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ObesityPhase 2NCT05111912

Effects of XW003 Versus Liraglutide on Body Weight of Adult Participants With Obesity

A Phase 2 study testing XW003 and Saxenda in people with Obesity, run by Sciwind Biosciences APAC CO Pty. Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Obesity
What is being tested?
XW003 and Saxenda
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
1 siteAustralia
Study dates
30 Nov 2021to 20 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be eligible for this study, a participant has to meet all of the following inclusion criteria:
  • Male or female, aged 18 to 70 years (inclusive at the time of informed consent);
  • Participants must have a BMI ≥ 30.0 kg/m2 and ≤40.0 kg/m2 at Screening;
  • Participants must have a stable body weight for at least 3 months prior to Screening (<5% change, self-reported);
  • Participants must have glycated haemoglobin (HbA1c) level <6.5% at Screening;
  • 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.
  • Participants must have the ability and willingness to attend the necessary visits to the clinical research unit (CRU);
  • 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.

Who cannot join

  • A participant who meets any of the following exclusion criteria must be excluded from the study:
  • Diagnosis of type 2 (HbA1c ≥6.5%) or other types of diabetes mellitus;
  • Obesity induced by endocrine disorders (e.g., Cushing syndrome);
  • Calcitonin ≥50 ng/L (pg/mL) at Screening;
  • History of severe allergic or hypersensitivity to any of the investigational products or its excipients or to drugs of similar chemical classes;
  • History of cerebral stroke (including but not limited to cerebral infarction/haemorrhage) within 6 months prior to Screening;
Show all 41Show fewer
  • 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;
  • 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:
  • Male or female, aged 18 to 70 years (inclusive at the time of informed consent);
  • Participants must have a BMI ≥ 30.0 kg/m2 and ≤40.0 kg/m2 at Screening;
  • Participants must have stable body weight for at least 3 months prior to Screening (<5% change, self-reported);
  • Participants must have glycated hemoglobin (HbA1c) level <6.5% at Screening;
  • 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.
  • Participants must have the ability and willingness to attend the necessary visits to the clinical research unit (CRU);
  • 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 Exclusion Criteria:
  • A participant who meets any of the following exclusion criteria must be excluded from the study:
  • Diagnosis of type 2 (HbA1c ≥6.5%) or other types of diabetes mellitus;
  • Obesity induced by endocrine disorders (e.g., Cushing syndrome);
  • Calcitonin ≥50 ng/L (pg/mL) at Screening;
  • History of severe allergic or hypersensitivity to any of the investigational products or its excipients or to drugs of similar chemical classes;
  • History of cerebral stroke (including but not limited to cerebral infarction/haemorrhage) within 6 months prior to Screening;
  • 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;
  • Impaired liver function defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times upper limit of normal (ULN) at Screening;
  • Estimated glomerular filtration rate (eGFR), calculated using the modified diet in renal disease (MDRD) formula < 60 mL/min/1.73m2;
  • History of acute or chronic pancreatitis or defined as amylase >ULN at Screening;
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2);
  • Positive infection with human immunodeficient virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV);
  • History of primary or recurrent malignancy, except for non-melanoma skin cancer excised more than 2 years prior to Screening;
  • History of clinically significant endocrine condition(s);
  • History of major depressive disorder within 2 years before randomisation;
  • History of surgical treatment for obesity;
  • Having been exposed to any GLP-1 analogues within 6 months before Screening;
  • 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;
  • Use of any other investigational products or medical devices within 3 months prior to Screening;
  • 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);
  • Known or suspected abuse of alcohol or recreational drugs;
  • 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;
  • 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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Paratus Clinical Research Brisbane

    Brisbane, Queensland, 4010

Other trials in Australia

About this study

Official 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

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.

Read the detailed description

The study treatment period for 4 groups in the study will be divided into the four Titration Treatment periods and one Core Treatment period. The overall duration of the study treatment for each group will be 26 weeks. The duration of Titration Treatment will be up to 14 weeks for the three groups of XW003 treatment but 4 weeks for Saxenda group.

