A Study of HS-20094 in Patients With T2DM

What Was Tested

The trial (phase 2) is built around Dulaglutide.

This is a 32-week, phase 2, randomized study, HS-20094 and placebo were double-blind, dulaglutide was open-label.

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.

It had five arms (groups): one (experimental), one (experimental), one (experimental), one (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 275 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female patients 18 to 75 years of age, inclusive. Patients were diagnosed with T2DM for at least 3 months before screening. Body mass index (BMI）≥ 22 kg/m2.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: type 1 diabetes, gestational diabetes, monogenic diabetes, secondary diabetes, or undetermined diabetes as assessed by the investigator; acute or chronic pancreatitis at any time before screening, or serum lipase/amylase above the upper limit of normal at screening; occurrence of diabetic ketoacidosis, hyperosmolar coma, or lactic acidosis two or more times within 6 months prior to screening.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Dulaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Dulaglutide.

Those kept unaware of assignments: participant and investigator.

It started in 2024-02-06 with completion listed for 2025-03-07.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The change of HbA1c in the patients (time frame: From baseline to week 32).

It also tracked 7 secondary outcomes, for example The change in fasting blood glucose, The change in C peptide, The change of fasting insulin in the patients and The change in body weight.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Dulaglutide in 275 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Dulaglutide compound page, all human trials.