Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05184322
Registration number
NCT05184322
Ethics application status
Date submitted
21/12/2021
Date registered
11/01/2022
Date last updated
11/01/2022
Titles & IDs
Public title
XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults
Query!
Scientific title
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
Query!
Secondary ID [1]
0
0
SCW0503-1011
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Obesity
0
0
Query!
Type 2 Diabetes Mellitus
0
0
Query!
Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - XW004
Treatment: Drugs - T2026
Treatment: Drugs - Placebo
Experimental: Cohort 1 - Cohort 1 will enroll 10 healthy participants, doses ranging from 2mg to 7mg.
Experimental: Cohort 2 - Cohort 2 will enroll 10 healthy participants, doses ranging from 2mg to 15mg.
Experimental: Cohort 3 - Cohort 3 will enroll 10 healthy participants, doses ranging from 7mg to 30mg.
Experimental: Cohort 4 - Cohort 4 will enroll 10 otherwise 'healthy' participants with obesity, doses ranging from 7mg to 30mg.
Experimental: T2026 tablet - Tablet containing no ecnoglutide but T2026 2 participants receiving T2026 tablet will be enrolled in each cohort.
Placebo Comparator: Placebo tablet - placebo containing no ecnoglutide or T2026 2 participants receiving placebo tablet will be enrolled in each cohort.
Treatment: Drugs: XW004
2, 7, 15, 30mg tablets once daily for 15 days.
Treatment: Drugs: T2026
Once daily for 15 days.
Treatment: Drugs: Placebo
Once daily for 15 days.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of treatment emergent adverse events (TEAEs)
Query!
Assessment method [1]
0
0
Count of adverse events
Query!
Timepoint [1]
0
0
36 days
Query!
Secondary outcome [1]
0
0
Maximum observed drug concentration
Query!
Assessment method [1]
0
0
Calculated based on XW003 measured in blood.
Query!
Timepoint [1]
0
0
36 days
Query!
Secondary outcome [2]
0
0
Time of the maximum drug concentration
Query!
Assessment method [2]
0
0
Calculated based on XW003 measured in blood
Query!
Timepoint [2]
0
0
36 days
Query!
Secondary outcome [3]
0
0
Maximum plasma concentration after last dosing
Query!
Assessment method [3]
0
0
Calculated based on XW003 measured in blood
Query!
Timepoint [3]
0
0
36 days
Query!
Secondary outcome [4]
0
0
Change from Baseline in body weight
Query!
Assessment method [4]
0
0
Percentage of body weight loss
Query!
Timepoint [4]
0
0
36 days
Query!
Secondary outcome [5]
0
0
Change from Baseline in fasting plasma glucose
Query!
Assessment method [5]
0
0
Percentage of fasting plasma glucose change
Query!
Timepoint [5]
0
0
36 days
Query!
Secondary outcome [6]
0
0
Maximum observed drug concentration T2026
Query!
Assessment method [6]
0
0
Calculated based on T2026 measured in blood.
Query!
Timepoint [6]
0
0
36 days
Query!
Secondary outcome [7]
0
0
Time of the maximum drug concentration T2026
Query!
Assessment method [7]
0
0
Calculated based on T2026 measured in blood.
Query!
Timepoint [7]
0
0
36 days
Query!
Secondary outcome [8]
0
0
Maximum plasma concentration after last dosing T2026
Query!
Assessment method [8]
0
0
Calculated based on T2026 measured in blood.
Query!
Timepoint [8]
0
0
36 days
Query!
Secondary outcome [9]
0
0
Incidence of anti-XW004 antibodies at end of study
Query!
Assessment method [9]
0
0
Count of episodes
Query!
Timepoint [9]
0
0
36 days
Query!
Eligibility
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;
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
55
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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;
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Unknown status
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
1/02/2022
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/02/2023
Query!
Actual
Query!
Sample size
Target
56
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Recruitment hospital [1]
0
0
Q-Pharm Pty Ltd - Brisbane
Query!
Recruitment postcode(s) [1]
0
0
4006 - Brisbane
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Sciwind Biosciences APAC CO Pty. Ltd.
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Hangzhou Sciwind Biosciences Co., Ltd.
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05184322
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Richard Friend
Query!
Address
0
0
Nucleus Network Brisbane Clinic
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
HONG QIN
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
(+86)13679290113
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05184322
Download to PDF