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Delfa

← All trials/NCT07487103

Not yet recruitingPhase 3

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

Asset

Semaglutide

GLP-1 agonist

Listed sites

0

Recruiting sites

-

Estimated enrollment

478

Study population

Type 2 diabetes

Eligibility highlights

•BMI ≥22•HbA1c 7-10.5%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07487103
Org study IDQLG1091-301

Timeline

Milestones

Study first posted2026-03-23actual
Last update posted2026-04-28actual
Study start2026-05-01estimated
Primary completion2026-12estimated (month precision)
Study completion2027-05estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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).

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Change in HbA1c

Time frame:Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.