Obesity Control
Conditions
Brief summary
This is a 48-week randomized, open-label, parallel-controlled biosimilar comparison study comparing the efficacy, safety and immunogenicity of the investigational drug and WEGOVY® in patients with obesity. Eligible participants will be screened and randomized to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or WEGOVY® injection will be given once weekly for 44 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.
Interventions
DRUGHDM1702
Initiate at a once weekly dose of 0.25 mg and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg per week) aiming at reaching the maintenance dose of 2.4 mg at week 16.
DRUGWegovy ®
Initiate at a once weekly dose of 0.25 mg and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg per week) aiming at reaching the maintenance dose of 2.4 mg at week 16.
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Statistician, data manager and medical monitor are masked to the randomized allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, aged ≥18 years and ≤75 years at the time of signing informed consent； 2. BMI ≥28 kg/m2； 3. A self-reported change in body weight no more than 5% within 90 days before screening.
Exclusion criteria
1. History of type 1 and type 2 diabetes; 2. Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device; 3. History or presence of chronic or acute pancreatitis; 4. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma; 5. A history or presence of suspected depression or other mental disorders; 6. Patient Health Questionnaire-9 score of ≥15 at screening 7. Uncontrolled hypertension, any of the following: myocardial infarction, stroke, hospitalisation for unstable angina, or transient ischaemic attack within the past 6 months prior to screening; 8. History of malignant neoplasms within the past 5 years prior to screening;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage change in body weight from baseline to week 44 | week 44 |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of participants reaching a body weight loss of at least 5%, 10% and 15% at week 44 | week 44 |
| Change in waist circumference, body weight and BMI at week 44 | week 44 |
| Change in blood pressure and lipids at week 44 | week 44 |
| Adverse events | week 44 |
| ADA and NAb | week 44 |
Countries
China
Outcome results
None listed