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A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM
A Phase 3, Multi-center, Open-label, Randomized Study to Evaluate the Efficacy and Safety of XW003 Versus Dulaglutide in Patients With T2DM Inadequately Controlled by Metformin
Lead sponsor
Assets
Dulaglutide / Ecnoglutide (XW003)
Listed sites
1
Recruiting sites
—
Enrollment
623
actual
Study population
Type 2 diabetes
Key I/E criteria
•BMI 20-35•HbA1c 7.5-11%
Primary endpoint
•HbA1c, change
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
Inclusion criteria
1. Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures
2. Sex: male or female; Age: 18 to 75 years, inclusive
3. BMI: 20.0 kg/m^2 to 35.0 kg/m^2, inclusive
4. Have been diagnosed with T2DM for at least 3 months and treated with a stable dose of metformin (≥1500 mg/day) in addition to diet and exercise during the 8 weeks prior to screening.
5. HbA1c ranging from 7.5% to 11.0% at screening, inclusive
6. FPG ≤13.9 mmol/L at screening
Exclusion criteria
1. History of type 1 or other types of diabetes mellitus
2. Use of insulin during the 6 months preceding screening
3. History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to screening.
4. History of acute or chronic pancreatitis or high-risk factors for pancreatitis
5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
6. History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months.
7. History of heart attack, stroke or congestive heart failure of Grade 3 or 4 in the past 6 months.
Endpoints (6)
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.
Coverage by outcome category
Weight & body composition
1 endpointChange from baseline in body weight
Time frame:Baseline, Week 32 and Week 52
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
3 endpointsChange from baseline in HbA1c
Time frame:Baseline, week 32
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change from baseline in HbA1c
Time frame:Baseline, Week 5, Week 9, Week 13, Week 17, Week 25, Week 43 and Week 52
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change from baseline in fasting plasma glucose (FPG)
Time frame:Baseline, Week 32 and Week 52
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Cardiometabolic biomarkers
1 endpointChange from baseline in lipid panel
Time frame:Baseline, Week 32 and Week 52
change from baseline, improvement
Safety / tolerability / PK
1 endpointPharmacokinetics: plasma trough level of XW003
Time frame:Baseline, Day 29, Day 57, Day 85, Day 224, Day 364 and Day 399
Plasma concentration (steady state)
concentration, descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- The lancet. Diabetes & endocrinology2025 Oct (month)PMID40854315doi:10.1016/S2213-8587(25)00196-2via clinicaltrials gov reference derived + pubmed nct search
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.