XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults
September 3, 2025 updated by: Sciwind Biosciences APAC CO Pty. Ltd.
A Phase 1, Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ecnoglutide Tablet in Healthy Adult Participants
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Queensland
-
Herston, Queensland, Australia, 4006
- Q-Pharm Pty Ltd (AKA Nucleus Network Brisbane)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Key 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 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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cohort 1A/1B
Cohort 1A/1B will enroll 14 healthy participants.
|
Once daily for 15 days.
Other Names:
Once daily for 15 days.
Once daily for 6 weeks.
Other Names:
Once daily and titrated up in concentration to once every week during maintenance period.
Other Names:
Once daily for 15 days.
Other Names:
Once daily for 6 weeks.
Other Names:
Once daily for 6 weeks.
Once daily to once weekly for 12 weeks.
Other Names:
Once daily to once weekly for 12 weeks.
|
|
Experimental: Cohort 2
Cohort 2 will enroll 14 healthy participants.
|
Once daily for 15 days.
Other Names:
Once daily for 15 days.
Once daily for 6 weeks.
Other Names:
Once daily and titrated up in concentration to once every week during maintenance period.
Other Names:
Once daily for 15 days.
Other Names:
Once daily for 6 weeks.
Other Names:
Once daily for 6 weeks.
Once daily to once weekly for 12 weeks.
Other Names:
Once daily to once weekly for 12 weeks.
|
|
Experimental: Cohort 3
Cohort 3 will enroll 14 healthy participants.
|
Once daily for 15 days.
Other Names:
Once daily for 15 days.
Once daily for 6 weeks.
Other Names:
Once daily and titrated up in concentration to once every week during maintenance period.
Other Names:
Once daily for 15 days.
Other Names:
Once daily for 6 weeks.
Other Names:
Once daily for 6 weeks.
Once daily to once weekly for 12 weeks.
Other Names:
Once daily to once weekly for 12 weeks.
|
|
Experimental: Cohort 4
Cohort 4 will enroll 14 otherwise healthy participants with obesity.
|
Once daily for 15 days.
Other Names:
Once daily for 15 days.
Once daily for 6 weeks.
Other Names:
Once daily and titrated up in concentration to once every week during maintenance period.
Other Names:
Once daily for 15 days.
Other Names:
Once daily for 6 weeks.
Other Names:
Once daily for 6 weeks.
Once daily to once weekly for 12 weeks.
Other Names:
Once daily to once weekly for 12 weeks.
|
|
Experimental: Cohort 5
Cohort 5 will enroll 14 otherwise healthy participants with obesity.
|
Once daily for 15 days.
Other Names:
Once daily for 15 days.
Once daily for 6 weeks.
Other Names:
Once daily and titrated up in concentration to once every week during maintenance period.
Other Names:
Once daily for 15 days.
Other Names:
Once daily for 6 weeks.
Other Names:
Once daily for 6 weeks.
Once daily to once weekly for 12 weeks.
Other Names:
Once daily to once weekly for 12 weeks.
|
|
Experimental: Cohort 6
Cohort 6 will enroll 14 otherwise healthy participants with obesity.
|
Once daily for 15 days.
Other Names:
Once daily for 6 weeks.
Other Names:
Once daily and titrated up in concentration to once every week during maintenance period.
Other Names:
Once daily for 15 days.
Other Names:
Once daily for 6 weeks.
Other Names:
Once daily to once weekly for 12 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number and percentage of treatment emergent adverse events (TEAEs) and serious adverse events (SAE)
Time Frame: Up to 98 days
|
Count of adverse events
|
Up to 98 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum observed drug concentration
Time Frame: 36 days
|
Calculated based on XW003 measured in blood.
|
36 days
|
|
Time of the maximum drug concentration
Time Frame: 36 days
|
Calculated based on XW003 measured in blood
|
36 days
|
|
Maximum plasma concentration after last dosing
Time Frame: 36 days
|
Calculated based on XW003 measured in blood
|
36 days
|
|
Change from Baseline in body weight
Time Frame: 36 days
|
Percentage of body weight loss
|
36 days
|
|
Change from Baseline in fasting plasma glucose
Time Frame: 36 days
|
Percentage of fasting plasma glucose change
|
36 days
|
|
Maximum observed drug concentration T2026
Time Frame: 36 days
|
Calculated based on T2026 measured in blood.
|
36 days
|
|
Time of the maximum drug concentration T2026
Time Frame: 36 days
|
Calculated based on T2026 measured in blood.
|
36 days
|
|
Maximum plasma concentration after last dosing T2026
Time Frame: 36 days
|
Calculated based on T2026 measured in blood.
|
36 days
|
|
Incidence of anti-XW004 antibodies at end of study
Time Frame: 36 days
|
Count of episodes
|
36 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Richard Friend, Nucleus Network Brisbane Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 12, 2022
Primary Completion (Actual)
July 13, 2024
Study Completion (Actual)
March 25, 2025
Study Registration Dates
First Submitted
December 21, 2021
First Submitted That Met QC Criteria
January 6, 2022
First Posted (Actual)
January 11, 2022
Study Record Updates
Last Update Posted (Estimated)
September 10, 2025
Last Update Submitted That Met QC Criteria
September 3, 2025
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Nutrition Disorders
- Metabolic Diseases
- Overnutrition
- Body Weight
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Overweight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Diabetes Mellitus, Type 2
- Substandard Drugs
- Pharmaceutical Preparations
- Counterfeit Drugs
Other Study ID Numbers
- SCW0503-1011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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