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

Last updated: June 26, 2024
Sponsor: Sciwind Biosciences APAC CO Pty. Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Diabetes Mellitus, Type 2

Obesity

Diabetes Prevention

Treatment

T2026

Oral ecnoglutide tablet

Placebo

Clinical Study ID

NCT05184322
SCW0503-1011
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Healthy male or female participants, aged 18 to 55 years (inclusive at the time ofinformed consenting);

  • Participants must be in good general health, with no significant medical history,and have no clinically significant abnormalities on physical examination atScreening and/or before administration of study drug;

  • Stable body weight for at least 3 months prior to Screening (i.e., <5% change) byself-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 ≥30.0kg/m2 and <40.0 kg/m2 and weigh ≥75 kg at Screening (Cohort 4, 5 and 6 only);

Exclusion

Key Exclusion Criteria:

  • Prior or ongoing medical conditions, medical history, physical findings, orlaboratory abnormality that, in the Investigator's (or delegate's) opinion, mayrequire treatment or render the participant unlikely to fully complete the study, orany condition that presents undue risk from the investigational product (IP) orprocedures or interfere with study assessments;

  • Confirmed diagnosis of diabetes mellitus type 1, type 2, or of any other forms atany 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 endocrineneoplasia type 2;

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: T2026
Phase: 1
Study Start date:
April 12, 2022
Estimated Completion Date:
August 01, 2024

Study 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.

Connect with a study center

  • Q-Pharm Pty Ltd

    Brisbane, Queensland 4006
    Australia

    Site Not Available

  • Q-Pharm Pty Ltd (AKA Nucleus Network Brisbane)

    Herston, Queensland 4006
    Australia

    Active - Recruiting

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