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

Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study ID
NCT07036172
Phase
PHASE3
Status
Recruiting
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Conditions

  • Obesity Control

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 3, 2025
Status verified
Jun 2025
Primary completion
Apr 30, 2026
Completion
May 31, 2026

Study Design

Enrollment
460 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HDM1702
  • Active Comparator: WEGOVY®

Primary Outcome Measure

The percentage change in body weight from baseline to week 44 [ Time Frame: week 44 ]

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