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

NCT05184322 | Completed Phase 1 DMC

• 1 other identifier: SCW0503-1011
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Type 2 Diabetes Mellitus

Keywords

Obesity; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Number and percentage of treatment emergent adverse events (TEAEs) and serious adverse events (SAE)

  Count of adverse events

  Up to 98 days

Study Arms (6)

Cohort 1A/1B

EXPERIMENTAL

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

Drug: T2026; Drug: Placebo; Drug: Oral ecnoglutide tablet

Cohort 2

EXPERIMENTAL

Cohort 2 will enroll 14 healthy participants.

Drug: T2026; Drug: Placebo; Drug: Oral ecnoglutide tablet

Cohort 3

EXPERIMENTAL

Cohort 3 will enroll 14 healthy participants.

Drug: T2026; Drug: Placebo; Drug: Oral ecnoglutide tablet

Cohort 4

EXPERIMENTAL

Cohort 4 will enroll 14 otherwise healthy participants with obesity.

Drug: Oral ecnoglutide tablet; Drug: T2026; Drug: Placebo

Cohort 5

EXPERIMENTAL

Cohort 5 will enroll 14 otherwise healthy participants with obesity.

Drug: Oral ecnoglutide tablet; Drug: T2026; Drug: Placebo

Cohort 6

EXPERIMENTAL

Cohort 6 will enroll 14 otherwise healthy participants with obesity.

Drug: T2026; Drug: Oral ecnoglutide tablet

Interventions

T2026 DRUG

Once daily for 15 days.

Also known as: Absorption enhancer excipient

Cohort 1A/1B; Cohort 2; Cohort 3; Cohort 6

Placebo DRUG

Once daily for 15 days.

Cohort 1A/1B; Cohort 2; Cohort 3

Oral ecnoglutide tablet DRUG

Once daily for 6 weeks.

Also known as: GLP-1 analogue, XW004

Cohort 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sciwind Biosciences APAC CO Pty. Ltd.: lead
• Hangzhou Sciwind Biosciences Co., Ltd.: collaborator
• Sciwind Biosciences USA Co., Ltd.: collaborator

Study Sites (1)

Q-Pharm Pty Ltd (AKA Nucleus Network Brisbane)

Herston, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Richard Friend

  Nucleus Network Brisbane Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 11, 2022
• Study Start: April 12, 2022
• Primary Completion: July 13, 2024
• Study Completion: March 25, 2025
• Last Updated: September 10, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)