A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity

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Primary Purpose

Status

Active

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Ecnoglutide Low Dosage

Ecnoglutide Medium Dosage

Ecnoglutide High Dosage

Placebo

About this trial

This is an interventional treatment trial for Weight Management focused on measuring Weight management, overweight, obesity, glucagon-like peptide-1 (GLP-1), ecnoglutide, XW003

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female, 18-75 years old, inclusive; BMI between 24.0 to 28.0 kg/m2 with at least one comorbidity, including prediabetes, hypertension, hyperlipidemia, fatty liver , obstructive sleep apnea syndrome, etc.; or BMI ≥ 28 kg/m2 with or without comorbidities. Weight change of no more than 5% (based on self-report), with diet and exercise alone, within 3 months before screening. Willing and able to maintain stable diet and exercise during the study period. Exclusion Criteria: Obesity induced by endocrine diseases such as hypothyroidism, Cushing Syndrome, etc. History of bariatric surgery (except liposuction >1 year ago) or planned bariatric surgery during the study period. Within 3 months before screening, history of using the following drugs or treatments: Any approved or unapproved weight-loss drugs or Chinese herbs or health products that affect body weight. Any hypoglycemic medication. Any medication that may cause significant weight gain, including systemic glucocorticoid treatment, tricyclic anti-depressants, anti-epileptic and antipsychotics. Any investigational drug, vaccine, or medical device.

Sites / Locations

Peking University People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

C1- XW003 Low Dosage

C1-Placebo

C2- XW003 Medium Dosage

C2-Placebo

C3- XW003 High Dosage

C3-Placebo

Arm Description

XW003 with low dosage once weekly

Matched Placebo once weekly

XW003 with medium dosage once weekly

Matched Placebo once weekly

XW003 with high dosage once weekly

Matched Placebo once weekly

Outcomes

Primary Outcome Measures

Percent change in body weight from baseline

Proportion of subjects with weight loss ≥5% from baseline

Secondary Outcome Measures

Percent and absolute body weight change from baseline

Proportion of subjects with weight loss ≥ 5%, 10%, 15% from baseline

Change from baseline in BMI

height will be only measured at baseline

Change from baseline in waist and hip circumferences

Full Information

NCT ID

NCT05813795

First Posted

March 20, 2023

Last Updated

July 13, 2023

Sponsor

Hangzhou Sciwind Biosciences Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05813795

Brief Title

A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity

Official Title

A Phase 3, Multi-center, Randomized, Double-Blind and Placebo-controlled Study to Evaluate the Efficacy and Safety of XW003 in Adults With Overweight or Obesity (SLIMMER)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 5, 2023 (Actual)

Primary Completion Date

January 22, 2025 (Anticipated)

Study Completion Date

January 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hangzhou Sciwind Biosciences Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

The aim of the study is to evaluate the efficacy and safety of XW003 versus placebo in adults with overweight or obesity

Detailed Description

In this Phase 3 study, eligible participants will be randomized into three cohorts in a 3:1:3:1:3:1 ratio to receive once-weekly subcutaneous XW003 (low, medium, or high dosage) or volume-matching placebo for 48 weeks, including a dose-escalation period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Management

Keywords

Weight management, overweight, obesity, glucagon-like peptide-1 (GLP-1), ecnoglutide, XW003

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

664 (Actual)

8. Arms, Groups, and Interventions

Arm Title

C1- XW003 Low Dosage

Arm Type

Experimental

Arm Description

XW003 with low dosage once weekly

Arm Title

C1-Placebo

Arm Type

Placebo Comparator

Arm Description

Matched Placebo once weekly

Arm Title

C2- XW003 Medium Dosage

Arm Type

Experimental

Arm Description

XW003 with medium dosage once weekly

Arm Title

C2-Placebo

Arm Type

Placebo Comparator

Arm Description

Matched Placebo once weekly

Arm Title

C3- XW003 High Dosage

Arm Type

Experimental

Arm Description

XW003 with high dosage once weekly

Arm Title

C3-Placebo

Arm Type

Placebo Comparator

Arm Description

Matched Placebo once weekly

Intervention Type

Drug

Intervention Name(s)

Ecnoglutide Low Dosage

Other Intervention Name(s)

XW003

Intervention Description

Subcutaneous Injection

Intervention Type

Drug

Intervention Name(s)

Ecnoglutide Medium Dosage

Other Intervention Name(s)

XW003

Intervention Description

Subcutaneous Injection

Intervention Type

Drug

Intervention Name(s)

Ecnoglutide High Dosage

Other Intervention Name(s)

XW003

Intervention Description

Subcutaneous Injection

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subcutaneous Injection with matched volume

Primary Outcome Measure Information:

Title

Percent change in body weight from baseline

Time Frame

Week 40

Title

Proportion of subjects with weight loss ≥5% from baseline

Time Frame

Week 40

Secondary Outcome Measure Information:

Title

Percent and absolute body weight change from baseline

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48

Title

Proportion of subjects with weight loss ≥ 5%, 10%, 15% from baseline

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48

Title

Change from baseline in BMI

Description

height will be only measured at baseline

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48

Title

Change from baseline in waist and hip circumferences

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Male or female, 18-75 years old, inclusive; BMI between 24.0 to 28.0 kg/m2 with at least one comorbidity, including prediabetes, hypertension, hyperlipidemia, fatty liver , obstructive sleep apnea syndrome, etc.; or BMI ≥ 28 kg/m2 with or without comorbidities. Weight change of no more than 5% (based on self-report), with diet and exercise alone, within 3 months before screening. Willing and able to maintain stable diet and exercise during the study period. Exclusion Criteria: Obesity induced by endocrine diseases such as hypothyroidism, Cushing Syndrome, etc. History of bariatric surgery (except liposuction >1 year ago) or planned bariatric surgery during the study period. Within 3 months before screening, history of using the following drugs or treatments: Any approved or unapproved weight-loss drugs or Chinese herbs or health products that affect body weight. Any hypoglycemic medication. Any medication that may cause significant weight gain, including systemic glucocorticoid treatment, tricyclic anti-depressants, anti-epileptic and antipsychotics. Any investigational drug, vaccine, or medical device.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linong Ji, Dr

Organizational Affiliation

Peking University People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University People's Hospital

City

Beijing

State/Province

Beijing

Country

China

12. IPD Sharing Statement

Plan to Share IPD

No

Weight Management

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial