Clinical trial NCT05813795: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Weight Management
Keywords: Weight management
overweight
obesity
glucagon-like peptide-1 (GLP-1)
ecnoglutide
XW003
Lead sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-14
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Percent change in body weight from baseline
timeFrame: Week 40
measure: Proportion of subjects with weight loss ≥5% from baseline
timeFrame: Week 40
Secondary outcomes:
measure: Percent and absolute body weight change from baseline
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
measure: Proportion of subjects with weight loss ≥ 5%, 10%, 15% from baseline
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
measure: Change from baseline in BMI
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
measure: Change from baseline in waist and hip circumferences
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Linong Ji, Dr
role: PRINCIPAL_INVESTIGATOR
References: