Clinical trial

Efficacy and Safety of Semaglutide Injection Vs WEGOVY® in Chinese Obese Patients

Recruiting now · Phase 3 · 1 countries · Registry ID NCT07036172

Recruiting nowPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity Control

Full registry criteria

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;

Treatments and study arms

HDM1702

Drug

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.

Wegovy ®

Drug

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.

Primary outcomes

The percentage change in body weight from baseline to week 44week 44

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Peking University People's Hospital🇨🇳 Beijing, China
Linong Ji, Medical DoctorContact