Type 2 Diabetes MellitusPhase 3NCT06258148
A Study of TG103 Injection Monotherapy in Treatment of Type 2 Diabetes Mellitus
A Phase 3 study testing TG103 in people with Type 2 Diabetes Mellitus, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-parallel, multicenter phase 3 clinical trial to evaluate the efficacy of TG103 injection 7.5mg and 15mg once a week monotherapy compared with placebo in subjects with type 2 diabetes with poor glycemic control after diet and exercise. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- TG103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 465 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to 23 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 1. Type 1 diabetes;
- 2. Body weight change more than 5% within 1 month prior to screening;
- 3. Received 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;
- 4. History of ≥2 episodes of grade 3 hypoglycemia within 6 months prior to screening, or grade 3 hypoglycemia between screening to randomization;
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- 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:
- FPG≥13.9 mmol/L;
- ALT or AST≥2.5×ULN;
- Total bilirubin (TBiL) ≥2.0×ULN;
- Triglyceride >5.7 mmol/L;
- eGFR<45 mL/(min*1.73 m^2);
- Serum amylase and/or lipase ≥3×ULN;
- Hemoglobin <100 g/L;
- Calcitonin≥50 ng/L(pg/mL);
- iii. Serological examination:
- Human immunodeficiency virus antibody or treponema pallidum antibody is positive;
- Hepatitis C antibody is positive, and HCV RNA was higher than the lower limit of the detection reference range;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100032
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial of TG103 Injection Monotherapy Subjects With Type 2 Diabetes Mellitus
This is a randomized, double-blind, placebo-parallel, multicenter phase 3 clinical trial to evaluate the efficacy of TG103 injection 7.5mg and 15mg once a week monotherapy compared with placebo in subjects with type 2 diabetes with poor glycemic control after diet and exercise.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- TG103, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG103Drug
TG103 injection, 7.5mg, 15 mg, SC, once a week
PlaceboDrug
Placebo, SC, once a week
| Study group | Role | What they receive |
|---|---|---|
| TG103, 7.5 mg | Experimental | TG103 (7.5 mg) will be administered via subcutaneous injection once a week in subjects with type 2 diabetes. Receives: Drug: TG103 |
| TG103, 7.5 mg placebo | Placebo comparator | Placebo will be administered via subcutaneous injection once a week in subjects with type 2 diabetes. Receives: Drug: Placebo |
| TG103, 15 mg | Experimental | TG103 (15 mg) will be administered via subcutaneous injection once a week in subjects with type 2 diabetes. Receives: Drug: TG103 |
| TG103, 15 mg placebo | Placebo comparator | Placebo will be administered via subcutaneous injection once a week in subjects with type 2 diabetes. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glycosylated hemoglobin (HbA1c)
Measured: Baseline through Week28
Secondary outcomes (11)
Changes in HbA1c
Measured: Baseline through Week52
The percentage of HbA1c≤6.5% and the percentage of HbA1c≤7%
Measured: Week28 and 52
Change in fasting plasma glucose (FPG)
Measured: Baseline through Week 28 and 52
Change in weight
Measured: Baseline through Week 28 and 52
Change in 2h-postprandial plasma glucose (2h-PPG)
Measured: Baseline through Week 28 and 52
Change in mean 7-point blood glucose curve ， Change in mean postprandial blood glucose increment .
Measured: Baseline through Week 28 and 52
Change in blood lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol)
Measured: Baseline through Week 28 and 52
Proportion of subjects receiving remedial therapy
Measured: Week 28 and 52
Incidence of adverse events
Measured: Week-2 through 52
Blood concentrations of TG103
Measured: Week 0, 4, 8,16, 28,36, 44,52 and 55
The occurrence of TG103 anti-drug antibodies (ADA) and neutralizing antibody (NAb)
Measured: Week 0, 4, 8,16, 28,36, 44,52 and 55
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start15 Apr 2024
- Primary completion23 Jan 2026
- Study completion23 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258148
- Sponsor's protocol ID
- SYSA1803-010
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial of TG103 Injection Monotherapy Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06258148
- Acronym / sponsor ID
- SYSA1803-010
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-parallel, multicenter phase 3 clinical trial to evaluate the efficacy of TG103 injection 7.5mg and 15mg once a week monotherapy compared with placebo in subjects with type 2 diabetes with poor glycemic control after diet and exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TG103, 7.5 mg | Experimental | Drug: TG103TG103 (7.5 mg) will be administered via subcutaneous injection once a week in subjects with type 2 diabetes. |
| TG103, 7.5 mg placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered via subcutaneous injection once a week in subjects with type 2 diabetes. |
| TG103, 15 mg | Experimental | Drug: TG103TG103 (15 mg) will be administered via subcutaneous injection once a week in subjects with type 2 diabetes. |
| TG103, 15 mg placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered via subcutaneous injection once a week in subjects with type 2 diabetes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (39 listed)
- 1. Type 1 diabetes;
- 2. Body weight change more than 5% within 1 month prior to screening;
- 3. Received any of the following medications:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TG103TG103 injection, 7.5mg, 15 mg, SC, once a week | Drug | TG103, 15 mg, TG103, 7.5 mg |
| PlaceboPlacebo, SC, once a week | Drug | TG103, 15 mg placebo, TG103, 7.5 mg placebo |
Primary outcome
Changes in glycosylated hemoglobin (HbA1c)
Time frame: Baseline through Week28
11 secondary outcomes
Changes in HbA1c
Time frame: Baseline through Week52
The percentage of HbA1c≤6.5% and the percentage of HbA1c≤7%
Time frame: Week28 and 52
Change in fasting plasma glucose (FPG)
Time frame: Baseline through Week 28 and 52
Change in weight
Time frame: Baseline through Week 28 and 52
Change in 2h-postprandial plasma glucose (2h-PPG)
Time frame: Baseline through Week 28 and 52
Change in mean 7-point blood glucose curve ， Change in mean postprandial blood glucose increment .
Time frame: Baseline through Week 28 and 52
Change in blood lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol)
Time frame: Baseline through Week 28 and 52
Proportion of subjects receiving remedial therapy
Time frame: Week 28 and 52
Incidence of adverse events
Time frame: Week-2 through 52
Blood concentrations of TG103
Time frame: Week 0, 4, 8,16, 28,36, 44,52 and 55
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TG103 in people with Type 2 Diabetes Mellitus, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in glycosylated hemoglobin (HbA1c) (time frame: Baseline through Week28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.