Efficacy and Safety of Semaglutide Injection Vs WEGOVY® in Chinese Obese Patients
Recruiting
Phase 3
Interventional Study
Obesity Control
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 460 (estimated)
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
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About This Trial
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 …
Trial Locations
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Eligibility 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 pla…
Contacts
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