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

A Multicenter, Randomized, Open-label, Parallel-group, Active-controlled Clinical Trial to Evaluate Efficacy and Safety of QLG1091 Versus Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07487103

Enrollment

478

Registered

2026-03-23

Start date

2026-05-01

Completion date

2027-05-01

Last updated

2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

This study is to evaluate the efficacy and safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes. The primary objective is to demonstrate equivalence of QLG1091 and Rybelsus. This study is a randomized, open-label, active-controlled, parallel-group, multi-center Study. The total duration of the study will be approximately 33 weeks including screening and follow-up.

Interventions

DRUGQLG1091

Oral administration once-daily.

DRUGRybelsus

Oral administration once-daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Female or male，age 18 to 75. 2. Body mass index (BMI) ≥ 22 kg/m² and ≤ 35 kg/m² at screening. 3. HbA1c of 7.0-10.5 %. 4. Diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening. 5. Stable daily dose of metformin (at least 1500 mg or maximum tolerated dose≥1000 mg/day) at least 90 days prior to the day of screening.

Exclusion criteria

1. Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma. 2. History of pancreatitis (acute or chronic). 3. 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). 4. Subjects presently classified as being in New York Heart Association Class IV. 5. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening. 6. Renal impairment defined as Estimated Glomerular Filtration Rate below 60 mL/min/1.73 m\\\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).

Design outcomes

Primary

Measure	Time frame	Description
Change in HbA1c	Week 26	Change from baseline in HbA1c was evaluated at Week 26

Contacts

CONTACTFangyi Wang, Bachelor

fangyi.wang@qilu-pharma.com+86-18266419923

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026