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

Phase 1

Recruiting

• Conditions: Obesity; Type 2 Diabetes Mellitus
• Interventions: Drug: Oral ecnoglutide tablet; Drug: T2026; Drug: Placebo

• Registration Number: NCT05184322
• Lead Sponsor: Sciwind Biosciences APAC CO Pty. Ltd.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2022-01-06
• Study First Posted: 2022-01-11
• Study Start: 2022-04-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-28
• Primary Completion: 2024-07-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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);

Key

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 4	T2026	Cohort 4 will enroll 14 otherwise healthy participants with obesity.
Cohort 5	Oral ecnoglutide tablet	Cohort 5 will enroll 14 otherwise healthy participants with obesity.
Cohort 3	Oral ecnoglutide tablet	Cohort 3 will enroll 14 healthy participants.
Cohort 4	Placebo	Cohort 4 will enroll 14 otherwise healthy participants with obesity.
Cohort 4	Oral ecnoglutide tablet	Cohort 4 will enroll 14 otherwise healthy participants with obesity.
Cohort 1A/1B	Placebo	Cohort 1A/1B will enroll 14 healthy participants.
Cohort 2	T2026	Cohort 2 will enroll 14 healthy participants.
Cohort 5	T2026	Cohort 5 will enroll 14 otherwise healthy participants with obesity.
Cohort 6	Oral ecnoglutide tablet	Cohort 6 will enroll 14 otherwise healthy participants with obesity.
Cohort 1A/1B	T2026	Cohort 1A/1B will enroll 14 healthy participants.
Cohort 2	Placebo	Cohort 2 will enroll 14 healthy participants.
Cohort 3	T2026	Cohort 3 will enroll 14 healthy participants.
Cohort 3	Placebo	Cohort 3 will enroll 14 healthy participants.
Cohort 2	Oral ecnoglutide tablet	Cohort 2 will enroll 14 healthy participants.
Cohort 6	T2026	Cohort 6 will enroll 14 otherwise healthy participants with obesity.
Cohort 5	Placebo	Cohort 5 will enroll 14 otherwise healthy participants with obesity.
Cohort 1A/1B	Oral ecnoglutide tablet	Cohort 1A/1B will enroll 14 healthy participants.

Primary Outcome Measures

Name	Time	Method
Number and percentage of treatment emergent adverse events (TEAEs) and serious adverse events (SAE)	Up to 98 days	Count of adverse events

Trial Locations

Locations (1)

Q-Pharm Pty Ltd (AKA Nucleus Network Brisbane); 🇦🇺 Herston, Queensland, Australia