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

NCT ID: NCT05111912

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2022-12-20

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

XW003

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

XW003

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

XW003

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Saxenda

Intervention Type: DRUG

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).

Interventions

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.

Intervention Type: DRUG

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 Type: DRUG

Other Intervention Names

GLP-1 analogue; GLP-1 analogue

Eligibility Criteria

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.

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.

Exclusion Criteria

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;

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Sciwind Biosciences Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sciwind Biosciences APAC CO Pty. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheetal Bull

Role: PRINCIPAL_INVESTIGATOR

Paratus Clinical

Locations

Paratus Clinical Research Brisbane

Brisbane, Queensland, Australia

Countries

Australia

Other Identifiers

SCW0502-1121

Identifier Type: -

Identifier Source: org_study_id