NCT07156500

A Phase 3 Study of HS-20094 in Patients With T2DM Inadequately Controlled With Diet and Exercise Alone

A Multicenter, Randomized, Double-Blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HS-20094 Injection in Subjects With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Type 2 Diabetes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-09-30
• Primary completion: 2027-03-30
• Completion: 2027-05-30
• First posted: 2025-09-05
• Last updated: 2025-09-05

Locations

1 site across 1 country: China