Type 2 Diabetes MellitusPhase 2NCT05063253
A Study of TG103 Injection in Overweight/Obese Subjects With Type 2 Diabetes
A Phase 2 study testing TG103 in people with Type 2 Diabetes Mellitus, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd..
Trial summary
The main purpose of this study is to evaluate the efficacy, safety, PK and PD characteristics of different doses of TG103 injection in overweight/obese subjects with type 2 diabetes mellitus. 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
- 208 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Mar 2024
- Phase
- Phase 2
- 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
- Subjects have diagnosed with type 2 diabetes according to the Guidelines for prevention and treatment of type 2 diabetes in China (2020 Edition);
- Aged 18 to 75 years (inclusive), no gender limitation;
- Body mass index (BMI) ≥ 24.0 kg/m^2 with stable body weight (less than 5% self-reported change within 3 months);
- Subjects diagnosed with type 2 diabetes ≤ 3 years, and not on medication or with a history of regular medication for no more than 1 week within the 3 months prior to screening (subjects with a history of medication only include those with a history of single-agent oral medication and a history of short-term intensive insulin therapy (≤ 2 weeks)); 5.7.5% ≤ HbA1c ≤ 10.0%;
- 6.Subjects of childbearing potential must use reliable methods of contraception from the date of signing an informed consent to at least 3 months after the last dose; 7. The subject fully understand the trial and possible adverse reactions, has the ability to communicate properly with the investigator and comply with the research protocol; 8.Voluntarily participate in the trial and sign the informed consent form.
Who cannot join
- Fasting plasma glucose ≥ 13.9 mmol/L at screening or a history of severe hypoglycemia (Serious event requiring help from others with changes in consciousness and/or body) within 6 months prior to screening;
- Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg during screening;
- Have one or more positive tests in anti-human immunodeficiency virus antibody or anti-treponema pallidum-specific antibody;
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≥2.5x upper limit of normal (ULN), or Total bilirubin (TBiL)≥1.5x ULN, or triglyceride > 5.7 mmol/L or eGFR < 60 mL/(min*1.73 m^2) during the screening period;
- Subjects with hematological diseases (e.g., aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or erythrocyte instability (e.g., malaria), or hemoglobin<100 g/L;
- Hypercortisolism, polycystic ovary syndrome, abnormal thyroid function (those requiring medication or who have not reached a stable dose of treatment in 3 months prior to screening), etc. or other diseases that may affect blood glucose metabolism;
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- Have a personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia, or other genetic diseases that are susceptible to medullary cancer, or calcitonin ≥ 50 ng/L(pg/mL);
- Acute complications of diabetes (including diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis) occurred once or more within 3 months or twice or more within 6 months before screening;
- Proliferative diabetic retinopathy, foot ulcers/gangrene, and manifestations of peripheral neuropathy with obvious symptoms (e.g., gastroparesis, urinary retention, intestinal obstruction, urinary incontinence, and painful peripheral neuropathy);
- Subjects with degree II or III atrioventricular block in 12-lead ECG (except for subjects who use the pacemaker), long QT syndrome or prolonged QTc interval (QTcF: >450 ms for males, >470 ms for females), or signs of clinically significant localised ischemic heart disease during the screening period; or those with other heart diseases that are judged by the investigator to be unsuitable for entry into the study;
- Any of the following cardiovascular and cerebrovascular events within half a year before screening: unstable angina pectoris requiring hospitalization, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention (diagnostic angiography is allowed), moderate to severe congestive heart failure (NYHA grade III or IV), atrial or ventricular arrhythmia requiring hospitalization (such as atrial fibrillation and ventricular tachycardia), pacemaker or defibrillator implantation, transient ischemic attack or cerebrovascular accident (e.g. stroke), or those with coronary artery bypass grafting or revascularization planned during the study period;
