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

NCT05111912 | Completed Phase 2 DMC

• 1 other identifier: SCW0502-1121
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (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.

  Week 26

Secondary Outcomes (18)

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

  Week 26

• Absolute change in body weight (kg) of participants

  Week 26

• Changes in waist circumference and hip circumference (cm) in participants

  Week 26

• Change in BMI in participants

  Week 26

• Change in fasting plasma glucose (FPG)

  Week 26

Other Outcomes (2)

• Plasma concentrations of XW003 on treatment

  Week 26

• Anti-XW003 antibodies on treatment

  Week 26

Study Arms (4)

Cohort A

EXPERIMENTAL

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.

Drug: XW003

Cohort B

EXPERIMENTAL

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.

Drug: XW003

Cohort C

EXPERIMENTAL

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.

Drug: XW003

Cohort D

ACTIVE COMPARATOR

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.

Drug: Saxenda

Interventions

XW003 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.

Also known as: GLP-1 analogue

Cohort A; Cohort B; Cohort C

Saxenda 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).

Also known as: GLP-1 analogue

Cohort D

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.
• Diagnosis of type 2 (HbA1c ≥6.5%) or other types of diabetes mellitus;

Sponsors & Collaborators

• Sciwind Biosciences APAC CO Pty. Ltd.: lead
• Hangzhou Sciwind Biosciences Co., Ltd.: collaborator

Study Sites (1)

Paratus Clinical Research Brisbane

Brisbane, Queensland, 4010, Australia

Location

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Sheetal Bull

  Paratus Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: November 8, 2021
• Study Start: November 30, 2021
• Primary Completion: November 16, 2022
• Study Completion: December 20, 2022
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)