Overweight or ObesityPhase 3NCT05997576
A Study of TG103 Injection in Non-diabetic Overweight or Obesity
A Phase 3 study testing TG103 22.5 mg in people with Overweight or Obesity, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel phase 3 study to evaluate efficacy, safety, pharmacokinetics characteristics and immunogenicity of TG103 injection, a GLP-1 receptor agonist, for weight management in non-diabetic patients with BMI greater than or equal to 28 kg/m2 or… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- TG103 22.5 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 675 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2023to 3 Mar 2025
- 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
- Male or female, 18 years ≤ age ≤ 75 years.
- Body Mass Index (BMI) ≥ 28 kg/m^2, or 24 kg/m^2 < BMI ≤ 28 kg/m^2 with at least one of obesity-related complications.
- Regular diet and exercise and stable body weight (i.e., self-reported body weight change < 5%) within 12 weeks before screening as well as body weight ≥ 60 kg at screening.
- Weight loss less than 5% or no weight loss after diet and exercise intervention for at least 12 weeks.
- Be able to understand the trial and complete the procedures, and be voluntary to participate in this study and sign the informed consent.
Who cannot join
- History of type 2 diabetes, type 1 diabetes or hypoglycemia.
- Overweight or obesity due to disease or drug; or weight increase due to non-fat mass increase; or monogenic obesity.
- Medications or products which are judged by investigators to cause change in weight and influence trial evaluations have been used within 12 weeks before screening or will be used during study.
- Weight loss less than 5% by monotherapy or combination with GLP-1 receptor agonists for at least 12 weeks before screening.
- Bariatric surgery within 12 months before screening; or no full recovery from any surgery or injury at screening; or gastrointestinal motility dysfunction due to gastrointestinal surgery.
- Participation in any clinical trial to receive treatment within 12 weeks before screening, or participation in clinical trial to receive TG103 before screening.
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- History of allergy or suspected allergy to GLP-1 receptor agonists or antibody agents, or suspected allergy to TG103 judged by investigator due to other severe allergy history.
- Personal history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2).
- History or screening ultrasound reports of chronic pancreatitis, acute pancreatitis, etc.
- History of severe gastrointestinal disease; or gastrointestinal symptom at screening; or discontinuation of GLP-1 receptor agonist, GLP-1/GIP receptor agonist, GLP-1/GCG receptor agonist or metformin due to gastrointestinal adverse reaction.
- Severe infection at screening.
- Skin disorder that influences safety evaluation at screening.
- History of severe disease or malignant tumor.
- Systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg, NYHA Grade Ⅲ-Ⅳ, QTc interval prolongation or severe arrhythmia at screening.
- History of abnormal thyroid function with requirement of medication treatment at screening, or screening TSH beyond the normal reference range.
- One of the followings at screening: 1) HbA1c ≥ 6.5%, or screening FPG ≥ 7.0mmol/L or<2.8mmol/L; 2) calcitonin ≥ 50 ng/L; 3) ALT or AST>3 × UNL (upper normal limit), or total bilirubin>1.5 × UNL; 4) blood amylase or lipase>1.5 × UNL, 5) TG>5.6mmol/L, 6) eGFR<60ml/min/1.73m2 , 7) positive of HBsAg, HCV-antibody, HIV-antibody or anti-TP antibody, 8) WBC< 3×10^9/L, or Hb <100g/L, 9) INR>1.2.
- History of drug abuse, drug dependence or alcoholism.
- History of moderate to severe depression, or screening Patient Health Questionaire-9 (PHQ-9) score ≥ 15.
- The fertile female who is pregnant, breast-feeding or with blood HCG positive at screening; or the fertile participants and their partner cannot use an effective contraceptive method during the trial and within 3 months after the end of treatment.
- Other situations unsuitable for this study in the investigator's opinion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel phase 3 study to evaluate efficacy, safety, pharmacokinetics characteristics and immunogenicity of TG103 injection, a GLP-1 receptor agonist, for weight management in non-diabetic patients with BMI greater than or equal to 28 kg/m2 or greater than 24 kg/m2 in the presence of comorbidities, in addition to lifestyle intervention (calorie restrict diet and increased physical activity).
- Conditions
- Overweight or Obesity
- Being tested
- TG103 22.5 mg, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG103 22.5 mgDrug
Subcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks. Doses gradually increased from 7.5 mg to 22.5 mg.
PlaceboDrug
Subcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TG103 22.5 mg | Experimental | Administered subcutaneously once every week for 52 weeks. Doses gradually increased to 22.5 mg. Receives: Drug: TG103 22.5 mg |
| Placebo | Placebo comparator | Administered subcutaneously once every week for 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with weight loss of ≥ 5% at week 40
Weight loss is percentage change at week 40 compared with baseline.
Measured: From baseline to week 40
Relative percentage change from baseline in body weight at week 40
Weight loss is percentage change at week 40 compared with baseline.
Measured: From baseline to week 40
Secondary outcomes (14)
Proportion of participants with weight loss of ≥ 5% at week 52
Weight loss is percentage change at week 52 compared with baseline.
Measured: From baseline to week 52
Relative percentage change from baseline in body weight at week 52
Weight loss is percentage change at week 52 compared with baseline.
Measured: From baseline to week 52
Proportion of participants with weight loss of ≥ 10%
Weight loss is percentage change at week 40 and week 52 compared with baseline.