Approximately 250 participants who are adults with obesity, in the absence of type 2 or any other type of diabetes, are planned to be screened. Based on a 20% screening failure rate, a total of 200 participants are expected to be enrolled for the four groups.

Conditions
Obesity
Being tested
XW003, Saxenda
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XW003Drug

    Also called GLP-1 analogue

    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.

  • SaxendaDrug

    Also called GLP-1 analogue

    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).

Study groups in NCT05111912
Study groupRoleWhat they receive
Cohort AExperimentalParticipants 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.
Receives: Drug: XW003
Cohort BExperimentalParticipants 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.
Receives: Drug: XW003
Cohort CExperimentalParticipants 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.
Receives: Drug: XW003
Cohort DActive comparatorDose 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.
Receives: Drug: Saxenda

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change in participants body weight (%) from the Baseline

    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.

    Measured: Week 26

Secondary outcomes (18)

  1. Proportions of participants with body weight loss ≥5%, ≥10% and ≥15% of the Baseline

    It is anticipated that XW003 can achieve considerable body weight loss and improve obesity-related markers in participants with obesity.

    Measured: Week 26

  2. Absolute change in body weight (kg) of participants

    Body weight should be measured at all site visits without shoes, on an empty bladder and only wearing light clothing.

    Measured: Week 26

  3. Changes in waist circumference and hip circumference (cm) in participants

    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.

    Measured: Week 26

  4. Change in BMI in participants

    Calculated by dividing the participant's body weight in kilograms by the participant's height in meters squared (kg/m2)

    Measured: Week 26

  5. Change in fasting plasma glucose (FPG)

    Calculated based on XW003 measured in blood.

    Measured: Week 26

  6. Change in fasting serum insulin

    Calculated based on XW003 measured in blood.

    Measured: Week 26

  7. Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    Measured: Week 26

  8. Changes in fasting lipids (triglyceride, low-density lipoprotein [LDL], and high-density lipoprotein [HDL])

    Lipids: triglyceride, low-density lipoprotein [LDL], and high-density lipoprotein [HDL].

    Measured: Week 26

  9. Number and severity of treatment-emergent adverse events (TEAEs)

    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.

    Measured: Week 26

  10. Number and severity of new and ongoing gastrointestinal (GI) disorder (nausea, vomiting, diarrhea, and constipation) events by week

    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.

    Measured: Week 26

  11. Vital signs - participants' blood pressure change

    After resting in a supine position for at least 5 minutes, the participant's systolic and diastolic blood pressure change.

    Measured: Week 26

  12. Vital signs - participants' pulse rate change

    After resting in a supine position for at least 5 minutes, the participant's pulse rate, and body temperature.

    Measured: Week 26

  13. Vital signs - participants' ody temperature change

    After resting in a supine position for at least 5 minutes, the participant's body temperature change.

    Measured: Week 26

  14. Electrocardiograms (ECGs)

    There was no XW003 injection related clinically significant effect 12-lead electrocardiography (ECG).

    Measured: Week 26

  15. Haematology, biochemistry, coagulation, and calcitonin

    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)

    Measured: Week 26

  16. Injection site reactions (ISRs)

    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.

    Measured: Week 26

  17. Physical examinations

    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.

    Measured: Week 26

  18. 36-Item Short Form Survey (SF-36)

    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

    Measured: Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2021
  2. Study start30 Nov 2021
  3. Primary completion16 Nov 2022
  4. Study completion20 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05111912
Sponsor's protocol ID
SCW0502-1121
Status last verified
Aug 2023
First submitted
17 Oct 2021
Last updated
21 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing XW003 and Saxenda in people with Obesity, run by Sciwind Biosciences APAC CO Pty. Ltd. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change in participants body weight (%) from the Baseline (time frame: Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05111912.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.

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