Type 2 DiabetesPhase 1NCT04790006
A Study of TG103 in Subjects With Type 2 Diabetes
A Phase 1 study testing TG103 in people with Type 2 Diabetes, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
The main purpose of this study is to assess the safety and tolerability of multiple ascending doses of TG103 in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- 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
- 54 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Mar 2022
- Phase
- Phase 1
- 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 who fully understand the test content and possible adverse reactions and voluntarily participate in the trial and sign the informed consent form;
- 2.Age: 18 to 75 years of age inclusive; no gender limitation;
- 3. Weight：body mass index (BMI) within the range of 18.5-35 kg/m2 (inclusive), BMI = weight (kg) / height 2 (m2);
- 4. Patients have diagnosed with type 2 diabetes ≤ 3 years according to the World Health Organization (WHO1999) classification; and not on medication or without a history of regular medication for more than 1 week in the 3 months prior to screening (subjects with a history of medication only include those with a history of oral medication and a history of short-term intensive insulin therapy (≤ 2 weeks));
- 5. 7.0% ≤ 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 has the ability to communicate properly with the researcher and willing to fully comply with the research protocol.
Who cannot join
- 1. Fasting plasma glucose ≥13.9mmol/L or a history of severe hypoglycemia (blood sugar below 2.2mmol/L);
- 2. Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg during screening;
- 3. During the screening period, the white blood cell count fall outside the reference range by 10%, or hemoglobin<100g / L;
- 4. Have one or more positive tests in Hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti- Treponema pallidum-specific antibody;
- 5. Aspartate aminotransferase(AST) or Alanine aminotransferase (ALT) > 2.5x upper limit of normal (ULN), or triglyceride > 5.7mmol/L or eGFR<60 mL/（min*1.73 m2）during the screening period;
- 6. Hypercortisolism, polycystic ovary syndrome, abnormal thyroid function (those who need to be given medication or who have not reached clinical stability after treatment and whose medication still needs to be adjusted), etc. or other diseases that may affect blood glucose metabolism.
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- 7. 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; 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;
- 8. Acute complications of diabetes (including diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis and hypoglycemia coma);
- 9. 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);
- 10. Lost more than 400 ml of blood due to blood donation or other reasons within 3 months before the screening period;
- 11. During 3 months prior to screening through the entire study period, subjects used or plan to use drugs that may affect blood glucose metabolism or directly reduce gastrointestinal motility (e.g., anticholinergic drugs, antispasmodic, 5-HT3 antagonists, dopamine antagonists, and opioids), or oral and intramuscular injections of systemic corticosteroids, or inhalation or intranasal use of potent steroidal drugs with high systemic absorption; subjects regularly used thiazide diuretics within the 3 months prior to screening (Continuous medication > 1 week), or will use high doses of thiazide diuretics during the study period (hydrochlorothiazide>100 mg/d, chlorothiazide> 2 g/d, indapamide> 5 mg/d, chlorthalidone> 100 mg/d);
- 12. During the screening period, subjects with second degree or third degree atrioventricular block (except for subjects who use the pacemaker), long QT syndrome or prolonged QTc interval (male>450ms, female>470ms), or those with significant clinical symptoms of ischemic heart disease; or those with other heart diseases that are judged by the investigator to be unsuitable for entry into the study;
- 13. 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). Subjects with 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;
- 14. Have chronic or acute pancreatitis ( or have a history of chronic pancreatitis or acute pancreatitis) or severe gastrointestinal disease, such as confirmed reflux esophagitis or gallbladder disease, or any impact on gastric emptying (such as gastric bypass surgery, pyloric stenosis, except for appendectomy) or gastrointestinal diseases that may be aggravated by GLP-1 analogues; for patients with a history of gallbladder stones (gallstone removal or lithotripsy) and/or cholecystectomy, if there are no further sequelae, the entering of the study will be determined by researchers after assessing the risk;
- 15.Have a history of severe respiratory, blood system, and central nervous system (e.g. epilepsy) diseases; or have a history of malignant tumors or mental illnesses (such as depression, anxiety, etc.); or have other medical conditions that may endanger the safety of the subject and the investigator believes it is not suitable for inclusion;
- 16. Have had undergone major surgery within 3 months before screening, or had ongoing severe or acute infection within 4 weeks before screening;
- 17. Have a serious history of drug or food allergy, or may be allergic to the investigational product according to the judgment of the researcher;
- 18. Have taken prescription or over-the-counter medications for weight loss (e.g., orlistat, sibutramine, rimonabant, phenylpropanolamine, or chlorambucil) within 3 months prior to screening; or have undergone surgery that can cause weight instability; or have had a significant change in weight (>10% change);
- 19. Average alcohol intake is more than 21 units of alcohol (male)/14 units of alcohol (female) per week (1 unit ≈ 360mL beer, or 45mL spirits with 40% alcohol content, or 150mL wine) within the 3 months prior to screening;
- 20. Regularly consumption of caffeine is more than 600 mg of per day within the 3 months prior to screening (1 cup of coffee contains about 100 mg of caffeine, 1 cup of tea contains about 30 mg of caffeine, and 1 can of cola contains about 20 mg of caffeine);
- 21. Smoke more than 20 cigarettes per day within 3 months prior to screening;
- 22. Have skin abnormalities (such as: dermatitis) within a radius of 2cm of the administration site;
- 23.Participated in other clinical trial involving an investigational product within 3 months before the screening and the time of the last dose of the study drug is less than 3 months before the screening of this trial; or subjects withdrawn from the previous study due to an adverse event; or plan to participate other clinical trial during the study period;
- 24. Pregnant (blood pregnancy test positive in screening period) and lactating female;
- 25. Not suitable for this study in the researcher's opinion.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Multiple Ascending Dose Phase Ib Study in Subjects With Type 2 Diabetes to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TG103 Injection
The main purpose of this study is to assess the safety and tolerability of multiple ascending doses of TG103 in subjects with type 2 diabetes.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled, multicenter, dose-escalating study to characterize the safety (including the anti-drug antibodies(ADA)), tolerability pharmacokinetics (PK) and pharmacodynamic parameters（PD）of TG103. The study will consist of 3 periods: an approximately 2-week lead-in period, followed by a 12-week treatment period, and a 3-week safety follow-up period. Three dose groups (7.5mg, 15mg and 22.5mg) of subjects will be enrolled and dosed sequentially; 12
- Conditions
- Type 2 Diabetes
- 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
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| TG103 | Experimental | TG103 will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes. Receives: Drug: TG103 |
| Placebo | Placebo comparator | Placebo will be administered via subcutaneous injection once weekly 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.