Measured: From baseline to week 40, 52
Change from baseline in body weight (kg)
Measured: From baseline to week 40, 52
Change from baseline in waist circumference (cm)
Measured: From baseline to week 40, 52
Change from baseline in HbA1c (%)
Measured: From baseline to week 40, 52
Change from baseline in fasting plasma glucose (mmol/L)
Measured: From baseline to week 40, 52
Change from baseline in fasting insulin (mU/L)
Measured: From baseline to week 40, 52
Change from baseline in total cholesterol (mmol/L)
Measured: From baseline to week 40, 52
Change from baseline in triglyceride (mmol/L)
Measured: From baseline to week 40, 52
Change from baseline in low density lipoprotein cholesterol (mmol/L)
Measured: From baseline to week 40, 52
Change from baseline in high density lipoprotein cholesterol (mmol/L)
Measured: From baseline to week 40, 52
Change from baseline in systolic blood pressure (mmHg)
Measured: From baseline to week 40, 52
Change from baseline in diastolic blood pressure (mmHg)
Measured: From baseline to week 40, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start22 Nov 2023
- Primary completion17 Feb 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Yan, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997576
- Sponsor's protocol ID
- SYSA1803-013
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2023
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity
- ClinicalTrials.gov ID
- NCT05997576
- Acronym / sponsor ID
- SYSA1803-013
- Conditions
- Overweight or Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 675 participants (actual)
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 18 Aug 2023 (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 study is a multicenter, randomized, double-blind, placebo-controlled, parallel phase 3 study to evaluate efficacy, safety, pharmacokinetics characteristics and immunogenicity of TG103 injection, a GLP-1 receptor agonist, for weight management in non-diabetic patients with BMI greater than or equal to 28 kg/m2 or greater than 24 kg/m2 in the presence of comorbidities, in addition to lifestyle intervention (calorie restrict diet and increased physical activity).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TG103 22.5 mg | Experimental | Drug: TG103 22.5 mgAdministered subcutaneously once every week for 52 weeks. Doses gradually increased to 22.5 mg. |
| Placebo | Placebo comparator | Drug: PlaceboAdministered subcutaneously once every week for 52 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, 18 years ≤ age ≤ 75 years.
- Body Mass Index (BMI) ≥ 28 kg/m^2, or 24 kg/m^2 < BMI ≤ 28 kg/m^2 with at least one of obesity-related complications.
- Regular diet and exercise and stable body weight (i.e., self-reported body weight change < 5%) within 12 weeks before screening as well as body weight ≥ 60 kg at screening.
- Weight loss less than 5% or no weight loss after diet and exercise intervention for at least 12 weeks.
- Be able to understand the trial and complete the procedures, and be voluntary to participate in this study and sign the informed consent.
Key exclusion criteria (20 listed)
- History of type 2 diabetes, type 1 diabetes or hypoglycemia.
- Overweight or obesity due to disease or drug; or weight increase due to non-fat mass increase; or monogenic obesity.
- Medications or products which are judged by investigators to cause change in weight and influence trial evaluations have been used within 12 weeks before screening or will be used during study.
- Weight loss less than 5% by monotherapy or combination with GLP-1 receptor agonists for at least 12 weeks before screening.
- Bariatric surgery within 12 months before screening; or no full recovery from any surgery or injury at screening; or gastrointestinal motility dysfunction due to gastrointestinal surgery.
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 22.5 mgSubcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks. Doses gradually increased from 7.5 mg to 22.5 mg. | Drug | TG103 22.5 mg |
| PlaceboSubcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks. | Drug | Placebo |
Primary outcome
Proportion of participants with weight loss of ≥ 5% at week 40
Time frame: From baseline to week 40
Weight loss is percentage change at week 40 compared with baseline.
Relative percentage change from baseline in body weight at week 40
Time frame: From baseline to week 40
Weight loss is percentage change at week 40 compared with baseline.
14 secondary outcomes
Proportion of participants with weight loss of ≥ 5% at week 52
Time frame: From baseline to week 52
Relative percentage change from baseline in body weight at week 52
Time frame: From baseline to week 52
Proportion of participants with weight loss of ≥ 10%
Time frame: From baseline to week 40, 52
Change from baseline in body weight (kg)
Time frame: From baseline to week 40, 52
Change from baseline in waist circumference (cm)
Time frame: From baseline to week 40, 52
Change from baseline in HbA1c (%)
Time frame: From baseline to week 40, 52
Change from baseline in fasting plasma glucose (mmol/L)
Time frame: From baseline to week 40, 52
Change from baseline in fasting insulin (mU/L)
Time frame: From baseline to week 40, 52
Change from baseline in total cholesterol (mmol/L)
Time frame: From baseline to week 40, 52
Change from baseline in triglyceride (mmol/L)
Time frame: From baseline to week 40, 52
Change from baseline in low density lipoprotein cholesterol (mmol/L)
Time frame: From baseline to week 40, 52
Change from baseline in high density lipoprotein cholesterol (mmol/L)
Time frame: From baseline to week 40, 52
Change from baseline in systolic blood pressure (mmHg)
Time frame: From baseline to week 40, 52
Change from baseline in diastolic blood pressure (mmHg)
Time frame: From baseline to week 40, 52
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 11 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Li Yan principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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 22.5 mg in people with Overweight or Obesity, 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 20 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 11 Aug 2025. 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?
Proportion of participants with weight loss of ≥ 5% at week 40 (time frame: From baseline to week 40). The study lists 2 primary outcomes in all. 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 11 Aug 2025.