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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05111912




Registration number
NCT05111912
Ethics application status
Date submitted
17/10/2021
Date registered
8/11/2021
Date last updated
21/08/2023

Titles & IDs
Public title
Effects of XW003 Versus Liraglutide on Body Weight of Adult Participants With Obesity
Scientific title
A Phase 2, Open-label, Randomised, Dose-Finding Study of XW003, Once-Weekly Human Glucagon-Like Peptide 1 Analogue, Compared With Once-Daily Liraglutide 3 mg in Adult Participants With Obesity
Secondary ID [1] 0 0
SCW0502-1121
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - XW003
Treatment: Drugs - Saxenda

Experimental: Cohort A - Participants will follow a fixed up-titration scheme. For XW003 groups, the dose will be up-titrated to 1.2, 1.8, or 2.4 mg once weekly starting with 0.2 mg in dose increments of 0.2, 0.4, 0.6, or 0.8 mg. In order to mitigate the dose-related side effects, liraglutide is up-titrated over 4 weeks to the maintenance dose, 3.0 mg once daily.

Experimental: Cohort B - Participants will follow a fixed up-titration scheme. For XW003 groups, the dose will be up-titrated to 1.2, 1.8, or 2.4 mg once weekly starting with 0.2 mg in dose increments of 0.2, 0.4, 0.6, or 0.8 mg. In order to mitigate the dose-related side effects, liraglutide is up-titrated over 4 weeks to the maintenance dose, 3.0 mg once daily.

Experimental: Cohort C - Participants will follow a fixed up-titration scheme. For XW003 groups, the dose will be up-titrated to 1.2, 1.8, or 2.4 mg once weekly starting with 0.2 mg in dose increments of 0.2, 0.4, 0.6, or 0.8 mg. In order to mitigate the dose-related side effects, liraglutide is up-titrated over 4 weeks to the maintenance dose, 3.0 mg once daily.

Active comparator: Cohort D - Dose titration Saxenda (from 0.6 mg to 3.0 mg liraglutide once daily), should take place during the first 4 weeks after randomisation as described: Dose Escalation Schedule of Reference Product (Saxenda). All participants assigned to the open-labeled control group should aim to reach the final target dose of 3.0 mg liraglutide once daily.


Treatment: Drugs: XW003
XW003 (from 0.2 mg to 1.2 mg, 1.8 mg, and 2.4 mg once weekly), should take place during the first 14 weeks after randomization as described: Dose Escalation Schedule of Investigational Product (XW003). All eligible participants assigned to the XW003 study groups should aim to reach the respective final target dose of XW003 at 1.2 mg, 1.8 mg, or 2.4 mg once weekly.

Treatment: Drugs: Saxenda
If a participant does not tolerate the recommended target dose of Saxenda group (e.g., 3.0 mg once daily), the participant may stay at the preceding highest tolerable dose (e.g., 2.4 mg once daily).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage change in participants body weight (%) from the Baseline
Timepoint [1] 0 0
Week 26
Secondary outcome [1] 0 0
Proportions of participants with body weight loss =5%, =10% and =15% of the Baseline
Timepoint [1] 0 0
Week 26
Secondary outcome [2] 0 0
Absolute change in body weight (kg) of participants
Timepoint [2] 0 0
Week 26
Secondary outcome [3] 0 0
Changes in waist circumference and hip circumference (cm) in participants
Timepoint [3] 0 0
Week 26
Secondary outcome [4] 0 0
Change in BMI in participants
Timepoint [4] 0 0
Week 26
Secondary outcome [5] 0 0
Change in fasting plasma glucose (FPG)
Timepoint [5] 0 0
Week 26
Secondary outcome [6] 0 0
Change in fasting serum insulin
Timepoint [6] 0 0
Week 26
Secondary outcome [7] 0 0
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Timepoint [7] 0 0
Week 26
Secondary outcome [8] 0 0
Changes in fasting lipids (triglyceride, low-density lipoprotein [LDL], and high-density lipoprotein [HDL])
Timepoint [8] 0 0
Week 26
Secondary outcome [9] 0 0
Number and severity of treatment-emergent adverse events (TEAEs)
Timepoint [9] 0 0
Week 26
Secondary outcome [10] 0 0
Number and severity of new and ongoing gastrointestinal (GI) disorder (nausea, vomiting, diarrhea, and constipation) events by week
Timepoint [10] 0 0
Week 26
Secondary outcome [11] 0 0
Vital signs - participants' blood pressure change
Timepoint [11] 0 0
Week 26
Secondary outcome [12] 0 0
Vital signs - participants' pulse rate change
Timepoint [12] 0 0
Week 26
Secondary outcome [13] 0 0
Vital signs - participants' ody temperature change
Timepoint [13] 0 0
Week 26
Secondary outcome [14] 0 0
Electrocardiograms (ECGs)
Timepoint [14] 0 0
Week 26
Secondary outcome [15] 0 0
Haematology, biochemistry, coagulation, and calcitonin
Timepoint [15] 0 0
Week 26
Secondary outcome [16] 0 0
Injection site reactions (ISRs)
Timepoint [16] 0 0
Week 26
Secondary outcome [17] 0 0
Physical examinations
Timepoint [17] 0 0
Week 26
Secondary outcome [18] 0 0
36-Item Short Form Survey (SF-36)
Timepoint [18] 0 0
Week 26