- Have chronic or acute pancreatitis ( or have a history of recurrent acute pancreatitis), or serum amylase and/or lipase ≥ 3x ULN (If lipase cannot be detected in some centers, it is acceptable to judge only based on amylase),or severe gastrointestinal disease, such as confirmed reflux esophagitis or gallbladder disease, or any disease impacting gastric emptying (such as gastric bypass surgery, pyloric stenosis, except for appendectomy) or gastrointestinal diseases that may be aggravated by GLP-1 analogues; for subjects with a history of gallbladder stones (gallstone removal or lithotripsy) and/or cholecystectomy, access to the study will be determined by investigator after assessing the risk if there are no further sequelae;
- History of severe respiratory tract, blood system, central nervous system diseases (e.g., epilepsy, etc.), or history of malignant tumor (except for basal cell carcinoma or carcinoma in situ that has been clinically cured), mental diseases (e.g., depression, anxiety, etc.), or history of other diseases that may endanger the safety of the subjects and are considered unsuitable for this study in the investigator's opinion;
- Subjects who have undergone major surgery within 3 months before screening, or have ongoing severe or acute infection within 4 weeks before screening, or whose white blood cell count exceeds 10% of the upper limit of normal during the screening period;
- Use of drugs that can affect glucose metabolism or directly reduce gastrointestinal motility within the 3 months prior to screening or expected during the course of the study, including the cumulative use of systemic glucocorticoids (topical, intraocular and inhaled preparations), immunosuppressants and cytotoxic drugs for more than 7 days; Large doses of thiazide diuretics (hydrochlorothiazide>100 mg/d, chlorothiazide> 2 g/d, indapamide> 5 mg/d, chlorthalidone> 100 mg/d), anticholinergics, antispasmodics, etc. for more than 7 consecutive days;
- Have taken prescription or over-the-counter medications for weight loss (e.g., orlistat, sibutramine, rimonabant, phenylpropanolamine, or chlorphenimiindole, etc) within 3 months prior to screening; or have undergone surgery that can cause weight instability;
- Drugs that may cause significant weight gain have been used or are being used within 3 months before screening, including tricyclic antidepressants, atypical antipsychotics and mood stabilizers (e.g., midazolam, amitriptyline, mirtazapine, paroxetine, phenyl valproic acid and its derivatives and lithium), etc;
- Have a serious history of drug or food allergy, or may be allergic to the investigational product according to the judgment of the investigator;
- Lost more than 400 mL of blood due to blood donation or other reasons within 3 months before the screening period;
- Average alcohol intake more than 21 units of alcohol (male)/14 units of alcohol (female) per week within the 3 months prior to screening;
- Regular consumption of caffeine more than 600 mg per day within the 3 months prior to screening;
- Smoke more than 20 cigarettes per day within 3 months prior to screening;
- Have skin abnormalities or dermatitis within a radius of 2 cm of the administration site;
- Participation in other drug studies within 3 months prior to screening and the last received test drug less than 3 months prior to screening; or subjects out of the group due to adverse events in the previous study; or attempted to participate in other drug trials during the study;
- Pregnant (blood pregnancy test positive in screening period) or lactating female;
- Vaccinated within 28 days before screening or planned to be vaccinated during the study;
- Not suitable for this study in the investigator's opinion.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy of TG103 Injection in Overweight/Obese Subjects With Type 2 Diabetes Mellitus
The main purpose of this study is to evaluate the efficacy, safety, PK and PD characteristics of different doses of TG103 injection in overweight/obese subjects with type 2 diabetes mellitus.
Read the detailed description
This study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of TG103 injection in subjects with type 2 diabetes mellitus combined with overweight/obesity. The study will consist of 3 periods: an approximately 4-week screening period, a 20-week treatment period, and a 3-week safety follow-up period. Eligible subjects will be randomized in a 1:1:1:1 ratio into four paralleled dose groups (15 mg, 22.5 mg ,30 mg and placebo) with 52 subjects in each group. Within each group, subjects will receive TG103 injection or placebo subcutaneously (SC) once a week (QW) over a period of 20 weeks. Each group will be started at a low dose of 7.5 mg and gradually up-titrated at weekly intervals until the target dose.
