A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study Comparing the Efficacy and Safety of Semaglutide Injection and WEGOVY® in Chinese Obese Patients

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Male or female, aged ≥18 years and ≤75 years at the time of signing informed consent;

• BMI ≥28 kg/m2;

• A self-reported change in body weight no more than 5% within 90 days before screening.

Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Time Frame
Start Date: 2025-01-03
Estimated Completion Date: 2026-05
Participants
Target number of participants: 460
Treatments
Experimental: HDM1702
Active_comparator: WEGOVY®
Related Therapeutic Areas
Sponsors
Leads: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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