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RecruitingNCT07539415Updated Jul 16, 2026

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 interventional study of DWRX5003 and DWC202502 in Obesity & Overweight and Type 2 Diabetes, sponsored by Daewoong Pharmaceutical Co. LTD.. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
19 Years to 64 Years
Sex
All
01

Study summary

Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults

02

Conditions studied

  • Obesity & Overweight
  • Type 2 Diabetes
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 72 is close to the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 200 studies on the registry; 33 are open to participants now.

Browse Daewoong Pharmaceutical Co. LTD. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 (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

Exclusion Criteria:

  1. Subjects with past or current medical history of 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 (e.g., anaphylaxis or angioedema) or clinically significant hypersensitivity to the active ingredient of the IP, pharmaceutical , 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 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    DWRX5003

    DWRX5003 3 doses

    Drug: DWRX5003

  • Active comparator
    DWC202502

    Drug: DWC202502

  • Active comparator
    DWC202503

    Drug: DWC202503

  • Placebo comparator
    DWRX5003P

    Other: DWRX5003P

Interventions

  • DrugDWRX5003

    Microneedle patch containing Semaglutide

  • DrugDWC202502

    Semagluide

  • DrugDWC202503

    Semaglutide

  • OtherDWRX5003P

    placebo microneedle patch

This study also gives Semaglutide. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. AUC 0-t

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

  2. Cmax

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

Secondary outcomes

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

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

  2. CL/F, Vd/F

    Clearance, Volume of distribution

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

  3. Tmax, t½

    Tmax (time to reach maximum plasma concentration), t½ (elimination half-life)

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

  4. Frel

    Relative bioavailability compared to the active control

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

Other outcomes

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

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

  2. Emax of glucose

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

  3. AUEC0-168h, AUEC0-672h of glucose

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

  4. body weight

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

  5. BMI

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

  6. waist circumference

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Oct 2026, 5 months after the start.

Of 334 industry-sponsored phase 1 interventional studies under Obesity, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's planned 5 months is below that.

Counting every sponsor, half of 439 studies reached it within 11 months; a quarter within 6 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2026
First posted
Apr 20, 2026
StartActual
May 6, 2026
Primary completionEst.
Oct 27, 2026
CompletionEst.
Nov 17, 2026
Last update
Jul 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07539415
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Apr 20, 2026
Start date
May 6, 2026
Primary completion
Oct 27, 2026 (estimated)
Completion
Nov 17, 2026 (estimated)
Last update
Jul 16, 2026

Study contacts

YeaRa Kwak
Contact
yeara.kwak@daewoong.co.kr
+8225508317

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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