- 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
Also called Administered SC
TG103 injection, SC, once weekly
PlaceboDrug
Also called Administered SC
Placebo, SC, once weekly
| Study group | Role | What they receive |
|---|---|---|
| TG103, 15 mg | Experimental | TG103 (15 mg) will be administered via subcutaneous injection once weekly. Receives: Drug: TG103 |
| TG103, 22.5 mg | Experimental | TG103 (22.5 mg) will be administered via subcutaneous injection once weekly. Receives: Drug: TG103 |
| TG103, 30 mg | Experimental | TG103 (30 mg) will be administered via subcutaneous injection once weekly. Receives: Drug: TG103 |
| Placebo | Placebo comparator | Placebo will be administered via subcutaneous injection once weekly. 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) from baseline to week 20
Measured: Baseline through Day 141 (the end of the 20-week treatment)
Secondary outcomes (12)
Change in body weight from baseline to week 20
Measured: Baseline through Day155 (the end of the follow-up)
Change in body mass index (BMI) from baseline to week 20
Measured: Baseline through Day155 (the end of the follow-up)
Change in waist circumference from baseline to week 20
Measured: Baseline through Day155 (the end of the follow-up)
Change in waist-hip ratio from baseline to week 20
Measured: Baseline through Day155 (the end of the follow-up)
Change in blood pressure(systolic and diastolic blood pressure) from baseline to week 20
Measured: Baseline through Day155 (the end of the follow-up)
Change in blood lipid from baseline to week 20
Measured: Baseline through Day155 (the end of the follow-up)
Proportion of subjects with a baseline weight loss of more than 5%
Measured: Baseline through Day155 (the end of the follow-up)
Incidence of adverse events
Measured: Baseline through Day155 (the end of the follow-up)
Minimum steady-state plasma drug concentration during a dosage interval (Cmin, SS)
Measured: Day1, 29, 57, 85 and 113
Change in fasting blood glucose from baseline to week 20
Measured: Baseline through Day 141 (the end of the 20-week treatment)
Change in 2-hour postprandial blood glucose from baseline to week 20
Measured: Baseline through Day 141 (the end of the 20-week treatment)
The occurrence of TG103 anti-drug antibodies (ADA) and neutralizing antibody (Nab).
Measured: Day1, 29, 57, 85, 113 and 155
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dalong Zhu, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063253
- Sponsor's protocol ID
- SYSA1803-CSP-006
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy of TG103 Injection in Overweight/Obese Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05063253
- Acronym / sponsor ID
- SYSA1803-CSP-006
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2021 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 1 Oct 2021 (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.
The main purpose of this study is to evaluate the efficacy, safety, PK and PD characteristics of different doses of TG103 injection in overweight/obese subjects with type 2 diabetes mellitus.
Detailed description
This study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of TG103 injection in subjects with type 2 diabetes mellitus combined with overweight/obesity. The study will consist of 3 periods: an approximately 4-week screening period, a 20-week treatment period, and a 3-week safety follow-up period. Eligible subjects will be randomized in a 1:1:1:1 ratio into four paralleled dose groups (15 mg, 22.5 mg ,30 mg and placebo) with 52 subjects in each group. Within each group, subjects will receive TG103 injection or placebo subcutaneously (SC) once a week (QW) over a period of 20 weeks. Each group will be started at a low dose of 7.5 mg and gradually up-titrated at weekly intervals until the target dose.
