A Study of HS-20094 in T2DM Participants

NCT06118008 · Completed

Last updated 2026-05-28

This clinical trial is testing the safety of the experimental drug HS-20094 in adults with type 2 diabetes by monitoring side effects and their severity.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 54 people

Who can join Ages 20–65 · all sexes

Timeline Started 2023-05 · est. completion 2024-01

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT06118008 ↗

Description as written by the study sponsor.

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.

Treatments tested

HS-20094 5mg also known as HS-20094 injection 5mg Drug

Administrated by subcutaneous injection
HS-20094 10mg also known as HS-20094 injection 10mg Drug

Administrated by subcutaneous injection
HS-20094 15mg also known as HS-20094 injection 15mg Drug

Administrated by subcutaneous injection
HS-20094 20mg also known as HS-20094 injection 20mg Drug

Administrated by subcutaneous injection

Main thing measured	Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug
Sponsor	Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions studied	Type 2 Diabetes
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06118008 ↗