NCT06335134

Brief Summary

This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2023

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2024

Completed
Last Updated

May 8, 2025

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

July 29, 2023

Last Update Submit

May 7, 2025

Conditions

Healthy Volunteers

Keywords

EcnoglutideXW003MetforminWarfarinRosuvastatinDigoxin

Outcome Measures

Primary Outcomes (4)

  • Pharmacokinetics of metformin: AUC0-inf

    up to 101 days

  • Pharmacokinetics of S-warfarin and R-warfarin: AUC0-inf

    up to 114 days

  • Pharmacokinetics of rosuvastatin: AUC0-inf

    up to 102 days

  • Pharmacokinetics of digoxin: AUC0-inf

    up to 112days

Study Arms (2)

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.

Drug: XW003 injectionDrug: MetforminDrug: 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.

Drug: XW003 injectionDrug: RosuvastatinDrug: Digoxin

Interventions

XW003 injectionDRUG

Administered subcutaneously

Also known as: ecnoglutide
Trial Group 1: Metformin and Warfarin administered before and with XW003 treatmentTrial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment
MetforminDRUG

Administered orally

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

Administered orally

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

Administered orally

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

Administered orally

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

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Interventions

MetforminWarfarinRosuvastatin CalciumDigoxin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSulfonamidesAmidesFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesDigitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • Qin Yu

    West China Second University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2023

First Posted

March 28, 2024

Study Start

July 14, 2023

Primary Completion

January 8, 2024

Study Completion

June 28, 2024

Last Updated

May 8, 2025

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)