NCT06118008

A Study of HS-20094 in T2DM Participants

A Multiple-dose, Randomized, Double-blind, Placebo and Positive Controlled Phase IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-20094 in Subjects With Type 2 Diabetes.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, placebo and active-control, multiple-dose, phase IIa trial. Patients were randomly assigned to receive HS-20094 (12 patients), placebo (3 patients), or active control drug Semaglutide injection (3 patients) in a 4:1:1 ratio to each of four dose cohorts of 5 mg, 10 mg, 15 mg, and 20 mg. HS-20094 and placebo were administered in a double-blind design by subcutaneous injection once a week for a total of four times, and the dose was gradually increased weekly (2.5-2.5-5-5 mg, 5-510-10 mg, 5-10-15-15 mg, 5-10-15-20 mg). The active control drug semaglutide was administered by open-label, titrated subcutaneous injection once a week for a total of four times, and the dose was increased gradually every week until 1.0 mg (0.25-0.5-0.5-1.0 mg). The primary study objective was to 1) Evaluate the safety and tolerability of multiple subcutaneous injections of HS-20094 in subjects with type 2 diabetes mellitus (T2DM) with or without overweight or obesity;2) Evaluate the pharmacokinetics, pharmacodynamics and immunogenicity of multiple subcutaneous injections of HS-20094.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	HS-20094 5mg	Administrated by subcutaneous injection
DRUG	HS-20094 10mg	Administrated by subcutaneous injection
DRUG	HS-20094 15mg	Administrated by subcutaneous injection
DRUG	HS-20094 20mg	Administrated by subcutaneous injection

Timeline

• Start date: 2023-05-31
• Primary completion: 2024-01-04
• Completion: 2024-01-04
• First posted: 2023-11-07
• Last updated: 2025-08-03

Locations

1 site across 1 country: China