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Delfa

← All trials/NCT07539415

Not yet recruitingPhase 1

A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC202502 and DWC202503 in Healthy Adult Volunteers

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

-

Estimated enrollment

72

Study population

Healthy volunteers

Eligibility highlights

BMI 20-29.9Healthy volunteers

Primary endpoints

AUC 0-tCmax

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

NCT IDNCT07539415
Org study IDDW_DWRX5003101

Timeline

Milestones

Study start2026-03-30estimated
Study first posted2026-04-20actual
Last update posted2026-04-20actual
Primary completion2026-04-30estimated
Study completion2026-08-30estimated

Assets

Investigational agents

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age19 Years
Maximum age64 Years
SexAll
Healthy volunteersAccepted

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

Safety / tolerability / PK
6
Weight & body composition
3
Glycemic / diabetes
3

Weight & body composition

3 endpoints
Other/protocol endpoint

body weight

Time frame:baseline (day -1 ) to day 29

change from baseline, improvement

Other/protocol endpoint

BMI

Time frame:baseline (day -1 ) to day 29

BMI, change

change from baseline, improvement

Other/protocol endpoint

waist circumference

Time frame:baseline (day -1 ) to day 29

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Other/protocol endpoint/low confidence

AUEC0-5h, AUEC5-10h, iAUC0-5h, iAUC5-10h

Time frame:Baseline (Day -1) to Day 8

descriptive

Other/protocol endpoint/low confidence

Emax of glucose

Time frame:Baseline (Day -1) to Day 8

descriptive

Other/protocol endpoint/low confidence

AUEC0-168h, AUEC0-672h of glucose

Time frame:Baseline (Day -1) to Day 8

descriptive

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

AUC 0-t

Time frame:Pre-dose (0 hour) up to 672 hours post-dose

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Cmax

Time frame:Pre-dose (0 hour) up to 672 hours post-dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC 0-8h, AUC 0-168h, AUCinf

Time frame:Pre-dose (0 hour) up to 672 hours post-dose

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

CL/F, Vd/F

Time frame:Pre-dose (0 hour) up to 672 hours post-dose

descriptive

Secondary/protocol endpoint

Tmax, t½

Time frame:Pre-dose (0 hour) up to 672 hours post-dose

descriptive

Secondary/protocol endpoint

Frel

Time frame:Pre-dose (0 hour) up to 672 hours post-dose

ratio, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.