DiabetesPhase 1NCT04855292
A Study of TG103 Injection in Overweight/Obese Subjects Without Diabetes
A Phase 1 study testing TG103 injection in people with Diabetes, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The main purpose of this study is to assess the safety and tolerability of multiple doses of TG103 injection in overweight/obese subjects without diabetes Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- TG103 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 Jan 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years (inclusive); no gender limitation;
- Body mass index (BMI) ≥ 26.0 kg/m2, BMI = weight(kg)/height2 (m2); body weight ≥ 60 kg; Stable body weight (less than 5% self-reported change within 3 months);
- Fasting blood glucose 3.9-7.0 mmol/L (exclusive) and the HbA1c < 6.5%;
- Subjects of childbearing age must use reliable methods of contraception from the date of signing an informed consent to at least 6 months after the last dose;
- Subjects who fully understand the study, voluntarily participate in the trial and sign the informed consent form。
Who cannot join
- History of allergy to Glucagon-like peptide-1 (GLP-1) analogues, or history of serious allergy to drugs or food;
- Secondary obesity, such as obesity induced by metabolic disease (e.g., Cushing's syndrome, hypothyroidism etc.) or drug treatment (e.g. with corticosteroids, tricyclic anti-depressants, atypical anti-psychotics);
- Subjects have confirmed diagnosis of type 1 or type 2 diabetes;
- History of or current pancreatitis (history of chronic or acute pancreatitis);
- Previous clinically significant abnormal gastric emptying (e.g., gastric outlet obstruction) and severe chronic gastrointestinal diseases (e.g., active ulcer within 6 months);
- Individual or family history of medullary thyroid cancer (MTC), type 2 multiple endocrine neoplasia syndrome or other hereditary diseases predisposing to MTC; abnormal and clinically significant thyroid function at screening, requiring pharmacological treatment or not yet clinically stable after treatment;
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- Subjects with history of or current cholestasis or gallbladder stones (previous gallstone removal or lithotripsy) and/or cholecystectomy, who have no further sequelae, can enter into the study at the discretion of the investigator after assessing the risk;
- History of chronic malabsorption syndrome;
- Subjects with hematological diseases (e.g., aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or erythrocyte instability (e.g., malaria);
- Severe systemic infectious diseases within 1 month prior to screening;
- Systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg during screening;
- Any of the following serious cardiovascular and cerebrovascular events prior to screening: unstable angina pectoris requiring hospitalization, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention (except for diagnostic angiography), moderate to severe congestive heart failure (NYHA grade III or IV), atrial or ventricular arrhythmia requiring hospitalization (e.g., atrial fibrillation, ventricular tachycardia, tec.), second degree or third degree atrioventricular block without a pacemaker, clinically significant long QT syndrome or prolonged QTc interval, signs of localized ischemic heart disease, pacemaker or defibrillator implantation, stroke or transient ischemic attack or cerebrovascular accident within 6 months, or planned coronary artery bypass grafting or revascularization;
- The white blood cell count exceeds 10% of the normal range, or hemoglobin<100 g/L during the screening period;
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≥ 2.5 x upper limit of normal (ULN), or fasting triglyceride ≥ 5.64 mmol/L or eGFR < 60mL/(min*1.73 m2) during the screening period;
- History of severe respiratory tract, blood system, central nervous system diseases (e.g., epilepsy, etc.), or history of malignant tumor, 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;
- Use of approved weight-lowering pharmacotherapy (e.g., orlistat) within 3 months prior to the first dose;
- History of surgical treatment for obesity (except for liposuction performed one year ago);
- Have used incretin analogues or other drugs that might interfere with the trial in the opinion of the investigator within 3 months before the first dose;
- History of drug abuse or dependence within 5 years prior to screening, with a positive urine drugs of abuse testing at screening;
- Average alcohol intake is more than 21 units of alcohol (male)/14 units of alcohol (female) per week within the 3 months prior to screening, or positive alcohol breath test before administration;
- Smoke more than 5 cigarettes per day within 3 months prior to screening;
- Blood lost ≥ 400 mL due to trauma or major surgery or blood donation ≥ 400 mL within 3 months prior to screening;
