseline to Week 72.
The first trial plans to enrol 1,560 participants with obesity or overweight and type 2 diabetes mellitus. Its stated aim is to demonstrate that one or more doses of once-daily oral ASC30 sodium are superior to placebo for body weight at 72 weeks.
The second trial plans to enrol 2,811 participants with obesity or overweight and weight-related comorbidities. Its stated aim is to demonstrate that pooled doses of once-daily oral ASC30 sodium are superior to placebo for body weight from baseline to Week 72.
Both trials are currently authorised, meaning they have received regulatory approval to proceed but have not yet reported results in the provided records. The trials do not list secondary outcomes, inclusion criteria, or exclusion criteria in the data provided.
What side effects are known?
The available trial records do not report side effects for ASC30 sodium, and no supplementary sources were provided. At this stage, no information on common or serious side effects is available from the data.