Healthy VolunteersPhase 1NCT06335134
A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin
A Phase 1 study testing XW003 injection, Metformin and Warfarin in people with Healthy Volunteers, run by Hangzhou Sciwind Biosciences Co., Ltd. at 1 site in China.
Trial summary
This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- XW003 injection, Metformin and Warfarin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2023to 28 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, 18-45 years old, inclusive;
- BMI: 20.0 to 30.0 kg/m2 , body weight: ≥50.0kg.
- Ability and willingness to participate in the study, give written informed consent, and comply with the study requirements and all protocol procedures.
Who cannot join
- 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);
- History of allergic diseases including asthma, urticaria or eczema, or history of sensitivity to GLP-1 products, digoxin, warfarin, rosuvastatin or metformin;
- Known difficulty in swallowing tablets or history of gastrointestinal diseases affecting drug absorption;
- History of receiving any procedures that might affect drug absorption, distribution, metabolism or excretion;
- History of acute or chronic pancreatitis;
- History of documented or suspected hypoglycemic episodes within 6 months prior to screening;
Trial locations and contacts
1 site in 1 country.
China1 site
West China Second University Hospital, Sichuan University
Chengdu, Sichuan
About this study
Official title: 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
This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin
Read the detailed description
This is a single-center, open-label, fixed-sequence study designed to assess the effect of once-weekly subcutaneous injections of XW003 on the pharmacokinetics of metformin, warfarin, rosuvastatin or digoxin. Approximately 56 healthy subjects are to be enrolled into 2 parallel trial groups, with 28 subjects and 2 drugs evaluated in each of the trial group
- Conditions
- Healthy Volunteers
- Being tested
- XW003 injection, Metformin, Warfarin, Rosuvastatin, Digoxin
- Keywords
- Ecnoglutide, XW003, Metformin, Warfarin, Rosuvastatin, Digoxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XW003 injectionDrug
Also called ecnoglutide
Administered subcutaneously
MetforminDrug
Administered orally
WarfarinDrug
Administered orally
RosuvastatinDrug
Administered orally
DigoxinDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment | Experimental | Metformin will be dosed twice daily (0.5 mg per dose) in two periods of 3.5 days for a total of 7 doses before and with XW003 treatment. Single doses of warfarin (2.5 mg per dose) will be given before and with XW003 treatment. The two drugs will be separated by a washout. XW003 will be administered subcutaneously once weekly in escalating doses of 0.3 mg for 4 weeks, 0.6 mg for 4 weeks and 1.2 mg for 4 weeks. Receives: Drug: XW003 injection; Drug: Metformin; Drug: Warfarin |
| Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment | Experimental | Single doses of rosuvastatin (10 mg per dose) and digoxin (0.25 mg per dose) will be given before and with XW003 treatment. The two drugs will be separated by a washout. XW003 will be administered subcutaneously once weekly in escalating doses of 0.3 mg for 4 weeks, 0.6 mg for 4 weeks and 1.2 mg for 4 weeks. Receives: Drug: XW003 injection; Drug: Rosuvastatin; Drug: Digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of metformin: AUC0-inf
Measured: up to 101 days
Pharmacokinetics of S-warfarin and R-warfarin: AUC0-inf
Measured: up to 114 days
Pharmacokinetics of rosuvastatin: AUC0-inf
Measured: up to 102 days
Pharmacokinetics of digoxin: AUC0-inf
Measured: up to 112days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start14 Jul 2023
- Primary completion8 Jan 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qin Yu, Principal investigator, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335134
- Sponsor's protocol ID
- SCW0502-1016
- Status last verified
- Jul 2023
- First submitted
- 29 Jul 2023
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06335134
- Acronym / sponsor ID
- SCW0502-1016
- Conditions
- Healthy Volunteers
- Keywords
- Ecnoglutide, XW003, Metformin, Warfarin, Rosuvastatin, Digoxin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin
Detailed description
This is a single-center, open-label, fixed-sequence study designed to assess the effect of once-weekly subcutaneous injections of XW003 on the pharmacokinetics of metformin, warfarin, rosuvastatin or digoxin. Approximately 56 healthy subjects are to be enrolled into 2 parallel trial groups, with 28 subjects and 2 drugs evaluated in each of the trial group
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment | Experimental | Drug: XW003 injection, Drug: Metformin, Drug: WarfarinMetformin will be dosed twice daily (0.5 mg per dose) in two periods of 3.5 days for a total of 7 doses before and with XW003 treatment. Single doses of warfarin (2.5 mg per dose) will be given before and with XW003 treatment. The two drugs will be separated by a washout. XW003 will be administered subcutaneously once weekly in escalating doses of 0.3 mg for 4 weeks, 0.6 mg for 4 weeks and 1.2 mg for 4 weeks. |
| Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment | Experimental | Drug: XW003 injection, Drug: Rosuvastatin, Drug: DigoxinSingle doses of rosuvastatin (10 mg per dose) and digoxin (0.25 mg per dose) will be given before and with XW003 treatment. The two drugs will be separated by a washout. XW003 will be administered subcutaneously once weekly in escalating doses of 0.3 mg for 4 weeks, 0.6 mg for 4 weeks and 1.2 mg for 4 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female, 18-45 years old, inclusive;
- BMI: 20.0 to 30.0 kg/m2 , body weight: ≥50.0kg.
- Ability and willingness to participate in the study, give written informed consent, and comply with the study requirements and all protocol procedures.
Key exclusion criteria (6 listed)
- 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);
- History of allergic diseases including asthma, urticaria or eczema, or history of sensitivity to GLP-1 products, digoxin, warfarin, rosuvastatin or metformin;
- Known difficulty in swallowing tablets or history of gastrointestinal diseases affecting drug absorption;
- History of receiving any procedures that might affect drug absorption, distribution, metabolism or excretion;
- History of acute or chronic pancreatitis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XW003 injectionAlso: ecnoglutideAdministered subcutaneously | Drug | Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment, Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment |
| MetforminAdministered orally | Drug | Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment |
| WarfarinAdministered orally | Drug | Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment |
| RosuvastatinAdministered orally | Drug | Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment |
| DigoxinAdministered orally | Drug | Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment |
Primary outcome
Pharmacokinetics of metformin: AUC0-inf
Time frame: up to 101 days
Pharmacokinetics of S-warfarin and R-warfarin: AUC0-inf
Time frame: up to 114 days
Pharmacokinetics of rosuvastatin: AUC0-inf
Time frame: up to 102 days
Pharmacokinetics of digoxin: AUC0-inf
Time frame: up to 112days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qin Yu principal investigator
West China Second University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XW003 injection, Metformin and Warfarin in people with Healthy Volunteers, run by Hangzhou Sciwind Biosciences Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of metformin: AUC0-inf (time frame: up to 101 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.