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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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SCW0502-1121
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
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Condition category
Condition code
Diet and Nutrition
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Obesity
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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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).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage change in participants body weight (%) from the Baseline
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Assessment method [1]
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Analysis of covariance (ANCOVA), with treatment, baseline body weight, and stratification factor as covariate, will be used to determine the difference between one of the XW003 groups and Saxenda group.
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Timepoint [1]
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Week 26
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Secondary outcome [1]
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Proportions of participants with body weight loss =5%, =10% and =15% of the Baseline
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Assessment method [1]
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It is anticipated that XW003 can achieve considerable body weight loss and improve obesity-related markers in participants with obesity.
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Timepoint [1]
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Week 26
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Secondary outcome [2]
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Absolute change in body weight (kg) of participants
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Assessment method [2]
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Body weight should be measured at all site visits without shoes, on an empty bladder and only wearing light clothing.
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Timepoint [2]
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Week 26
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Secondary outcome [3]
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Changes in waist circumference and hip circumference (cm) in participants
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Assessment method [3]
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The waist circumference will be measured at the specified visits and is defined as the abdominal circumference located the midpoint between the lower rib margin and the iliac crest. The hip circumference is defined as the widest circumference around the buttocks.
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Timepoint [3]
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Week 26
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Secondary outcome [4]
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Change in BMI in participants
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Assessment method [4]
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Calculated by dividing the participant's body weight in kilograms by the participant's height in meters squared (kg/m2)
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Timepoint [4]
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Week 26
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Secondary outcome [5]
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Change in fasting plasma glucose (FPG)
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Assessment method [5]
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Calculated based on XW003 measured in blood.
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Timepoint [5]
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Week 26
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Secondary outcome [6]
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Change in fasting serum insulin
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Assessment method [6]
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Calculated based on XW003 measured in blood.
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Timepoint [6]
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Week 26
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Secondary outcome [7]
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Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
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Assessment method [7]
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Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
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Timepoint [7]
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Week 26
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Secondary outcome [8]
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Changes in fasting lipids (triglyceride, low-density lipoprotein [LDL], and high-density lipoprotein [HDL])
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Assessment method [8]
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Lipids: triglyceride, low-density lipoprotein [LDL], and high-density lipoprotein [HDL].
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Timepoint [8]
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Week 26
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Secondary outcome [9]
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Number and severity of treatment-emergent adverse events (TEAEs)
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Assessment method [9]
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The most common treatment-emergent adverse events (TEAEs) were nausea, dyspepsia, constipation, vomiting, and loss of appetite, all of which deemed possibly related to XW003 injection and only occurred in the highest dose groups (0.6 mg and 1.0 mg). The severity of these TEAEs was mild or moderate.
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Timepoint [9]
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Week 26
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Secondary outcome [10]
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Number and severity of new and ongoing gastrointestinal (GI) disorder (nausea, vomiting, diarrhea, and constipation) events by week
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Assessment method [10]
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Analysis of the safety profile and tolerability of XW003 showed that the most common adverse events (AEs) of XW003 was gastrointestinal (GI) disorder, including nausea, bloating, loss of appetite, and weight loss.
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Timepoint [10]
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Week 26
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Secondary outcome [11]
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Vital signs - participants' blood pressure change
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Assessment method [11]
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After resting in a supine position for at least 5 minutes, the participant's systolic and diastolic blood pressure change.
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Timepoint [11]
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Week 26
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Secondary outcome [12]
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Vital signs - participants' pulse rate change
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Assessment method [12]
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After resting in a supine position for at least 5 minutes, the participant's pulse rate, and body temperature.
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Timepoint [12]
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Week 26
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Secondary outcome [13]
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Vital signs - participants' ody temperature change
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Assessment method [13]
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After resting in a supine position for at least 5 minutes, the participant's body temperature change.
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Timepoint [13]
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Week 26
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Secondary outcome [14]
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Electrocardiograms (ECGs)
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Assessment method [14]
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There was no XW003 injection related clinically significant effect 12-lead electrocardiography (ECG).
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Timepoint [14]
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Week 26
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Secondary outcome [15]
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Haematology, biochemistry, coagulation, and calcitonin
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Assessment method [15]
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Parameters to be tested are:
Haemoglobin (HGB)
Haematocrit (HCT)
Erythrocytes (RBC)
Platelets (PLAT)
Leucocytes (WBC) with differential
Urea
Creatinine (CREAT)
Total Bilirubin (BILI) and direct bilirubin (BILIDIR)
Urate
Albumin (ALB)
Alkaline phosphatase (ALP)
Creatine kinase (CK)
Alanine aminotransferase (ALT)
Aspartate aminotransferase (AST)
Gamma-glutamyl transferase (GGT)
Sodium (NA)
Potassium (K)
Calcium (CA)
Chloride (CL)
Phosphate (PHOS)
Bicarbonate (BICARB)
Amylase
Lipase
International Normalised Ratio (INR)
Activated partial thromboplastin time (APTT)
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Timepoint [15]
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Week 26
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Secondary outcome [16]
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Injection site reactions (ISRs)
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Assessment method [16]
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There were no hypoglycaemic episodes reported during the trial. Injection site reaction (ISRs) were reported in 1 participant in Cohort A2 (0.2/0.25 mg) and 2 participants in Cohort A6 (0.6 mg).
The ISRs were mild in severity and recovered within 3 hours of dosing.
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Timepoint [16]
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Week 26
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Secondary outcome [17]
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Physical examinations
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Assessment method [17]
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It should include general appearance, thyroid gland, respiratory system, cardiovascular system, gastrointestinal system including mouth, musculoskeletal system, central and peripheral nervous system, skin, lymph node palpation, and head, ears, eyes, nose, throat and neck.
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Timepoint [17]
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Week 26
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Secondary outcome [18]
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36-Item Short Form Survey (SF-36)
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Assessment method [18]
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Physical and mental component summary scores and scores on the individual sub-domains, i.e., physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health
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Timepoint [18]
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Week 26
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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.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/11/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/12/2022
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Sample size
Target
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Accrual to date
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Final
206
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Paratus Clinical Research Brisbane - Brisbane
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Recruitment postcode(s) [1]
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4010 - Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sciwind Biosciences APAC CO Pty. Ltd.
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Hangzhou Sciwind Biosciences Co., Ltd.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05111912
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sheetal Bull
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Address
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Paratus Clinical
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05111912
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