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XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose Study to Assess Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
Lead sponsor
Asset
XW014
Oral · GLP-1 agonist
Listed sites
3
Recruiting sites
—
Enrollment
127
actual
Study population
Healthy volunteers, Obesity / overweight, Type 2 diabetes
Key I/E criterion
•HbA1c 6.5-8.5%
Primary endpoints
•Number and percentage of treatment emergent adverse events (TEAE)•Clinical laboratory values, vital signs
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Eligibility criteria
1. Ability and willingness to participate in the study, give written informed consent, and comply with the study restrictions and all protocol procedures
2. Sex: male or female
3. Weight: >50 kg, inclusive, at screening
4. Age:
1. For Part A 18 to 70 years, inclusive, at screening
2. For Part B, Part B-EXT, and C 18 to 55 years, inclusive, at screening
5. Body Mass Index
1. For Part A: ≥18.5 kg/m2 and ≤35.0 kg/m2, inclusive, at screening
2. For Part B and Part B-EXT: ≥30.0 kg/m2 and ≤40.0 kg/m2, inclusive, at screening
3. For Part C: ≥25.0 kg/m2 and ≤40.0 kg/m2, inclusive, at screening
6. Patients with T2DM for at least 6 months, having HbA1c of 6.5% to 8.5% (Part C)
Key Exclusion Criteria:
1. History or clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurologic, renal, pancreatic, immunologic, dermatologic, endocrine, genitourinary, or hematologic system
2. Uncontrolled hypertension
3. History of type 1 diabetes mellitus
4. History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis
5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 or subjects with suspected medullary thyroid carcinoma
6. Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of the investigational product
Endpoints (2)
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.
Safety / tolerability / PK
2 endpointsNumber and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)
Time frame:11 weeks
descriptive
Mean change from baseline in clinical laboratory values, vital signs, clinical findings from physical exam and ECG abnormalities
Time frame:11 weeks
change from baseline, event
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 1, 2026 snapshot.