Overweight or ObesityPhase 2NCT05299697
A Study of TG103 Injection in Overweight or Obesity
A Phase 2 study testing TG103 15 mg and 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 II study to evaluate efficacy, safety, pharmacokinetics characteristics and immunogenicity of two dose levels of TG103 injection, a GLP-1 receptor agonist, in the management of overweight or obesity, to support dose selection for… 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 15 mg and 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
- 195 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2022to 30 Sep 2023
- 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
- 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. <5 kg self-reported change) within 12 weeks before screening as well as body weight ≥ 60 kg at screening.
- Weight loss less than 5% or weight increase after simple diet and exercise efforts for at least 3 months.
- 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
- Screening HbA1c ≥ 6.5%, or screening FPG ≥ 7.0mmol/L or<2.8mmol/L, or history of diabetes mellitus or hypoglycemia.
- Overweight or obesity due to single gene mutation, disease or drug, or weight increase due to non-fat mass increase.
- Treatment with any medication or product which in the investigator's opinion will cause change in weight to influence trial evaluations within 12 weeks before screening or during this study.
- Subjects who underwent bariatric surgery within 12 months before screening, or are not yet recovered from any surgery or injury at screening.
- Subjects who participated in any clinical trial and received the treatment within 12 weeks before screening, or who participated in the clinical trial and received treatment with TG103 injection.
- History of allergy or suspected allergy to GLP-1 receptor agonists or antibody agents, or other severe allergy history based on which the subjects may be allergic to the study drugs in investigator's opinion.
Show all 19Show fewer
- Personal history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2), or screening calcitonin ≥ 50 ng/L.
- Previous history or screening ultrasound includes one of the following: chronic pancreatitis, acute pancreatitis, gallstone with at least one of less than 5mm, choledocholithiasis, except that there was no cholelithiasis after treatment or cholecystectomy.
- No recovery from gastrointestinal disease or symptom at screening, or previous withdrawl of GLP-1 receptor agonist, GLP-1/GIP receptor agonist, GLP-1/GCG receptor agonist or metformin by gastrointestinal adverse drug reaction, or previous history of gastrointestinal surgery that influences the gastrointestinal motility in the investigators' opinions.
- Acute infection at screening.
- History of easily relapsed skin disease (e.g. urticaria), or present skin injury in any administration site at screening.
- History of acute coronary syndrome, stroke, severe asthma, epilepsy, systemic lupus erythematosus, hemolytic anemia, cirrhosis and the other severe disease, or history of malignant tumor.
- One of the followings at screening: systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg, or NYHA ≥ grade III, or QTc interval prolongation (i.e. QTcF>450ms in males or >470ms in females) or severe arrhythmia (e.g. atrioventricular block equal to or more than II degree, ventricular tachycardia).
- History of abnormal thyroid function with requirement of medication treatment at screening, or TSH beyond the normal reference range at screening.
- One of the followings at screening: 1) ALT or AST>3 × UNL (upper normal limit), or total bilirubin>1.5 × UNL, 2) blood amylase or lipase>1.5 × UNL, 3) TG>5.6mmol/L, 4) eGFR<60ml/min/1.73m^2 (calculated by CKD-EPI formula), 5) HBsAg, HCV-antibody, HIV-antibody or anti-TP antibody positive, 6) WBC< 3×10^9/L, or Hb <100g/L, 7) 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 male or female cannot use an effective contraceptive method during the trial and for 3 months after the end of treatment.
- Other situations that are not suitable for the study in the investigator's opinion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Baotou City Central Hospital
Baotou, Neimenggu, 014040
Tao Ning
Tao Ning
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study of TG103 Injection in the Management of Overweight or Obesity
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel phase II study to evaluate efficacy, safety, pharmacokinetics characteristics and immunogenicity of two dose levels of TG103 injection, a GLP-1 receptor agonist, in the management of overweight or obesity, to support dose selection for further development.
- Conditions
- Overweight or Obesity
- Being tested
- TG103 15 mg, 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 15 mgDrug
Administered subcutaneously (s.c., under the skin) as well as calorie restrict diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 15 mg.
TG103 22.5 mgDrug
Administered subcutaneously (s.c., under the skin) as well as calorie restrict diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg, 15 mg to 22.5 mg.
