Efficacy and Safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Semaglutide.

This study is a randomized, open-label, active-controlled, parallel-group, multi-center Study.

It had two arms (groups): QLG1091 (experimental) and Rybelsus (active comparator).

The registry classes the interventions as drug.

Who Took Part

478 planned participants were the target.

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: Female or male，age 18 to 75. Body mass index (BMI) ≥ 22 kg/m² and ≤ 35 kg/m² at screening. Diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma; history of pancreatitis (acute or chronic); history of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Being open-label, the Semaglutide study did not mask who received what.

It started in 2026-05-01 with completion listed for 2026-12.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (time frame: Week 26).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 478 people.

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

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