A Phase 3 Study of HS-20094 in Patients With T2DM

Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study ID
NCT07156539
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • HS-20094 Injection — DRUG
    HS-20094 injected subcutaneously once weekly
  • Dulaglutide Injection — DRUG
    Dulaglutide injected subcutaneously once weekly

Study Details

The study is being conducted to evaluate the efficacy and safety of HS-20094 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Dulaglutide QW for 44 weeks and 52 weeks.

Key Dates

Start date
Sep 30, 2025
Status verified
Aug 2025
Primary completion
Mar 30, 2027
Completion
May 30, 2027

Study Design

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

Arms

  • Experimental: Treatment Group A
    HS-20094-low dose
  • Experimental: Treatment Group B
    HS-20094-high dose
  • Active Comparator: Treatment Group C
    Dulaglutide -1.5mg

Primary Outcome Measure

Change in HbA1c [ Time Frame: Week 0 to Week 44 ]

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