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CompletedPhase 1

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

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

NCT IDNCT05579314
Org study IDXW014-001

Timeline

Milestones

Study start2022-09-26actual
Study first posted2022-10-13actual
Primary completion2024-11-16actual
Study completion2024-11-16actual
Last update posted2025-09-19actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersAccepted

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 endpoints
Primary/protocol endpoint

Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)

Time frame:11 weeks

descriptive

Primary/protocol endpoint

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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.