A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC202502 and DWC202503 in Healthy Adult Volunteers
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
1
Recruiting sites
-
Estimated enrollment
72
Study population
Healthy volunteers
Eligibility highlights
•BMI 20-29.9•Healthy volunteers
Primary endpoints
•AUC 0-t•Cmax
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
1. Healthy adult volunteers aged ≥ 19 and ≤ 65 years at screening
2. Subjects with a body weight ≥ 50.0 kg to ≤ 100.0 kg and a BMI of ≥ 20.0 kg/m2 to ≤ 29.9 kg/m2 at screening
3. Subjects with no congenital disease or chronic disease requiring treatment as well as no pathologic symptoms or findings based on medical examination
4. Subjects who are determined to be eligible for this study based on results of laboratory tests, vital signs, physical examination, 12-lead electrocardiogram (ECG), etc. set and performed according to the nature of the IP at screening
5. Subjects who voluntarily decided to participate in the study and provided written consent to follow subject compliance requirements during the study after receiving a detailed explanation on this study and fully understanding the information
Exclusion criteria
1. Subjects with past or current medical history of clinically significant hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematologic, oncologic, genitourinary, cardiovascular, digestive, and musculoskeletal diseases:
2. Females who are pregnant (serum-HCG positive) or breast-feeding
3. Subjects with a history of hypersensitivity (e.g., anaphylaxis or angioedema) or clinically significant hypersensitivity to the active ingredient of the IP, pharmaceutical excipients, or other drugs (e.g., GLP-1 receptor agonists)
4. Subjects with a history of skin disease (e.g., burns, skin cancer, etc.) or skin transplant surgery that could affect the absorption of the investigational product
5. Subjects with a history of acute or chronic pancreatitis
6. Subjects with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2)
7. Subjects who are deemed ineligible for participation in the study by the investigator for reasons other than the above inclusion/exclusion criteria etc.
Endpoints (12)
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
3 endpointsbody weight
Time frame:baseline (day -1 ) to day 29
change from baseline, improvement
BMI
Time frame:baseline (day -1 ) to day 29
BMI, change
change from baseline, improvement
waist circumference
Time frame:baseline (day -1 ) to day 29
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
3 endpointsAUEC0-5h, AUEC5-10h, iAUC0-5h, iAUC5-10h
Time frame:Baseline (Day -1) to Day 8
descriptive
Emax of glucose
Time frame:Baseline (Day -1) to Day 8
descriptive
AUEC0-168h, AUEC0-672h of glucose
Time frame:Baseline (Day -1) to Day 8
descriptive
Safety / tolerability / PK
6 endpointsAUC 0-t
Time frame:Pre-dose (0 hour) up to 672 hours post-dose
AUC₀-∞
concentration, descriptive
Cmax
Time frame:Pre-dose (0 hour) up to 672 hours post-dose
Cmax
concentration, descriptive
AUC 0-8h, AUC 0-168h, AUCinf
Time frame:Pre-dose (0 hour) up to 672 hours post-dose
AUC₀-∞
concentration, descriptive
CL/F, Vd/F
Time frame:Pre-dose (0 hour) up to 672 hours post-dose
descriptive
Tmax, t½
Time frame:Pre-dose (0 hour) up to 672 hours post-dose
descriptive
Frel
Time frame:Pre-dose (0 hour) up to 672 hours post-dose
ratio, 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 6, 2026 snapshot.