Obesity & OverweightPhase 1NCT07539415
A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC202502 and DWC202503 in Healthy Adult Volunteers
A Phase 1 study testing DWRX5003, DWC202502 and DWC202503 in people with Obesity & Overweight and Type 2 Diabetes, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight, Type 2 Diabetes
- What is being tested?
- DWRX5003, DWC202502 and DWC202503
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 May 2026to 17 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers aged ≥ 19 and ≤ 65 years at screening
- 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
- Subjects with no congenital disease or chronic disease requiring treatment as well as no pathologic symptoms or findings based on medical examination
- 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
- 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
Who cannot join
- Subjects with past or current medical history of clinically significant hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematologic, oncologic, genitourinary, cardiovascular, digestive, and musculoskeletal diseases:
- Females who are pregnant (serum-HCG positive) or breast-feeding
- 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)
- 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
- Subjects with a history of acute or chronic pancreatitis
- Subjects with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2)
- Subjects who are deemed ineligible for participation in the study by the investigator for reasons other than the above inclusion/exclusion criteria etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Seongyeon Hong, Pharm D., +82-2-740-8872, syhongok@snu.ac.kr
About this study
Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults
- Conditions
- Obesity & Overweight, Type 2 Diabetes
- Being tested
- DWRX5003, DWC202502, DWC202503, DWRX5003P
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWRX5003Drug
Microneedle patch containing Semaglutide
DWC202502Drug
Semagluide
DWC202503Drug
Semaglutide
DWRX5003POther
placebo microneedle patch
| Study group | Role | What they receive |
|---|---|---|
| DWRX5003 | Experimental | DWRX5003 3 doses Receives: Drug: DWRX5003 |
| DWC202502 | Active comparator | Not described Receives: Drug: DWC202502 |
| DWC202503 | Active comparator | Not described Receives: Drug: DWC202503 |
| DWRX5003P | Placebo comparator | Not described Receives: Other: DWRX5003P |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0-t
Measured: Pre-dose (0 hour) up to 672 hours post-dose
Cmax
Measured: Pre-dose (0 hour) up to 672 hours post-dose
Secondary outcomes (4)
AUC 0-8h, AUC 0-168h, AUCinf
Measured: Pre-dose (0 hour) up to 672 hours post-dose
CL/F, Vd/F
Clearance, Volume of distribution
Measured: Pre-dose (0 hour) up to 672 hours post-dose
Tmax, t½
Tmax (time to reach maximum plasma concentration), t½ (elimination half-life)
Measured: Pre-dose (0 hour) up to 672 hours post-dose
Frel
Relative bioavailability compared to the active control
Measured: Pre-dose (0 hour) up to 672 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start6 May 2026
- Primary completion27 Oct 2026 (estimated)
- Study completion17 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539415
- Sponsor's protocol ID
- DW_DWRX5003101
- Status last verified
- Jul 2026
- First submitted
- 9 Feb 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC202502 and DWC202503 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07539415
- Acronym / sponsor ID
- DW_DWRX5003101
- Conditions
- Obesity & Overweight, Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 6 May 2026 (actual)
- Primary completion
- 27 Oct 2026 (estimated)
- Study completion
- 17 Nov 2026 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DWRX5003 | Experimental | Drug: DWRX5003DWRX5003 3 doses |
| DWC202502 | Active comparator | Drug: DWC202502 |
| DWC202503 | Active comparator | Drug: DWC202503 |
| DWRX5003P | Placebo comparator | Other: DWRX5003P |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult volunteers aged ≥ 19 and ≤ 65 years at screening
- 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
- Subjects with no congenital disease or chronic disease requiring treatment as well as no pathologic symptoms or findings based on medical examination
- 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
- 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
Key exclusion criteria (7 listed)
- Subjects with past or current medical history of clinically significant hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematologic, oncologic, genitourinary, cardiovascular, digestive, and musculoskeletal diseases:
- Females who are pregnant (serum-HCG positive) or breast-feeding
- 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)
- 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
- Subjects with a history of acute or chronic pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DWRX5003Microneedle patch containing Semaglutide | Drug | DWRX5003 |
| DWC202502Semagluide | Drug | DWC202502 |
| DWC202503Semaglutide | Drug | DWC202503 |
| DWRX5003Pplacebo microneedle patch | Other | DWRX5003P |
Primary outcome
AUC 0-t
Time frame: Pre-dose (0 hour) up to 672 hours post-dose
Cmax
Time frame: Pre-dose (0 hour) up to 672 hours post-dose
4 secondary outcomes
AUC 0-8h, AUC 0-168h, AUCinf
Time frame: Pre-dose (0 hour) up to 672 hours post-dose
CL/F, Vd/F
Time frame: Pre-dose (0 hour) up to 672 hours post-dose
Tmax, t½
Time frame: Pre-dose (0 hour) up to 672 hours post-dose
Frel
Time frame: Pre-dose (0 hour) up to 672 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DWRX5003, DWC202502 and DWC202503 in people with Obesity & Overweight and Type 2 Diabetes, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YeaRa Kwak (+8225508317, yeara.kwak@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC 0-t (time frame: Pre-dose (0 hour) up to 672 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.