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

• ClinicalTrials.gov Identifier: NCT05813795
• Recruitment Status: Active, not recruiting
• First Posted: April 14, 2023
• Last Update Posted: July 17, 2023
• Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
• Information provided by (Responsible Party): Hangzhou Sciwind Biosciences Co., Ltd.

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

Condition or disease	Intervention/treatment	Phase
Weight Management	Drug: Ecnoglutide Low Dosage; Drug: Ecnoglutide Medium Dosage; Drug: Ecnoglutide High Dosage; Drug: Placebo	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 664 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: April 5, 2023
• Estimated Primary Completion Date: January 22, 2025
• Estimated Study Completion Date: January 22, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: C1- XW003 Low Dosage; XW003 with low dosage once weekly	Drug: Ecnoglutide Low Dosage; Subcutaneous Injection; Other Name: XW003
Placebo Comparator: C1-Placebo; Matched Placebo once weekly	Drug: Placebo; Subcutaneous Injection with matched volume
Experimental: C2- XW003 Medium Dosage; XW003 with medium dosage once weekly	Drug: Ecnoglutide Medium Dosage; Subcutaneous Injection; Other Name: XW003
Placebo Comparator: C2-Placebo; Matched Placebo once weekly	Drug: Placebo; Subcutaneous Injection with matched volume
Experimental: C3- XW003 High Dosage; XW003 with high dosage once weekly	Drug: Ecnoglutide High Dosage; Subcutaneous Injection; Other Name: XW003
Placebo Comparator: C3-Placebo; Matched Placebo once weekly	Drug: Placebo; Subcutaneous Injection with matched volume

Outcome Measures

Primary Outcome Measures :

1. Percent change in body weight from baseline [ Time Frame: Week 40 ]
2. Proportion of subjects with weight loss ≥5% from baseline [ Time Frame: Week 40 ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. Change from baseline in BMI [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48 ]
   height will be only measured at baseline
4. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Male or female, 18-75 years old, inclusive;
2. 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.
3. Weight change of no more than 5% (based on self-report), with diet and exercise alone, within 3 months before screening.
4. Willing and able to maintain stable diet and exercise during the study period.

Exclusion Criteria:

1. Obesity induced by endocrine diseases such as hypothyroidism, Cushing Syndrome, etc.
2. History of bariatric surgery (except liposuction >1 year ago) or planned bariatric surgery during the study period.

3. Within 3 months before screening, history of using the following drugs or treatments:

   1. Any approved or unapproved weight-loss drugs or Chinese herbs or health products that affect body weight.
   2. Any hypoglycemic medication.
   3. Any medication that may cause significant weight gain, including systemic glucocorticoid treatment, tricyclic anti-depressants, anti-epileptic and antipsychotics.
   4. Any investigational drug, vaccine, or medical device.

Contacts and Locations

Locations

China, Beijing

Peking University People's Hospital

Beijing, Beijing, China

Sponsors and Collaborators

Hangzhou Sciwind Biosciences Co., Ltd.

Investigators

• Principal Investigator: Linong Ji, Dr; Peking University People's Hospital

More Information

• Responsible Party: Hangzhou Sciwind Biosciences Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05813795
• Other Study ID Numbers: SCW0502-1131
• First Posted: April 14, 2023
• Last Update Posted: July 17, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hangzhou Sciwind Biosciences Co., Ltd.:

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

Additional relevant MeSH terms:

Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight