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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of ASC30 Tablets and ASC30 Tablets A1 in Participants With Obesity
A Phase I Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASC30 Tablets in Participants With Obesity
Lead sponsor
Asset
ASC30
Oral · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
72
actual
Study population
Obesity / overweight
Key I/E criterion
—
Primary endpoints
•AEs, SAEs of ASC30 (SAD)•AEs, SAEs of ASC30 (MAD)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Have provided informed consent before initiation of any study-specific procedures.
2. Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive).
3. No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.
Exclusion criteria
1. Have evidence of any clinically significant active or chronic disease.
2. Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or rare forms of diabetes mellitus.
3. Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
4. Have a history of acute or chronic pancreatitis.
5. Participants with a known clinically significant gastric emptying abnormality.
6. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
7. Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.
Endpoints (5)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointChange From Baseline in Body Weight (MAD)
Time frame:Up to Day 28
change from baseline, improvement
Safety / tolerability / PK
4 endpointsIncidence of AEs, SAEs (Safety and Tolerability) of ASC30 (SAD)
Time frame:Up to Day 8
event count, event
Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (MAD)
Time frame:Up to Day 28
event count, event
Cmax of ASC30 (SAD)
Time frame:Up to Day 8
concentration, descriptive
Cmax of ASC30 (MAD)
Time frame:Up to Day 28
concentration, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.