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

NCT ID: NCT05184322

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-12
• Study Completion Date: 2025-03-25

Brief 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.

Detailed Description

This is a single centre, double-blind, randomised, multiple-dose, placebo-controlled study, including six cohorts (Cohorts 1A/1B, 2, 3, 4, 5, 6) with a semi-parallel design. The study is designed to evaluate the safety, tolerability, PK, and PD of oral ecnoglutide tablet in healthy participants. Participants will undergo a Screening period beginning up to 28 days (Cohort 1 to 4) and 42 days (Cohort 5 and 6 ) prior to randomisation/dose administration and will be required to sign an informed consent form (ICF) before undertaking any study specific procedures or assessments. Participants who meet all of the inclusion and none of the exclusion criteria will be enrolled. Eligible participants will be admitted to the CRU on Day -1 for review of inclusion and exclusion criteria prior to the start of study procedures on Day 1. A Safety Review Committee (SRC) will be established to monitor the progress of this trial and to make recommendations on whether to continue, modify or stop the trial for safety or ethical reasons.

Conditions

Obesity; Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1A/1B

Cohort 1A/1B will enroll 14 healthy participants.

Group Type: EXPERIMENTAL

T2026

Intervention Type: DRUG

Once daily for 15 days.

Placebo

Intervention Type: DRUG

Once daily for 15 days.

Oral ecnoglutide tablet

Intervention Type: DRUG

Once daily for 15 days.

Cohort 2

Cohort 2 will enroll 14 healthy participants.

Group Type: EXPERIMENTAL

T2026

Intervention Type: DRUG

Once daily for 15 days.

Placebo

Intervention Type: DRUG

Once daily for 15 days.

Oral ecnoglutide tablet

Intervention Type: DRUG

Once daily for 15 days.

Cohort 3

Cohort 3 will enroll 14 healthy participants.

Group Type: EXPERIMENTAL

T2026

Intervention Type: DRUG

Once daily for 15 days.

Placebo

Intervention Type: DRUG

Once daily for 15 days.

Oral ecnoglutide tablet

Intervention Type: DRUG

Once daily for 15 days.

Cohort 4

Cohort 4 will enroll 14 otherwise healthy participants with obesity.

Group Type: EXPERIMENTAL

Oral ecnoglutide tablet

Intervention Type: DRUG

Once daily for 6 weeks.

T2026

Intervention Type: DRUG

Once daily for 6 weeks.

Placebo

Intervention Type: DRUG

Once daily for 6 weeks.

Cohort 5

Cohort 5 will enroll 14 otherwise healthy participants with obesity.

Group Type: EXPERIMENTAL

Oral ecnoglutide tablet

Intervention Type: DRUG

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

T2026

Intervention Type: DRUG

Once daily to once weekly for 12 weeks.

Placebo

Intervention Type: DRUG

Once daily to once weekly for 12 weeks.

Cohort 6

Cohort 6 will enroll 14 otherwise healthy participants with obesity.

Group Type: EXPERIMENTAL

T2026

Intervention Type: DRUG

Once daily for 15 days.

Oral ecnoglutide tablet

Intervention Type: DRUG

Once daily for 15 days.

Interventions

T2026

Once daily for 15 days.

Intervention Type: DRUG

Placebo

Once daily for 15 days.

Intervention Type: DRUG

Oral ecnoglutide tablet

Once daily for 6 weeks.

Intervention Type: DRUG

Oral ecnoglutide tablet

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

Intervention Type: DRUG

Oral ecnoglutide tablet

Once daily for 15 days.

Intervention Type: DRUG

Oral ecnoglutide tablet

Once daily for 15 days.

Intervention Type: DRUG

Oral ecnoglutide tablet

Once daily for 15 days.

Intervention Type: DRUG

Oral ecnoglutide tablet

Once daily for 15 days.

Intervention Type: DRUG

T2026

Once daily for 6 weeks.

Intervention Type: DRUG

Placebo

Once daily for 6 weeks.

Intervention Type: DRUG

T2026

Once daily to once weekly for 12 weeks.

Intervention Type: DRUG

Placebo

Once daily to once weekly for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

Absorption enhancer excipient; GLP-1 analogue; XW004; GLP-1 analogue; XW004; GLP-1 analogue; XW004; GLP-1 analogue; XW004; GLP-1 analogue; XW004; GLP-1 analogue; XW004; Absorption enhancer excipient; Absorption enhancer excipient

Eligibility Criteria

Inclusion Criteria

• Healthy male or female participants, aged 18 to 55 years (inclusive at the time of informed consenting);
• Participants must be in good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before administration of study drug;
• Stable body weight for at least 3 months prior to Screening (i.e., <5% change) by self-declaration;
• Participants must have a Body Mass Index (BMI) ≥22.0 kg/m2 and <32.0 kg/m2 and weigh ≥55 kg at Screening (Cohorts 1A/1B to 3), or participants must have a BMI ≥30.0 kg/m2 and <40.0 kg/m2 and weigh ≥75 kg at Screening (Cohort 4, 5 and 6 only);

Exclusion Criteria

• Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, may require treatment or render the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product (IP) or procedures or interfere with study assessments;
• Confirmed diagnosis of diabetes mellitus type 1, type 2, or of any other forms at any time, and/or occurrence of documented or suspected hypoglycaemic episodes within 12 months prior to Screening;
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hangzhou Sciwind Biosciences Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sciwind Biosciences USA Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sciwind Biosciences APAC CO Pty. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Friend

Role: PRINCIPAL_INVESTIGATOR

Nucleus Network Brisbane Clinic

Locations

Q-Pharm Pty Ltd (AKA Nucleus Network Brisbane)

Herston, Queensland, Australia

Countries

Australia

Other Identifiers

SCW0503-1011

Identifier Type: -

Identifier Source: org_study_id