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

Weight Management Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05813795
• Other study ID #: SCW0502-1131
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 5, 2023
• Est. completion date: January 22, 2025

Study information

• Verified date: July 2023
• Source: Hangzhou Sciwind Biosciences Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 664
• Est. completion date: January 22, 2025
• Est. primary completion date: January 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Management

Intervention

Drug:
• Ecnoglutide Low Dosage
Subcutaneous Injection
• Ecnoglutide Medium Dosage
Subcutaneous Injection
• Ecnoglutide High Dosage
Subcutaneous Injection
• Placebo
Subcutaneous Injection with matched volume

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Sciwind Biosciences Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in body weight from baseline		Week 40
Primary	Proportion of subjects with weight loss =5% from baseline		Week 40
Secondary	Percent and absolute body weight change from baseline		Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
Secondary	Proportion of subjects with weight loss = 5%, 10%, 15% from baseline		Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
Secondary	Change from baseline in BMI	height will be only measured at baseline	Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
Secondary	Change from baseline in waist and hip circumferences		Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48