DelfaGLP-1 Atlas

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CompletedPhase 3

A Study of TG103 Injection Combined With Metformin in Treatment of Type 2 Diabetes Mellitus

A Multicenter, Randomized, Open-label, Controlled Phase 3 Trial of TG103 Injection in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus

Assets

Dulaglutide / TG103

Listed sites

1

Recruiting sites

—

Enrollment

632

actual

Study population

Type 2 diabetes

Key I/E criterion

•BMI ≤40

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 IDNCT06235086
Org study IDSYSA1803-009

Timeline

Milestones

Study first posted2024-01-31actual
Study start2024-04-08actual
Primary completion2026-02-03actual
Study completion2026-02-03actual
Last update posted2026-04-03actual

Assets

Investigational agents

DulaglutideTG103

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Subjects have diagnosed with type 2 diabetes according to the Guidelines for prevention and treatment of type 2 diabetes in China (2020 Edition), T2DM was diagnosed at least 8 weeks before screening;
•Aged 18 to 75 years (inclusive), no gender limitation;
•Body Mass Index (BMI): 18.5≤BMI≤40;
•Received stable dose of metformin hydrochloride monotherapy for ≥8 weeks before screening and metformin dose ≥1500 mg/ day ;
•HbA1c must meet the following criteria:
–Screening: 7.5% ≤ HbA1c ≤ 11.0% (Local laboratory)
–Baseline: 7.0% ≤ HbA1c ≤ 10.5% (Central laboratory)
•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;
•Willing and able to accurately use home glucose meter for self-glucose monitoring;
•Be able to understand and follow the trial procedure, voluntarily participate in the trial and sign the informed consent form.

Exclusion criteria

•Type 1 diabetes;
•Body weight change more than 5% within 1 month prior to screening;
•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,or other drugs affecting glucose metabolism have been used within 8 weeks before screening;

•History of ≥2 episodes of grade 3 hypoglycemia within 6 months prior to screening, or grade 3 hypoglycemia between screening to randomization;
•Acute complications of diabetes, such as diabetic ketoacidosis and hyperglycemic hyperosmolar status, occurred ≥1 time within 6 months prior to screening;
•Severe chronic complications of diabetes (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within 6 months prior to screening
•History of acute or chronic pancreatitis prior to screening;
•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;
•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; or 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;
•Hemorrhagic stroke or acute ischemic stroke disease occurred within 6 months prior to screening;
•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;
•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);
•Severe infection within 4 weeks prior to screening, or refractory urinary tract or genital infection within 6 months prior to screening;
•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;
•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;
•Personal or family history of medullary thyroid cancer (MTC) or type 2 multiple endocrine tumor syndrome at screening;
•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;

•Known allergy to the test drug, Dulaglutide, Empagliflozin, or related excipients;
•Subjects who have lost more than 400 mL blood due to blood donation or other reasons within 3 months prior to screening;
•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);
•Subject participated in any drug or medical device clinical study within 3 months prior to screening (except for screening failure);
•Pregnant or lactating female;
•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
7
Safety / tolerability / PK
3
Weight & body composition
1
Cardiometabolic biomarkers
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in weight from baseline at week 28 and 52

Time frame:Baseline through Week28 and 52

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

7 endpoints
Primary/protocol endpoint

Changes in glycosylated hemoglobin (HbA1c) from baseline at 28 weeks of treatment

Time frame:Baseline through Week28

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Changes in HbA1c from baseline at 52 weeks of treatment

Time frame:Baseline through Week52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

The percentage of HbA1c≤6.5% and the percentage of HbA1c≤7% at week 28 and 52

Time frame:Week28 and 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG) from baseline at week 28 and 52

Time frame:Baseline through Week28 and 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in 2h-postprandial plasma glucose (2h-PPG) from baseline at week 28 and 52

Time frame:Baseline through Week28 and 52

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Mean 7 point blood glucose curve from baseline at week 28 and 52. Change in mean postprandial blood glucose increment from baseline at week 28 and 52.

Time frame:Baseline through Week28 and 52

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Proportion of subjects receiving remedial therapy at week 28 and 52

Time frame:Week28 and 52

threshold achievement, event

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change in blood lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) from baseline at week 28 and 52.

Time frame:Baseline through Week28 and 52

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Incidence of adverse events

Time frame:Week-2 through 52

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Blood concentrations of TG103

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

Plasma concentration (steady state)

concentration, descriptive

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

Immunogenicity (ADA)

descriptive

componentsImmunogenicity (ADA)

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.