NCT06901648

A Study of HS-20094 in Patients With T2DM

Efficacy and Safety of HS-20094, a Novel Dual GIP and GLP-1 Receptor Agonist, in Patients With Type 2 Diabetes: a Randomized, Placebo-controlled and Active Comparator-controlled Phase 2 Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a 32-week, phase 2, randomized study, HS-20094 and placebo were double-blind, dulaglutide was open-label. Adults with T2D inadequately controlled with diet and exercise alone or with stable metformin, an HbA1c (glycated hemoglobin) ≥53 to ≤91 mmol/mol (≥7.0 % to≤10.5 %) were randomly assigned to receive 5 mg HS-20094, 10 mg HS-20094, 15 mg HS-20094, placebo, or 1.5 mg dulaglutide subcutaneously for 32 weeks. The primary endpoint was change in HbA1C from baseline to 32 weeks, and secondary endpoints included change in fasting glucose, body weight and several additional measures relevant for cardiovascular risks.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	HS-20094	Administrated by subcutaneous injection once a week
DRUG	Dulaglutide	Administrated by subcutaneous injection once a week
DRUG	Palcebo	Administrated by subcutaneous injection once a week

Timeline

• Start date: 2024-02-06
• Primary completion: 2025-03-07
• Completion: 2025-04-09
• First posted: 2025-03-30
• Last updated: 2025-08-01

Locations

1 site across 1 country: China