Eligibility
Key inclusion criteria
To be eligible for this study, a participant has to meet all of the following inclusion criteria:

1. Male or female, aged 18 to 70 years (inclusive at the time of informed consent);
2. Participants must have a BMI = 30.0 kg/m2 and =40.0 kg/m2 at Screening;
3. Participants must have a stable body weight for at least 3 months prior to Screening (<5% change, self-reported);
4. Participants must have glycated haemoglobin (HbA1c) level <6.5% at Screening;
5. Women of childbearing potential (WOCBP) must be non-pregnant and must use an acceptable, highly effective contraception from Screening until the study completion, including the follow-up period.
6. Participants must have the ability and willingness to attend the necessary visits to the clinical research unit (CRU);
7. Participants must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A participant who meets any of the following exclusion criteria must be excluded from the study:

1. Diagnosis of type 2 (HbA1c =6.5%) or other types of diabetes mellitus;
2. Obesity induced by endocrine disorders (e.g., Cushing syndrome);
3. Calcitonin =50 ng/L (pg/mL) at Screening;
4. History of severe allergic or hypersensitivity to any of the investigational products or its excipients or to drugs of similar chemical classes;
5. History of cerebral stroke (including but not limited to cerebral infarction/haemorrhage) within 6 months prior to Screening;
6. History of acute coronary syndrome (angina pectoris and/or myocardial infarction) and any other major cardiac conditions (including but not limited to myocarditis, cardiac insufficiency/failure, and any clinically significant arrythmia[s]) within 6 months prior to Screening;
7. Impaired liver function defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times upper limit of normal (ULN) at Screening;

Main Inclusion Criteria:

To be eligible for this study, a participant has to meet all of the following inclusion criteria:

1. Male or female, aged 18 to 70 years (inclusive at the time of informed consent);
2. Participants must have a BMI = 30.0 kg/m2 and =40.0 kg/m2 at Screening;
3. Participants must have stable body weight for at least 3 months prior to Screening (<5% change, self-reported);
4. Participants must have glycated hemoglobin (HbA1c) level <6.5% at Screening;
5. Women of childbearing potential (WOCBP) must be non-pregnant and must use an acceptable, highly effective contraception from Screening until the study completion, including the follow-up period.
6. Participants must have the ability and willingness to attend the necessary visits to the clinical research unit (CRU);
7. Participants must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.

Main

A participant who meets any of the following exclusion criteria must be excluded from the study:

1. Diagnosis of type 2 (HbA1c =6.5%) or other types of diabetes mellitus;
2. Obesity induced by endocrine disorders (e.g., Cushing syndrome);
3. Calcitonin =50 ng/L (pg/mL) at Screening;
4. History of severe allergic or hypersensitivity to any of the investigational products or its excipients or to drugs of similar chemical classes;
5. History of cerebral stroke (including but not limited to cerebral infarction/haemorrhage) within 6 months prior to Screening;
6. History of acute coronary syndrome (angina pectoris and/or myocardial infarction) and any other major cardiac conditions (including but not limited to myocarditis, cardiac insufficiency/failure, and any clinically significant arrythmia[s]) within 6 months prior to Screening;
7. Impaired liver function defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times upper limit of normal (ULN) at Screening;
8. Estimated glomerular filtration rate (eGFR), calculated using the modified diet in renal disease (MDRD) formula < 60 mL/min/1.73m2;
9. History of acute or chronic pancreatitis or defined as amylase >ULN at Screening;
10. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2);
11. Positive infection with human immunodeficient virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV);
12. History of primary or recurrent malignancy, except for non-melanoma skin cancer excised more than 2 years prior to Screening;
13. History of clinically significant endocrine condition(s);
14. History of major depressive disorder within 2 years before randomisation;
15. History of surgical treatment for obesity;
16. Having been exposed to any GLP-1 analogues within 6 months before Screening;
17. Treatment with orlistat, zonisamide, topiramate, phentermine, lorcaserin, bupropion and naltrexone alone or in combination or any other medications that could promote weight loss within 90 days prior to Screening;
18. Use of any other investigational products or medical devices within 3 months prior to Screening;
19. Participation in any medical (e.g., assisted by a clinical dietician or nutritionist) or non-medical (e.g., by a gym coach) diet and/or exercise program within 3 months prior to Screening and for the duration of the study (including the follow-up period);
20. Known or suspected abuse of alcohol or recreational drugs;
21. Being pregnant or lactating at Screening or planning to become pregnant (self or female partner) at any time during the study and for at least 3 months after the last dose of study drug;
22. Presence of any underlying physical and/or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/12/2022
Sample size
Target
Accrual to date
Final
206
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Paratus Clinical Research Brisbane - Brisbane
Recruitment postcode(s) [1] 0 0
4010 - 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
XW003 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/study/NCT05111912
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sheetal Bull
Address 0 0
Paratus Clinical
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05111912