Semaglutide in Treatment of Obesity

Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Study ID
NCT06604624
Phase
PHASE3
Status
Completed

Conditions

  • Weight Management

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HD1916 — DRUG
    HD1916，0.25mg/0.5mg/1.0mg/1.7mg/2.4mg，SC，once a week
  • semaglutide — DRUG
    semaglutide ，0.25mg/0.5mg/1.0mg/1.7mg/2.4mg，SC，once a week

Study Details

This is a multicenter, randomized, open, positive parallel controlled phase III clinical trial to compare the efficacy and safety of once-weekly HD1916 and semaglutide injection and to evaluate immunogenicity in obese non-diabetic adults.

Key Dates

Start date
Sep 20, 2024
Status verified
Jul 2024
Primary completion
Aug 27, 2025
Completion
Sep 24, 2025

Study Design

Enrollment
462 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HD1916
    HD1916 will be administered via subcutaneous injection once a week in subjects with obesity.
  • Active Comparator: semaglutide
    semaglutide will be administered via subcutaneous injection once a week in subjects with obesity.

Primary Outcome Measure

Relative percentage change in body weight from baseline at 44 weeks of treatment [ Time Frame: Baseline through Week44 ]

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