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A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin
A Single-Center, Open-Label Study to Evaluate the Effect of XW003 Injection on the Pharmacokinetics of Metformin, Warfarin, Rosuvastatin or Digoxin in Healthy Subjects
Lead sponsor
Asset
Ecnoglutide (XW003)
GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
57
actual
Study population
Healthy volunteers
Key I/E criterion
•BMI 20-30
Primary endpoints
•Pharmacokinetics of metformin•Pharmacokinetics of S-warfarin and R-warfarin•Pharmacokinetics of rosuvastatin
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. Male or female, 18-45 years old, inclusive;
2. BMI: 20.0 to 30.0 kg/m2 , body weight: ≥50.0kg.
3. Ability and willingness to participate in the study, give written informed consent, and comply with the study requirements and all protocol procedures.
Exclusion criteria
1. Presence of clinically significant conditions (including but not limited to respiratory system, cardiovascular system, gastrointestinal system, endocrine system, immune system, integumentary system, nervous system, ENT or other related diseases);
2. History of allergic diseases including asthma, urticaria or eczema, or history of sensitivity to GLP-1 products, digoxin, warfarin, rosuvastatin or metformin;
3. Known difficulty in swallowing tablets or history of gastrointestinal diseases affecting drug absorption;
4. History of receiving any procedures that might affect drug absorption, distribution, metabolism or excretion;
5. History of acute or chronic pancreatitis;
6. History of documented or suspected hypoglycemic episodes within 6 months prior to screening;
Endpoints (4)
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.
Safety / tolerability / PK
4 endpointsPharmacokinetics of metformin: AUC0-inf
Time frame:up to 101 days
AUC₀–∞
concentration, descriptive
Pharmacokinetics of S-warfarin and R-warfarin: AUC0-inf
Time frame:up to 114 days
AUC₀–∞
concentration, descriptive
Pharmacokinetics of rosuvastatin: AUC0-inf
Time frame:up to 102 days
AUC₀–∞
concentration, descriptive
Pharmacokinetics of digoxin: AUC0-inf
Time frame:up to 112days
AUC₀–∞
concentration, 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.