UBT251 Injection Phase II (Type 2 Diabetes Mellitus) Study

What Was Tested

The trial (phase 2) is built around Semaglutide.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 211 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: Age 18-75 years (inclusive) at the time of informed consent; sex not restricted. Body weight: ≥50.0 kg for men and ≥45.0 kg for women at screening; body-mass index (BMI) 23.0-40.0 kg/m² (inclusive). Has been fully informed about the study and voluntarily signed the written informed consent form.

The full record lists 6 inclusion and 43 exclusion criteria; among the exclusions: prior use of any of the following medications:; systemic glucocorticoids, growth hormone, or any drug that may affect glucose metabolism within 3 months before screening; any weight-loss medication within 3 months before screening.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2025-03-22 with completion listed for 2025-11-21.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in HbA1c at Week 24 (time frame: Baseline to week 24).

It also tracked 12 secondary outcomes, for example Change Change from baseline to week 12, 16, 20 in HbA1c, Change in venous fasting plasma glucose (FPG) from baseline to week 12, 16, 20, 24, Change in 2-hour post-standard-meal plasma glucose from baseline to week 12, 24, Change in body weight from baseline to week 12, 24, Change in waist circumference from baseline to week 12, 24 and Combined target achievement rate for both HbA1c and FPG at Week 24.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 211 people.

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

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