Status:
COMPLETED
XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults
Lead Sponsor:
Sciwind Biosciences APAC CO Pty. Ltd.
Collaborating Sponsors:
Hangzhou Sciwind Biosciences Co., Ltd.
Sciwind Biosciences USA Co., Ltd.
Conditions:
Obesity
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 e...
Eligibility Criteria
Inclusion
- Key
- 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
Exclusion
- 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;
Key Trial Info
Start Date :
April 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2025
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT05184322
Start Date
April 12 2022
End Date
March 25 2025
Last Update
September 10 2025
Active Locations (1)
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1
Q-Pharm Pty Ltd (AKA Nucleus Network Brisbane)
Herston, Queensland, Australia, 4006