A Phase 3 Study of HS-20094 in Patients With T2DM Inadequately Controlled With Diet and Exercise Alone
NCT07156500 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 204
Last updated 2025-09-05
Summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of HS-20094 injection in subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise alone. The primary objective of this study is to evaluate the effectiveness of HS-20094 compared to placebo in controlling blood glucose levels after 44 weeks and 52 weeks treatment.
Conditions
Interventions
- DRUG
-
HS-20094 Injection
HS-20094 injected subcutaneously once weekly
- DRUG
-
HS-20094 Placebo Injection
HS-20094 Placebo injected subcutaneously once weekly
- DRUG
-
HS-20094 Injection
HS-20094 injected subcutaneously once weekly
- DRUG
-
HS-20094 Placebo Injection
HS-20094 Placebo injected subcutaneously once weekly
Sponsors & Collaborators
-
Jiangsu Hansoh Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-30
- Primary Completion
- 2027-03-30
- Completion
- 2027-05-30
Countries
- China
Study Locations
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