Safety and tolerability assessed by incidence and severity of adverse events
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: up to 15 weeks
Secondary outcomes (7)
Area under the plasma concentration versus time curve (AUC)
PK parameters after administration of of TG103
Measured: Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78
glycosylated hemoglobin (HbA1c)
Pharmacodynamic (PD) parameters after administration of of TG103
Measured: Day15, 29, 43, 57,71, and 78,
The occurrence of TG103 anti-drug antibodies (ADA)
AD Aafter administration of of TG103
Measured: up to 15 weeks
Peak Plasma Concentration (Cmax),
PK parameters after administration of of TG103
Measured: Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78
Time to maximum plasma concentration (Tmax)
PK parameters after administration of of TG103
Measured: Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78
Half time (t1/2),
PK parameters after administration of of TG103
Measured: Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78
Apparent clearance (CL/F)
PK parameters after administration of of TG103
Measured: Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study startApr 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenying Yang, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790006
- Sponsor's protocol ID
- SYSA1803-CSP-003
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 10 Mar 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 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter, Multiple Ascending Dose Phase Ib Study in Subjects With Type 2 Diabetes to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TG103 Injection
- ClinicalTrials.gov ID
- NCT04790006
- Acronym / sponsor ID
- SYSA1803-CSP-003
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 10 Mar 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 assess the safety and tolerability of multiple ascending doses of TG103 in subjects with type 2 diabetes.
Detailed description
This study is a randomized, double-blind, placebo-controlled, multicenter, dose-escalating study to characterize the safety (including the anti-drug antibodies(ADA)), tolerability pharmacokinetics (PK) and pharmacodynamic parameters（PD）of TG103. The study will consist of 3 periods: an approximately 2-week lead-in period, followed by a 12-week treatment period, and a 3-week safety follow-up period. Three dose groups (7.5mg, 15mg and 22.5mg) of subjects will be enrolled and dosed sequentially; 12
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TG103 | Experimental | Drug: TG103TG103 will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered via subcutaneous injection once weekly 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 (7 listed)
- 1. Subjects who fully understand the test content and possible adverse reactions and voluntarily participate in the trial and sign the informed consent form;
- 2.Age: 18 to 75 years of age inclusive; no gender limitation;
- 3. Weight：body mass index (BMI) within the range of 18.5-35 kg/m2 (inclusive), BMI = weight (kg) / height 2 (m2);
- 4. Patients have diagnosed with type 2 diabetes ≤ 3 years according to the World Health Organization (WHO1999) classification; and not on medication or without a history of regular medication for more than 1 week in the 3 months prior to screening (subjects with a history of medication only include those with a history of oral medication and a history of short-term intensive insulin therapy (≤ 2 weeks));
- 5. 7.0% ≤ HbA1c ≤ 10.0%;
Key exclusion criteria (25 listed)
- 1. Fasting plasma glucose ≥13.9mmol/L or a history of severe hypoglycemia (blood sugar below 2.2mmol/L);
- 2. Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg during screening;
- 3. During the screening period, the white blood cell count fall outside the reference range by 10%, or hemoglobin<100g / L;
- 4. Have one or more positive tests in Hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti- Treponema pallidum-specific antibody;
- 5. Aspartate aminotransferase(AST) or Alanine aminotransferase (ALT) > 2.5x upper limit of normal (ULN), or triglyceride > 5.7mmol/L or eGFR<60 mL/（min*1.73 m2）during the screening period;
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 |
|---|---|---|
| TG103Administered SC | Drug | TG103 |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Safety and tolerability assessed by incidence and severity of adverse events
Time frame: up to 15 weeks
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
7 secondary outcomes
Area under the plasma concentration versus time curve (AUC)
Time frame: Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78
glycosylated hemoglobin (HbA1c)
Time frame: Day15, 29, 43, 57,71, and 78,
The occurrence of TG103 anti-drug antibodies (ADA)
Time frame: up to 15 weeks
Peak Plasma Concentration (Cmax),
Time frame: Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78
Time to maximum plasma concentration (Tmax)
Time frame: Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78
Half time (t1/2),
Time frame: Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78
Apparent clearance (CL/F)
Time frame: Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 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.
Wenying Yang principal investigator
China-Japan Friendship Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TG103 in people with Type 2 Diabetes, run by CSPC ZhongQi Pharmaceutical Technology 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 7 inclusion and 25 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 10 Mar 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jiaoran Song (0311-69085931, songjiaoran@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability assessed by incidence and severity of adverse events (time frame: up to 15 weeks). 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 10 Mar 2021.