A Study of HRS9531 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabetes

Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Study ID
NCT06649344
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • HRS9531 Injection — DRUG
    HRS9531 injected subcutaneously once weekly.
  • Semaglutide Injection — DRUG
    Semaglutide injected subcutaneously once weekly.

Study Details

The study is being conducted to evaluate the efficacy and safety of HRS9531 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Semaglutide QW for 36 weeks and 52 weeks.

Key Dates

Start date
Oct 31, 2024
Status verified
Jun 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

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

Arms

  • Experimental: Treatment group A
    HRS953-low dose
  • Experimental: Treatment group B
    HRS9531-high dose
  • Active Comparator: Treatment group C
    Semaglutide-1mg

Primary Outcome Measure

Change in HbA1c [ Time Frame: Week 0 to Week 36 ]

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