Optimum 2

Active not recruitingPhase 3

A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus

A Multicenter, Randomized, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Subjects With Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination With Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas

Lead sponsor

Gan & Lee Pharmaceuticals.

Assets

GZR18 / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

1,100

estimated

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06778967

Org study IDGZR18-T2DM-302

Timeline

Milestones

Study first posted2025-01-16actual

Study start2025-02-13actual

Last update posted2025-11-25actual

Primary completion2026-12-11estimated

Study completion2026-12-11estimated

Assets

Investigational agents

GZR18 Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•T2DM is diagnosed for at least 12 weeks according to the diagnostic criteria of diabetes mellitus issued by the World Health Organization (WHO) in 1999 and the supplementary diagnostic criteria of WHO in 2011 (HbA1c diagnosis is recommended).

•Antidiabetic drugs that meet any of the following within 8 weeks before screening:

–A stable dose of metformin hydrochloride monotherapy at a dose of ≥ 1500 mg/day or the maximum tolerated dose ;

–A stable dose of metformin (≥ 1500 mg/day or the maximum tolerated dose ) in combination with SGLT2 inhibitors;

–A stable dose of metformin (≥1500 mg/day or a maximum tolerated dose < 1500 but ≥ 1000 mg/day) in combination with a stable daily dose of sulfonylureas.

•HbA1c ≥ 7.5% and ≤ 11% at screening (central laboratory).

•BG < 15 mmol/L at screening (central laboratory).

Exclusion criteria

•Type 1 diabetes mellitus or special type of diabetes mellitus.

•Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar state within 6 months before screening, or diabetic ketosis at screening/before randomization.

•Severe chronic complications of diabetes (such as proliferative retinopathy or maculopathy, diabetic painful neuropathy, intermittent claudication, or diabetic foot) at screening or before randomization.

•History of acute or chronic pancreatitis and pancreatic injury before screening.

•History or relevant family history of medullary thyroid cancer, multiple endocrine neoplasia (MEN) 2A or 2B before screening.

•Any laboratory test indicator meeting the following criteria at screening or before randomization:

•Calcitonin level ≥ 50 ng/L (pg/mL) at screening.

•ALT ≥ 3.0 × upper limit of normal (ULN) or AST ≥ 3.0 × ULN or total bilirubin ≥ 2.0 × ULN.

•Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2, calculated using CKD-EPI equation (see Appendix 3).

•Fasting triglyceride (TG) ≥ 5.7 mmol/L or 500 mg/dL.

•Blood amylase or lipase > 1.5 × ULN.

•Hemoglobin ≤ 100 g/L for women and ≤ 110 g/L for men.

Endpoints (7)

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.

Coverage by outcome category

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Change from baseline in weight (kg)

Time frame:week 44

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percent change in weight from baseline (%)

Time frame:week 44

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Proportion of subjects with ≥ 5% and 10% decrease in weight from baseline.

Time frame:week 44

≥5% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c)(%)

Time frame:Baseline, Week 44

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from baseline in mean 7-point self-measured blood glucose (SMBG)

Time frame:week 44

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Proportion of subjects with salvage therapy.

Time frame:week 44

threshold achievement, event

Secondary/protocol endpoint

Treatment emergent adverse events (TEAEs)

Time frame:week 44

Treatment-emergent AEs (any)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 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 1, 2026 snapshot.