← Trials/Trial dossier/NCT05680155
A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients
A Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of XW003 in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone
Lead sponsor
Asset
Ecnoglutide (XW003)
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
211
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 T2DMthat is inadequately controlled with at least 3 months of diet and exercise 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 any GLP-1 analogue during the 3 months preceding to screening.
3. History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months preceding 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 (17)
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
3 endpointsChange from baseline in body weight
Time frame:Baseline, Week 24 and Week 52
Body weight, absolute change (kg)
change from baseline, improvement
Change from baseline in waist circumference
Time frame:Baseline, Week 24 and Week 52
Waist circumference, change
change from baseline, improvement
Change from baseline in hip circumference
Time frame:Baseline, Week 24 and Week 52
change from baseline, improvement
Glycemic / diabetes
10 endpointsChange from baseline in HbA1c
Time frame:Baseline, Week 24
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 29, Week 33, Week 37, Week 45, Week 52
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Proportion of subjects with HbA1c < 7% and HbA1c ≤6.5% after treatment
Time frame:week 24, week 52
HbA1c <7.0% achievement
threshold achievement, improvement
componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement
LOINC 4548-4
Proportion of subjects with HbA1c < 7%, with no severe hypoglycemia or no weight gain
Time frame:week 24
HbA1c <7.0% achievement
threshold achievement, improvement
componentsHbA1c <7.0% achievement, Severe hypoglycemia, Body weight, absolute change (kg)
LOINC 4548-4
Change from baseline in fasting plasma glucose (FPG)
Time frame:Baseline, Week 24 and Week 52
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change from baseline in fasting insulin
Time frame:Baseline, Week 24 and Week 52
change from baseline, improvement
Change from baseline in 2-hour postprandial blood glucose
Time frame:Baseline, Week 24 and Week 52
Postprandial glucose
change from baseline, improvement
Change from baseline in 7-point self-monitored blood glucose
Time frame:Baseline, Week 24 and Week 52
change from baseline, improvement
Change from baseline in HOMA-IR
Time frame:Baseline, Week 24 and Week 52
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Change from baseline in HOMA-β
Time frame:Baseline, Week 24 and Week 52
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointChange from baseline in lipid panel
Time frame:Baseline, Week 24 and Week 52
change from baseline, improvement
Safety / tolerability / PK
3 endpointsIncidence of adverse events
Time frame:from baseline to EOS
Treatment-emergent AEs (any)
event count, event
Pharmacokinetics: plasma trough level of XW003
Time frame:Baseline, D29, D57, D85, D168, D197, D225, D253, D364, D399
Plasma concentration (steady state)
concentration, descriptive
Immunogenecity of XW003
Time frame:Baseline, D85, D168, D253, D399
Immunogenicity (ADA)
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
- Nature communications2026 Jan 7PMID41501026doi:10.1038/s41467-025-68165-7via 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.