XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults

NCT05184322 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2025-09-10

No results posted yet for this study

Summary

XW004 is an acylated human glucagon-like peptide 1 (GLP-1) analogue and is being developed for type 2 diabetes mellitus (T2DM) and obesity management.

Conditions

Interventions

DRUG

T2026

Once daily for 15 days.

DRUG

Placebo

Once daily for 15 days.

DRUG

Oral ecnoglutide tablet

Once daily for 6 weeks.

DRUG

Oral ecnoglutide tablet

Once daily and titrated up in concentration to once every week during maintenance period.

DRUG

Oral ecnoglutide tablet

Once daily for 15 days.

DRUG

Oral ecnoglutide tablet

Once daily for 15 days.

DRUG

Oral ecnoglutide tablet

Once daily for 15 days.

DRUG

Oral ecnoglutide tablet

Once daily for 15 days.

DRUG

T2026

Once daily for 6 weeks.

DRUG

Placebo

Once daily for 6 weeks.

DRUG

T2026

Once daily to once weekly for 12 weeks.

DRUG

Placebo

Once daily to once weekly for 12 weeks.

Sponsors & Collaborators

  • Hangzhou Sciwind Biosciences Co., Ltd.

    collaborator INDUSTRY
  • Sciwind Biosciences USA Co., Ltd.

    collaborator INDUSTRY
  • Sciwind Biosciences APAC CO Pty. Ltd.

    lead INDUSTRY

Principal Investigators

  • Richard Friend · Nucleus Network Brisbane Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-12
Primary Completion
2024-07-13
Completion
2025-03-25

Countries

  • Australia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05184322 on ClinicalTrials.gov