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A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
A Multicenter, Multiple-dose Escalation, Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
Lead sponsor
Asset
Ecnoglutide (XW004)
Oral · GLP-1 agonist
Listed sites
1
Recruiting sites
1
Enrollment
84
estimated
Study population
Obesity / overweight
Key I/E criterion
•BMI 24-35
Primary endpoint
•Treatment-emergent AEs (any)
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. At the time of informed consent, with BMI in the range of 24.0 to 35.0 kg/m2 (including the threshold), body weight >60.0 kg for male, and weight >50.0 kg for female;
2. Self-declaration of body weight change <5% within 3 months prior to informed consent ;
Exclusion criteria
1. Diagnosis of overweight or obesity due to endocrine disorders , such as Cushing's syndrome;
2. Diagnosis of other endocrine disorders with clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging shows TI-RADS≥ class 3), thyroid cancer, or personal or family history of type 2 multiple endocrine tumor syndrome (MEN2), etc.
3. Diagnosis of cardiovascular or cerebrovascular diseases with clinical significance within 6 months prior to screening, including but not limited to acute stroke, acute coronary syndrome, heart failure, arrhythmia, etc.
4. Diagnosis of severe gastrointestinal diseases, including but not limited to inflammatory bowel disease, active ulcers, irritable bowel syndrome, celiac disease, dyspepsia, diabetic gastroparesis, diabetic diarrhea, clinical gastric emptying abnormalities (such as pyloric obstruction), etc.
5. History of major gastrointestinal surgery (except cholecystectomy or appendectomy), or metabolic surgery, or plan to undergo major surgery during the study period;
6. HbA1c ≥6.5% or fasting blood glucose ≥7.0 mmol/L, or OGTT 2-hour blood glucose ≥11.1 mmol/L, at screening;
7. Clinical laboratory test results with clinical significance
Endpoints (12)
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
6 endpointsChange of body weight from baseline
Time frame:up to day 204
Body weight, absolute change (kg)
change from baseline, improvement
Change of BMI from baseline
Time frame:up to day 204
BMI, change
change from baseline, improvement
Change of waist circumference from baseline
Time frame:up to day 204
Waist circumference, change
change from baseline, improvement
Change of hip circumference from baseline
Time frame:up to day 204
change from baseline, improvement
Change of neck circumference from baseline
Time frame:up to day 204
change from baseline, improvement
Change of waist/hip ratio from baseline
Time frame:up to day 204
change from baseline, improvement
Glycemic / diabetes
2 endpointsChange of fasting blood glucose from baseline
Time frame:up to day 204
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change of fasting insulin from baseline
Time frame:up to day 204
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointChange of lipid profile from baseline
Time frame:up to day 204
change from baseline, improvement
Safety / tolerability / PK
3 endpointsThe incidence and severity of adverse events
Time frame:up to day 204
Treatment-emergent AEs (any)
descriptive, event
Pharmacokinetics of oral ecnoglutide tablet
Time frame:up to day 204
concentration, descriptive
Immunogenecity of oral ecnoglutide tablet
Time frame:up to day 204
Immunogenicity (ADA)
descriptive
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.