CompletedPhase 3

A Study of TG103 Injection Monotherapy in Treatment of Type 2 Diabetes Mellitus

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial of TG103 Injection Monotherapy Subjects With Type 2 Diabetes Mellitus

Lead sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Asset

TG103

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

465

Study population

Type 2 diabetes

Eligibility highlights

•BMI ≤40

Primary endpoint

•Changes in glycosylated hemoglobin (HbA1c)

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 IDNCT06258148

Org study IDSYSA1803-010

Timeline

Milestones

Study first posted2024-02-14actual

Study start2024-04-15actual

Primary completion2026-01-23actual

Study completion2026-01-23actual

Last update posted2026-03-31actual

Assets

Investigational agents

TG103

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•1.Subjects have diagnosed with type 2 diabetes according to the Guidelines for prevention and treatment of type 2 diabetes in China (2020 Edition), and have been diagnosed with T2DM for at least 8 weeks before screening;

•2.Aged 18 to 75 years (inclusive), no gender limitation;

•3. Body Mass Index (BMI): 18.5≤BMI≤40;

•4. No hypoglycemic drugs have been used within 8 weeks before screening, and the blood glucose control is poor after diet and exercise therapy alone

•5.The continuous use of insulin ≤14 days (except gestational diabetes), and/or the types of hypoglycemic drugs used in combination <3 with the continuous use time ≤4 weeks within 1 year (more than 8 weeks) before screening;

•6.HbA1c must meet the following criteria:

-Screening: 7.5% ≤ HbA1c ≤ 11.0% (Local laboratory)

-Baseline: 7.0% ≤ HbA1c ≤ 10.5% (Central laboratory)

•7.Subjects of childbearing potential must use reliable methods of contraception throughout the study period and at least 3 months after the last dose to avoid pregnancy in female subjects or pregnancy in the male subject's partner;

•8. Willing and able to accurately use home glucose meter for self-glucose monitoring;

•9. Be able to understand and follow the trial procedure, voluntarily participate in the trial and sign the informed consent form.

Exclusion criteria

•1. Type 1 diabetes;

•2. Body weight change more than 5% within 1 month prior to screening;

•3. Received any of the following medications:

1. Prior discontinuation of DPP-4 inhibitors or GLP-1 receptor agonists for efficacy, tolerability, and safety reasons;

2. Systemic glucocorticoid and growth hormone have been used within 8 weeks before screening;

•4. History of ≥2 episodes of grade 3 hypoglycemia within 6 months prior to screening, or grade 3 hypoglycemia between screening to randomization;

•5. Acute complications of diabetes, such as diabetic ketoacidosis and hyperglycemic hyperosmolar status, occurred ≥1 time within 6 months prior to screening;

•6. Severe chronic complications of diabetes (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within 6 months prior to screening

•7. History of acute or chronic pancreatitis prior to screening;

•8. Subjects with clinically significant gastric emptying abnormalities (e.g., gastric outlet obstruction), severe chronic gastrointestinal diseases (e.g., gastroparesis, inflammatory bowel disease, or intestinal obstruction) within 6 months prior to screening, or who have undergone gastrointestinal surgery that affects gastric emptying;

•9. Any of the following cardiovascular events within 6 months prior to screening: decompensated cardiac insufficiency (NYHA class III or IV); history of unstable angina pectoris, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; long QT syndrome or prolonged QTcF interval (QTcF: male >450 ms, female >470 ms) on 12-lead ECG; severe arrhythmias that are evaluated by the investigator to be inappropriate for participation in this clinical trial;

•10. Hemorrhagic stroke or acute ischemic stroke disease occurred within 6 months prior to screening;

•11. History of psychiatric diseases (such as depression, anxiety, etc.) during screening; or symptomatic gallbladder disease; or history of other diseases that may endanger the safety of the subject and that the investigator deems inappropriate for enrollment;

•12. Any type of malignant tumor treated or untreated within 5 years prior to screening (except for clinically cured basal cell carcinoma or carcinoma in situ);

•13. Severe or acute infection within 4 weeks prior to screening, or refractory urinary tract or genital infection within 6 months prior to screening;

•14. Having a significant blood system disease (e.g., aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or red blood cell instability (e.g., malaria) at screening;

•15. Subjects with thyroid dysfunction that cannot be controlled by a stable drug dose at screening, or with clinically significant abnormalities in thyroid function examination results requiring drug treatment at screening;

•16. Personal or family history of medullary thyroid cancer (MTC) or type 2 multiple endocrine tumor syndrome at screening;

•17. Any of the indicators meet the following criteria:

•i. Systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100mmHg at screening or before randomization;

•ii. Laboratory tests show any of the following abnormalities:

1. FPG≥13.9 mmol/L;

2. ALT or AST≥2.5×ULN;

3. Total bilirubin (TBiL) ≥2.0×ULN;

4. Triglyceride >5.7 mmol/L;

5. eGFR<45 mL/(min*1.73 m^2);

6. Serum amylase and/or lipase ≥3×ULN;

7. Hemoglobin <100 g/L;

8. Calcitonin≥50 ng/L(pg/mL);

•iii. Serological examination:

1. Human immunodeficiency virus antibody or treponema pallidum antibody is positive;

2. Hepatitis C antibody is positive, and HCV RNA was higher than the lower limit of the detection reference range;

3. Hepatitis B surface antigen is positive, and the quantitative detection result of HBV DNA was higher than the lower limit of the detection reference range;

•18. Known allergy to the test drug, Empagliflozin, or related excipients;

•19. Subjects who have lost more than 400 mL blood due to blood donation or other reasons within 3 months prior to screening;

•20. Average alcohol intake more than 21 units of alcohol (male)/14 units of alcohol (female) per week within the 3 months prior to screening (1 unit ≈360 mL beer, or 45 mL spirits with 40% alcohol content, or 150 mL wine);

•21. Subject participated in any drug or medical device clinical study within 3 months prior to screening (except for screening failure);

•22. Pregnant or lactating female;

•23. Not suitable for this study in the investigator's opinion.

Endpoints (12)

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

Glycemic / diabetes

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

Cardiometabolic biomarkers

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in weight

Time frame:Baseline through Week 28 and 52

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

Changes in glycosylated hemoglobin (HbA1c)

Time frame:Baseline through Week28

descriptive

Secondary/protocol endpoint

Changes in HbA1c

Time frame:Baseline through Week52

descriptive

Secondary/protocol endpoint

The percentage of HbA1c≤6.5% and the percentage of HbA1c≤7%

Time frame:Week28 and 52

descriptive

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

Time frame:Baseline through Week 28 and 52

change from baseline, improvement

Secondary/protocol endpoint

Change in 2h-postprandial plasma glucose (2h-PPG)

Time frame:Baseline through Week 28 and 52

change from baseline, improvement

Secondary/protocol endpoint

Change in mean 7-point blood glucose curve ， Change in mean postprandial blood glucose increment .

Time frame:Baseline through Week 28 and 52

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change in blood lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol)

Time frame:Baseline through Week 28 and 52

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Incidence of adverse events

Time frame:Week-2 through 52

event count, event

Secondary/protocol endpoint

The occurrence of TG103 anti-drug antibodies (ADA) and neutralizing antibody (NAb)

Time frame:Week 0, 4, 8,16, 28,36, 44,52 and 55

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Proportion of subjects receiving remedial therapy

Time frame:Week 28 and 52

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Blood concentrations of TG103

Time frame:Week 0, 4, 8,16, 28,36, 44,52 and 55

concentration, descriptive

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.