← Trials/Trial dossier/NCT05680129

CompletedPhase 3

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

Assets

Dulaglutide / Ecnoglutide (XW003)

Listed sites

1

Recruiting sites

Enrollment

623

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI 20-35HbA1c 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

NCT IDNCT05680129
Org study IDSCW0502-1032

Timeline

Milestones

Study start2023-01-10actual
Study first posted2023-01-11actual
Primary completion2024-07-03actual
Study completion2024-10-12actual
Last update posted2025-05-08actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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

Glycemic / diabetes
3
Weight & body composition
1
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change 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 endpoints
Primary/protocol endpoint

Change from baseline in HbA1c

Time frame:Baseline, week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint

Change from baseline in lipid panel

Time frame:Baseline, Week 32 and Week 52

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Pharmacokinetics: 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.

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.