Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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
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
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
Secondary ID [1] 0 0
SCW0503-1011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of treatment emergent adverse events (TEAEs)
Timepoint [1] 0 0
36 days
Secondary outcome [1] 0 0
Maximum observed drug concentration
Timepoint [1] 0 0
36 days
Secondary outcome [2] 0 0
Time of the maximum drug concentration
Timepoint [2] 0 0
36 days
Secondary outcome [3] 0 0
Maximum plasma concentration after last dosing
Timepoint [3] 0 0
36 days
Secondary outcome [4] 0 0
Change from Baseline in body weight
Timepoint [4] 0 0
36 days
Secondary outcome [5] 0 0
Change from Baseline in fasting plasma glucose
Timepoint [5] 0 0
36 days
Secondary outcome [6] 0 0
Maximum observed drug concentration T2026
Timepoint [6] 0 0
36 days
Secondary outcome [7] 0 0
Time of the maximum drug concentration T2026
Timepoint [7] 0 0
36 days
Secondary outcome [8] 0 0
Maximum plasma concentration after last dosing T2026
Timepoint [8] 0 0
36 days
Secondary outcome [9] 0 0
Incidence of anti-XW004 antibodies at end of study
Timepoint [9] 0 0
36 days

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;
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/02/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2023
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sciwind Biosciences APAC CO Pty. Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Hangzhou Sciwind Biosciences Co., Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05184322
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard Friend
Address 0 0
Nucleus Network Brisbane Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
HONG QIN
Address 0 0
Country 0 0
Phone 0 0
(+86)13679290113
Fax 0 0
Email 0 0
hong.qin@sciwindbio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05184322