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CompletedNCT06335134Updated May 8, 2025

A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin

A Phase 1 interventional study of XW003 injection and Metformin in Healthy Volunteers, sponsored by Hangzhou Sciwind Biosciences Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-08.

Sponsored by Hangzhou Sciwind Biosciences Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
57
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Ecnoglutide
  • XW003
  • Metformin
  • Warfarin
  • Rosuvastatin
  • Digoxin
03

In context

Lead sponsor

Hangzhou Sciwind Biosciences Co., Ltd. is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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;
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment

    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.

    Drug: XW003 injection · Drug: Metformin · Drug: Warfarin

  • Experimental
    Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment

    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.

    Drug: XW003 injection · Drug: Rosuvastatin · Drug: Digoxin

Interventions

  • DrugXW003 injection

    Administered subcutaneously

    Also known as: ecnoglutide

  • DrugMetformin

    Administered orally

  • DrugWarfarin

    Administered orally

  • DrugRosuvastatin

    Administered orally

  • DrugDigoxin

    Administered orally

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics of metformin: AUC0-inf

    Time frame: up to 101 days

  2. Pharmacokinetics of S-warfarin and R-warfarin: AUC0-inf

    Time frame: up to 114 days

  3. Pharmacokinetics of rosuvastatin: AUC0-inf

    Time frame: up to 102 days

  4. Pharmacokinetics of digoxin: AUC0-inf

    Time frame: up to 112days

07

Study locations

1 site
  • West China Second University Hospital, Sichuan University
    Chengdu, Sichuan, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06335134
Lead sponsor
Hangzhou Sciwind Biosciences Co., Ltd.
Responsible party
Sponsor
First posted
Mar 28, 2024
Start date
Jul 14, 2023
Primary completion
Jan 8, 2024
Completion
Jun 28, 2024
Last update
May 8, 2025

Study contacts

Qin Yu
principal investigator · West China Second University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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