| Trial ID: | L3520 |
| Source ID: | NCT05579314
|
| Associated Drug: |
Xw014
|
| Title: |
XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
|
| Acronym: |
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: XW014|DRUG: Placebo|DRUG: XW014|DRUG: Placebo
|
| Outcome Measures: |
Primary: Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE), 11 weeks|Mean change from baseline in clinical laboratory values, vital signs, clinical findings from physical exam and ECG abnormalities, 11 weeks |
|
| Sponsor/Collaborators: |
Sponsor: Sciwind Biosciences USA Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
152
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-09-26
|
| Completion Date: |
2025-03-01
|
| Results First Posted: |
|
| Last Update Posted: |
2024-12-24
|
| Locations: |
ICON - Early Development Services, Lenexa, Kansas, 66219, United States|ICON - Early Development Services, San Antonio, Texas, 78209, United States|ICON - Early Development Services, Salt Lake City, Utah, 84124, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05579314
|