- Have participated in any clinical trial involving an investigational product within 3 months prior to screening;
- Vaccinated within 28 days before screening or planned to be vaccinated within 1 week after receiving the study drug;
- Have a positive test result for hepatitis B surface antigen, hepatitis C antibody, anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody;
- Pregnant (blood pregnancy test positive at screening) and lactating female, or male and female planned to have children during the trial or within 6 months after the last dose;
- Not suitable for this study in the investigator's opinion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Dose Phase Ib Study in Overweight/Obese Subjects Without Diabetes to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of TG103 Injection
The main purpose of this study is to assess the safety and tolerability of multiple doses of TG103 injection in overweight/obese subjects without diabetes
Read the detailed description
This study is a randomized, double-blind, placebo-controlled, multiple-doses, parallel-group study to characterize the safety (including the anti-drug antibodies (ADA)), tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TG103 injection. The study will consist of 3 periods: an approximately 4-week screening period, followed by a 12-week treatment period, and a 3-week safety follow-up period. Eligible subjects will be enrolled into three paralleled dose groups (15 mg, 22.5 mg and 30 mg) with 16 subjects in each group. Within each group, subjects will be randomized in a 3:1 ratio to receive TG103 injection or placebo subcutaneously (SC) once a week (QW) over a period of 12 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
- Diabetes
- Being tested
- TG103 injection, Placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG103 injectionDrug
TG103 injection, SC, once weekly
PlaceboDrug
Placebo control, SC, once weekly
| Study group | Role | What they receive |
|---|---|---|
| TG103 injection 15 mg | Experimental | TG103 injection (15 mg, N=12) and Placebo (N=4) will be administered subcutaneously once weekly in overweight/obese non-diabetic subjects. Receives: Drug: TG103 injection; Drug: Placebo |
| TG103 injection 22.5 mg | Experimental | TG103 injection (22.5 mg, N=12) and Placebo (N=4) will be administered subcutaneously once weekly in overweight/obese non-diabetic subjects. Receives: Drug: TG103 injection; Drug: Placebo |
| TG103 injection 30 mg | Experimental | TG103 injection (30 mg, N=12) and Placebo (N=4) will be administered subcutaneously once weekly in overweight/obese non-diabetic subjects. Receives: Drug: TG103 injection; 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
Measured: Up to 99 days
Secondary outcomes (12)
PK profile-AUC: Area under the plasma concentration versus time curve
Measured: Day1, 8, 15, 22, 29, 64, 71, and 78
PK profile- Cmax: Peak Plasma Concentration
Measured: Day1, 8, 15, 22, 29, 64, 71, and 78
PK profile- Tmax: Time to maximum plasma concentration
Measured: Day1, 8, 15, 22, 29, 64, 71, and 78
PK profile- t1/2: Half time
Measured: Day1, 8, 15, 22, 29, 64, 71, and 78
PK profile- CL/F: Apparent clearance
Measured: Day1, 8, 15, 22, 29, 64, 71, and 78
PD profile- Weight change relative to baseline
Measured: Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85 and 99
PD profile- Proportion of subjects with a baseline weight loss of more than 5 percent
Measured: Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85 and 99
PD profile- Waistline change relative to baseline
Measured: Day8, 15, 22, 29, 43, 57, 71, 78, 85 and 99
PD profile- Change of waist-hip ratio relative to baseline
Measured: Day8, 15, 22, 29, 43, 57, 71, 78, 85 and 99
PD profile- Change of blood pressure（systolic blood pressure and diastolic blood pressure）relative to baseline
Measured: Day15, 22, 29, 43, 85 and 99
PD profile- Change of blood fat levels relative to baseline
Measured: Day15, 22, 29, 43, 85 and 99
The occurrence of TG103 anti-drug antibodies (ADA)
Measured: Day1, 15, 29, 57, and 99
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 Jul 2021
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 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
- NCT04855292
- Sponsor's protocol ID
- SYSA1803-CSP-004
- Status last verified
- Apr 2023
- First submitted
- 19 Apr 2021
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin D, Xiao H, Yang K, Li J, Ye S, Liu Y, Jing S, Lin Y, Yang Y, Huang L, Yuan J, Li Z, Yang J, Gao H, Xie Y, Xu M, Yan L. Safety, tolerability, pharmacokinetics, and pharmacodynamics of TG103 injection in participants who are overweight or obese: a randomized, double-blind, placebo-controlled, multiple-dose phase 1b study. BMC Med. 2024 May 29;22(1):209. doi: 10.1186/s12916-024-03394-z.
