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

Sciwind Biosciences

Status and phase: Completed; Phase 3

Conditions: Weight Management

Treatments: Drug: Ecnoglutide Low Dosage; Drug: Placebo; Drug: Ecnoglutide High Dosage; Drug: Ecnoglutide Medium Dosage

Study type: Interventional

Funder types: Industry

Identifiers

NCT05813795

SCW0502-1131

Details and patient eligibility

About

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

Full 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.

Enrollment: 664 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

664 participants in 6 patient groups, including a placebo group

C1- XW003 Low Dosage

Experimental group

Description:

XW003 with low dosage once weekly

Treatment:

Drug: Ecnoglutide Low Dosage

C1-Placebo

Placebo Comparator group

Description:

Matched Placebo once weekly

Treatment:

Drug: Placebo

C2- XW003 Medium Dosage

Experimental group

Description:

XW003 with medium dosage once weekly

Treatment:

Drug: Ecnoglutide Medium Dosage

C2-Placebo

Placebo Comparator group

Description:

Matched Placebo once weekly

Treatment:

Drug: Placebo

C3- XW003 High Dosage

Experimental group

Description:

XW003 with high dosage once weekly

Treatment:

Drug: Ecnoglutide High Dosage

C3-Placebo

Placebo Comparator group

Description:

Matched Placebo once weekly

Treatment:

Drug: Placebo