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, 15 mg | Experimental | Drug: TG103TG103 (15 mg) will be administered via subcutaneous injection once weekly. |
| TG103, 22.5 mg | Experimental | Drug: TG103TG103 (22.5 mg) will be administered via subcutaneous injection once weekly. |
| TG103, 30 mg | Experimental | Drug: TG103TG103 (30 mg) will be administered via subcutaneous injection once weekly. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered via subcutaneous injection once weekly. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects have diagnosed with type 2 diabetes according to the Guidelines for prevention and treatment of type 2 diabetes in China (2020 Edition);
- Aged 18 to 75 years (inclusive), no gender limitation;
- Body mass index (BMI) ≥ 24.0 kg/m^2 with stable body weight (less than 5% self-reported change within 3 months);
- Subjects diagnosed with type 2 diabetes ≤ 3 years, and not on medication or with a history of regular medication for no more than 1 week within the 3 months prior to screening (subjects with a history of medication only include those with a history of single-agent oral medication and a history of short-term intensive insulin therapy (≤ 2 weeks)); 5.7.5% ≤ HbA1c ≤ 10.0%;
- 6.Subjects of childbearing potential must use reliable methods of contraception from the date of signing an informed consent to at least 3 months after the last dose; 7. The subject fully understand the trial and possible adverse reactions, has the ability to communicate properly with the investigator and comply with the research protocol; 8.Voluntarily participate in the trial and sign the informed consent form.
Key exclusion criteria (27 listed)
- Fasting plasma glucose ≥ 13.9 mmol/L at screening or a history of severe hypoglycemia (Serious event requiring help from others with changes in consciousness and/or body) within 6 months prior to screening;
- Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg during screening;
- Have one or more positive tests in anti-human immunodeficiency virus antibody or anti-treponema pallidum-specific antibody;
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≥2.5x upper limit of normal (ULN), or Total bilirubin (TBiL)≥1.5x ULN, or triglyceride > 5.7 mmol/L or eGFR < 60 mL/(min*1.73 m^2) during the screening period;
- Subjects with hematological diseases (e.g., aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or erythrocyte instability (e.g., malaria), or hemoglobin<100 g/L;
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 |
|---|---|---|
| TG103Also: Administered SCTG103 injection, SC, once weekly | Drug | TG103, 15 mg, TG103, 22.5 mg, TG103, 30 mg |
| PlaceboAlso: Administered SCPlacebo, SC, once weekly | Drug | Placebo |
Primary outcome
Changes in glycosylated hemoglobin (HbA1c) from baseline to week 20
Time frame: Baseline through Day 141 (the end of the 20-week treatment)
12 secondary outcomes
Change in body weight from baseline to week 20
Time frame: Baseline through Day155 (the end of the follow-up)
Change in body mass index (BMI) from baseline to week 20
Time frame: Baseline through Day155 (the end of the follow-up)
Change in waist circumference from baseline to week 20
Time frame: Baseline through Day155 (the end of the follow-up)
Change in waist-hip ratio from baseline to week 20
Time frame: Baseline through Day155 (the end of the follow-up)
Change in blood pressure(systolic and diastolic blood pressure) from baseline to week 20
Time frame: Baseline through Day155 (the end of the follow-up)
Change in blood lipid from baseline to week 20
Time frame: Baseline through Day155 (the end of the follow-up)
Proportion of subjects with a baseline weight loss of more than 5%
Time frame: Baseline through Day155 (the end of the follow-up)
Incidence of adverse events
Time frame: Baseline through Day155 (the end of the follow-up)
Minimum steady-state plasma drug concentration during a dosage interval (Cmin, SS)
Time frame: Day1, 29, 57, 85 and 113
Change in fasting blood glucose from baseline to week 20
Time frame: Baseline through Day 141 (the end of the 20-week treatment)
Change in 2-hour postprandial blood glucose from baseline to week 20
Time frame: Baseline through Day 141 (the end of the 20-week treatment)
The occurrence of TG103 anti-drug antibodies (ADA) and neutralizing antibody (Nab).
Time frame: Day1, 29, 57, 85, 113 and 155
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Dalong Zhu principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TG103 in people with Type 2 Diabetes Mellitus, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd..
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 5 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Le Wang (+86-15511312686, wangle@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in glycosylated hemoglobin (HbA1c) from baseline to week 20 (time frame: Baseline through Day 141 (the end of the 20-week treatment)). 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 1 Oct 2021.