PubMed 38807146
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple Dose Phase Ib Study in Overweight/Obese Subjects Without Diabetes to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of TG103 Injection
- ClinicalTrials.gov ID
- NCT04855292
- Acronym / sponsor ID
- SYSA1803-CSP-004
- Conditions
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 22 Apr 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 doses of TG103 injection in overweight/obese subjects without diabetes
Detailed description
This study is a randomized, double-blind, placebo-controlled, multiple-doses, parallel-group study to characterize the safety (including the anti-drug antibodies (ADA)), tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TG103 injection. The study will consist of 3 periods: an approximately 4-week screening period, followed by a 12-week treatment period, and a 3-week safety follow-up period. Eligible subjects will be enrolled into three paralleled dose groups (15 mg, 22.5 mg and 30 mg) with 16 subjects in each group. Within each group, subjects will be randomized in a 3:1 ratio to receive TG103 injection or placebo subcutaneously (SC) once a week (QW) over a period of 12 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
- 3
| Arm | Type | Receives |
|---|---|---|
| TG103 injection 15 mg | Experimental | Drug: TG103 injection, Drug: PlaceboTG103 injection (15 mg, N=12) and Placebo (N=4) will be administered subcutaneously once weekly in overweight/obese non-diabetic subjects. |
| TG103 injection 22.5 mg | Experimental | Drug: TG103 injection, Drug: PlaceboTG103 injection (22.5 mg, N=12) and Placebo (N=4) will be administered subcutaneously once weekly in overweight/obese non-diabetic subjects. |
| TG103 injection 30 mg | Experimental | Drug: TG103 injection, Drug: PlaceboTG103 injection (30 mg, N=12) and Placebo (N=4) will be administered subcutaneously once weekly in overweight/obese non-diabetic subjects. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 75 years (inclusive); no gender limitation;
- Body mass index (BMI) ≥ 26.0 kg/m2, BMI = weight(kg)/height2 (m2); body weight ≥ 60 kg; Stable body weight (less than 5% self-reported change within 3 months);
- Fasting blood glucose 3.9-7.0 mmol/L (exclusive) and the HbA1c < 6.5%;
- Subjects of childbearing age must use reliable methods of contraception from the date of signing an informed consent to at least 6 months after the last dose;
- Subjects who fully understand the study, voluntarily participate in the trial and sign the informed consent form。
Key exclusion criteria (27 listed)
- History of allergy to Glucagon-like peptide-1 (GLP-1) analogues, or history of serious allergy to drugs or food;
- Secondary obesity, such as obesity induced by metabolic disease (e.g., Cushing's syndrome, hypothyroidism etc.) or drug treatment (e.g. with corticosteroids, tricyclic anti-depressants, atypical anti-psychotics);
- Subjects have confirmed diagnosis of type 1 or type 2 diabetes;
- History of or current pancreatitis (history of chronic or acute pancreatitis);
- Previous clinically significant abnormal gastric emptying (e.g., gastric outlet obstruction) and severe chronic gastrointestinal diseases (e.g., active ulcer within 6 months);
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 |
|---|---|---|
| TG103 injectionTG103 injection, SC, once weekly | Drug | TG103 injection 15 mg, TG103 injection 22.5 mg, TG103 injection 30 mg |
| PlaceboPlacebo control, SC, once weekly | Drug | TG103 injection 15 mg, TG103 injection 22.5 mg, TG103 injection 30 mg |
Primary outcome
Safety and tolerability assessed by incidence and severity of adverse events
Time frame: Up to 99 days
12 secondary outcomes
PK profile-AUC: Area under the plasma concentration versus time curve
Time frame: Day1, 8, 15, 22, 29, 64, 71, and 78
PK profile- Cmax: Peak Plasma Concentration
Time frame: Day1, 8, 15, 22, 29, 64, 71, and 78
PK profile- Tmax: Time to maximum plasma concentration
Time frame: Day1, 8, 15, 22, 29, 64, 71, and 78
PK profile- t1/2: Half time
Time frame: Day1, 8, 15, 22, 29, 64, 71, and 78
PK profile- CL/F: Apparent clearance
Time frame: Day1, 8, 15, 22, 29, 64, 71, and 78
PD profile- Weight change relative to baseline
Time frame: Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85 and 99
PD profile- Proportion of subjects with a baseline weight loss of more than 5 percent
Time frame: Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85 and 99
PD profile- Waistline change relative to baseline
Time frame: Day8, 15, 22, 29, 43, 57, 71, 78, 85 and 99
PD profile- Change of waist-hip ratio relative to baseline
Time frame: Day8, 15, 22, 29, 43, 57, 71, 78, 85 and 99
PD profile- Change of blood pressure（systolic blood pressure and diastolic blood pressure）relative to baseline
Time frame: Day15, 22, 29, 43, 85 and 99
PD profile- Change of blood fat levels relative to baseline
Time frame: Day15, 22, 29, 43, 85 and 99
The occurrence of TG103 anti-drug antibodies (ADA)
Time frame: Day1, 15, 29, 57, and 99
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 22 Jun 2023.
- Derived from this study: PubMed 38807146Lin D, Xiao H, Yang K, Li J, Ye S, Liu Y, Jing S, Lin Y, Yang Y, Huang L, Yuan J, Li Z, Yang J, Gao H, Xie Y, Xu M, Yan L. Safety, tolerability, pharmacokinetics, and pharmacodynamics of TG103 injection in participants who are overweight or obese: a randomized, double-blind, placebo-controlled, multiple-dose phase 1b study. BMC Med. 2024 May 29;22(1):209. doi: 10.1186/s12916-024-03394-z.
- 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.
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 1 study testing TG103 injection in people with Diabetes, 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 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: finished, as of the sponsor's last update on 22 Jun 2023. 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. 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?
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?
Safety and tolerability assessed by incidence and severity of adverse events (time frame: Up to 99 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04855292, which also lists 1 linked publication.
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 22 Jun 2023.