GLP-1 Peptide Atlas, by Delfa

UnknownPhase 2

A Study of TG103 Injection in Type 2 Diabetes Subjects

A Multicenter, Randomized, Double-blind, Placebo-controlled，Dulaglutide-controlled Phase Ⅱ Trial Exploring Optimal Dosing Regimen for TG103 Injection Monotherapy in Type 2 Diabetes

Lead sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Assets

Dulaglutide / TG103

Listed sites

Recruiting sites

—

Enrollment

240

estimated

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤40•HbA1c ≤11%

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 IDNCT05348122

Org study IDSYSA1803-008

Timeline

Milestones

Study first posted2022-04-27actual

Last update posted2022-06-13actual

Study start2022-06-15estimated

Primary completion2023-11-01estimated

Study completion2023-11-01estimated

Assets

Investigational agents

Dulaglutide TG103

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

•Clinical diagnosis of type 2 diabetes ;

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

•Body Mass Index (BMI): 18.5≤BMI≤40;

•Poor blood glucose control after diet and exercise alone without hypoglycemic drug treatment. Not treated with hypoglycemic drugs is defined as:Have not received hypoglycemic drugs before screening, or have received hypoglycemic drugs before screening, but have not received hypoglycemic drugs within 8 weeks before screening; and continuous use of insulin for no more than 14 days (except gestational diabetes) and/or the continuous use of another hypoglycemic drug for no more than 4 weeks within 1 year prior to screening;

•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;

•Must be 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;

•Receive any of the following medications:Prior discontinuation of DPP-4 inhibitors or GLP-1 receptor agonists for efficacy, tolerability, and safety reasons;Systemic glucocorticoid and growth hormone have been used within 8 weeks before screening or before randomization;

•History of grade 3 hypoglycemia ≥2 times within 6 months prior to screening, or grade 3 hypoglycemia prior to screening to randomization;

•Acute complications of diabetes, such as diabetic ketoacidosis and hyperglycemia, occurred ≥1 time within 6 months prior to screening, or prior to randomization;

•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, or acute or chronic pancreatitis prior to randomization;

•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 prior to randomization, long-term use of drugs that directly affect gastrointestinal motility, or gastrointestinal surgery that affects gastric emptying;

•Any of the following cardiovascular events within 6 months prior to screening, or prior to randomization: unstable angina pectoris, myocardial infarction, coronary artery bypass grafting, coronary stent implantation, moderate or severe congestive heart failure (NYHA grade III or IV), atrial or ventricular arrhythmia (e.g., atrial fibrillation, ventricular tachycardia, etc.), pacemaker or defibrillator implantation; Or subjects with Ⅱ or Ⅲ degree atrioventricular block, long QT syndrome or prolonged QTcF interval (QTcF: male >450 ms, female >470 ms) on 12-lead ECG, or signs of heart disease with significant clinical symptoms at screening;

•Hemorrhagic stroke or acute ischemic stroke disease occurred within 6 months prior to screening, or prior to randomization;

•Having a history of serious respiratory tract, central nervous system (such as epilepsy, etc.) and psychiatric diseases (such as depression, anxiety, etc.) during screening; Or have a 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 or prior to randomization (except clinically cured basal cell carcinoma or carcinoma in situ);

•Severe or acute 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 or prior to randomization;

•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;

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

•Any of the following abnormalities during screening or prior to randomization of laboratory tests:FPG≥13.9 mmol/L;ALT or AST≥2.5×ULN;Total bilirubin (TBiL) ≥1.5×ULN;Triglyceride >5.7 mmol/L;eGFR<60 mL/(min*1.73 m^2);Serum amylase and/or lipase ≥3×ULN (if lipase cannot be detected in some centers, amylase alone is acceptable);Hemoglobin <100 g/L;Calcitonin≥50 ng/L(pg/mL);

•Serological examination:Human immunodeficiency virus antibody or treponema pallidum antibody is positive;Hepatitis C antibody is positive;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, Empagliflozin , or related excipients;

•Subjects who underwent major surgery within 3 months prior to screening, or who 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

Safety / tolerability / PK

Weight & body composition

Cardiometabolic biomarkers

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in weight from baseline to week 9 and 17

Time frame:Baseline through Day57 and 113

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

Changes in glycosylated hemoglobin (HbA1c) from baseline to week 17

Time frame:Baseline through Day 113

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Changes in glycosylated hemoglobin (HbA1c) from baseline to week 9

Time frame:Baseline through Day57

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 9 and 17

Time frame:Day57 and 113

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG) from baseline to week 9 and 17

Time frame:Baseline through Day57 and 113

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Mean postprandial blood glucose increment and change in mean postprandial blood glucose from baseline at 7-point Self-monitored Blood Glucose (SMBG) Profile.

Time frame:Baseline through Day113

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in 7-point Self-monitored Blood Glucose (SMBG) Profile.

Time frame:Baseline through Day113

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) from baseline to week 17.

Time frame:Baseline through Day113

change from baseline, improvement

componentsTriglycerides, change, Total cholesterol, change, HDL-C, change, LDL-C, change

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Proportion of subjects receiving remedial therapy at week 17

Time frame:Day113

threshold achievement, event

Secondary/protocol endpoint

Number of TEAEs and SAEs from baseline to week 17

Time frame:Day-14 through Day 113

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

Ctrough will be measured once every 4 week until week 17

Time frame:Day1, 29, 57, 85 and 113

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Day1, 29, 57, 85, 113 and127

Immunogenicity (ADA)

categorical status, event

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.