A Phase 3 Study of HS-20094 in Patients With T2DM

What Was Tested

The trial (phase 3) is built around Dulaglutide.

It had three arms (groups): Treatment Group A (experimental), Treatment Group B (experimental) and Treatment Group C (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 546 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Males and females, Age ≥18 years at the time of signing informed consent. BMI ≥ 23 kg/m2.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmhg or diastolic blood pressure ≥100 mmhg at screening; diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes; severe infection, severe trauma, or moderate-to-major surgery within 4 weeks before screening.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

The Dulaglutide group and the comparison group ran side by side rather than switching.

Everyone knew when Dulaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-09-30 with completion listed for 2027-03-30.

It ran at 2 sites in China (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (time frame: Week 0 to Week 44).

It also tracked 10 secondary outcomes, for example Change in FPG, Change in body weight, Change in HbA1c, Change in FPG, Change in body weight and Incidence and severity of adverse events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Dulaglutide in 546 people.

With 546 participants it is a large trial for this field.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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