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RecruitingPhase 1, PHASE2

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

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

NCT IDNCT07243171
Org study IDSCW0503-1012

Timeline

Milestones

Study start2025-11-18actual
Study first posted2025-11-21actual
Last update posted2026-01-28actual
Primary completion2026-08-03estimated
Study completion2026-11-22estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

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
Safety / tolerability / PK
3
Glycemic / diabetes
2
Cardiometabolic biomarkers
1

Weight & body composition

6 endpoints
Secondary/protocol endpoint

Change of body weight from baseline

Time frame:up to day 204

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change of BMI from baseline

Time frame:up to day 204

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change of waist circumference from baseline

Time frame:up to day 204

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change of hip circumference from baseline

Time frame:up to day 204

change from baseline, improvement

Secondary/protocol endpoint

Change of neck circumference from baseline

Time frame:up to day 204

change from baseline, improvement

Secondary/protocol endpoint

Change of waist/hip ratio from baseline

Time frame:up to day 204

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change of fasting blood glucose from baseline

Time frame:up to day 204

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change of fasting insulin from baseline

Time frame:up to day 204

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change of lipid profile from baseline

Time frame:up to day 204

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

The incidence and severity of adverse events

Time frame:up to day 204

Treatment-emergent AEs (any)

descriptive, event

Secondary/protocol endpoint

Pharmacokinetics of oral ecnoglutide tablet

Time frame:up to day 204

concentration, descriptive

Other/protocol endpoint

Immunogenecity of oral ecnoglutide tablet

Time frame:up to day 204

Immunogenicity (ADA)

descriptive

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.