PlaceboDrug
Administered subcutaneously (s.c., under the skin) as well as calorie restrict diet and increased physical activity for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TG103 15 mg | Experimental | Administered subcutaneously (s.c., under the skin) once every week for 24 weeks. Doses gradually increased to 15 mg. Receives: Drug: TG103 15 mg |
| TG103 22.5 mg | Experimental | Administered subcutaneously (s.c., under the skin) once every week for 24 weeks. Doses gradually increased to 22.5 mg. Receives: Drug: TG103 22.5 mg |
| Placebo | Placebo comparator | Administered subcutaneously (s.c., under the skin) once every week for 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change from baseline in body weight at week 24
percent change in body weight
Measured: From baseline to week 24
Secondary outcomes (18)
Relative change from baseline in body weight (%) at week 12 and week 27
percent change in body weight
Measured: From baseline to week 27
Proportion of subjects with weight loss of ≥ 5% and ≥ 10% of baseline body weight at week 12 and week 24
Measured: From baseline to week 24
Change from baseline to 12 weeks, 24 weeks and 27 weeks in body weight
weight in kg
Measured: From baseline to week 27
Change from baseline to 12 weeks, 24 weeks and 27 weeks in BMI
BMI in kg/m^2
Measured: From baseline to week 27
Change from baseline to 12 weeks, 24 weeks and 27 weeks in waist to hip circumference ratio
waist circumference and hip circumference will be combined to report waist to hip circumference ratio
Measured: From baseline to week 27
Change from baseline to 12 weeks, 24 weeks and 27 weeks in waist circumference
waist circumference in cm
Measured: From baseline to week 27
Change from baseline to 12 weeks and 24 weeks in HbA1c
HbA1c in %
Measured: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in FPG (fasting plasma glucose)
FPG (fasting plasma glucose) in mmol/L
Measured: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in FINS (fasting insulin)
FINS (fasting insulin) in mU/L
Measured: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in fasting C peptide
fasting C peptide in nmol/L
Measured: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in HOMA-IR
FPG and FINS will be combined to report HOMA-IR in mmol/mU
Measured: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in TC（total cholesterol）
TC in mmol/L
Measured: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in TG（triglyceride）
TG in mmol/L
Measured: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in LDLC（low density lipoprotein cholesterol）
LDLC in mmol/L
Measured: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in HDLC（high density lipoprotein cholesterol）
HDLC in mmol/L
Measured: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in systolic blood pressure and diastolic blood pressure
systolic blood pressure, diastolic blood pressure in mmHg, respectively
Measured: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in scores of the patient health questionnaire (PHQ-9)
There are 9 items in PHQ-9 and the score ranges from 0-3 for each item. The total score will be the sum of the scores of all items.
Measured: From baseline to week 24
Number of TEAEs and SAEs from baseline to week 27
Measured: From baseline to week 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start20 May 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan Li, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299697
- Sponsor's protocol ID
- SYSA1803-007
- Status last verified
- May 2022
- First submitted
- 3 Mar 2022
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. 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 of TG103 Injection in the Management of Overweight or Obesity
- ClinicalTrials.gov ID
- NCT05299697
- Acronym / sponsor ID
- SYSA1803-007
- Conditions
- Overweight or Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 May 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 29 Mar 2022 (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 II study to evaluate efficacy, safety, pharmacokinetics characteristics and immunogenicity of two dose levels of TG103 injection, a GLP-1 receptor agonist, in the management of overweight or obesity, to support dose selection for further development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TG103 15 mg | Experimental | Drug: TG103 15 mgAdministered subcutaneously (s.c., under the skin) once every week for 24 weeks. Doses gradually increased to 15 mg. |
| TG103 22.5 mg | Experimental | Drug: TG103 22.5 mgAdministered subcutaneously (s.c., under the skin) once every week for 24 weeks. Doses gradually increased to 22.5 mg. |
| Placebo | Placebo comparator | Drug: PlaceboAdministered subcutaneously (s.c., under the skin) once every week for 24 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. <5 kg self-reported change) within 12 weeks before screening as well as body weight ≥ 60 kg at screening.
- Weight loss less than 5% or weight increase after simple diet and exercise efforts for at least 3 months.
- 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 (19 listed)
- Screening HbA1c ≥ 6.5%, or screening FPG ≥ 7.0mmol/L or<2.8mmol/L, or history of diabetes mellitus or hypoglycemia.
- Overweight or obesity due to single gene mutation, disease or drug, or weight increase due to non-fat mass increase.
- Treatment with any medication or product which in the investigator's opinion will cause change in weight to influence trial evaluations within 12 weeks before screening or during this study.
- Subjects who underwent bariatric surgery within 12 months before screening, or are not yet recovered from any surgery or injury at screening.
- Subjects who participated in any clinical trial and received the treatment within 12 weeks before screening, or who participated in the clinical trial and received treatment with TG103 injection.
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 15 mgAdministered subcutaneously (s.c., under the skin) as well as calorie restrict diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 15 mg. | Drug | TG103 15 mg |
| TG103 22.5 mgAdministered subcutaneously (s.c., under the skin) as well as calorie restrict diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg, 15 mg to 22.5 mg. | Drug | TG103 22.5 mg |
| PlaceboAdministered subcutaneously (s.c., under the skin) as well as calorie restrict diet and increased physical activity for 24 weeks. | Drug | Placebo |
Primary outcome
Relative change from baseline in body weight at week 24
Time frame: From baseline to week 24
percent change in body weight
18 secondary outcomes
Relative change from baseline in body weight (%) at week 12 and week 27
Time frame: From baseline to week 27
Proportion of subjects with weight loss of ≥ 5% and ≥ 10% of baseline body weight at week 12 and week 24
Time frame: From baseline to week 24
Change from baseline to 12 weeks, 24 weeks and 27 weeks in body weight
Time frame: From baseline to week 27
Change from baseline to 12 weeks, 24 weeks and 27 weeks in BMI
Time frame: From baseline to week 27
Change from baseline to 12 weeks, 24 weeks and 27 weeks in waist to hip circumference ratio
Time frame: From baseline to week 27
Change from baseline to 12 weeks, 24 weeks and 27 weeks in waist circumference
Time frame: From baseline to week 27
Change from baseline to 12 weeks and 24 weeks in HbA1c
Time frame: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in FPG (fasting plasma glucose)
Time frame: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in FINS (fasting insulin)
Time frame: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in fasting C peptide
Time frame: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in HOMA-IR
Time frame: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in TC（total cholesterol）
Time frame: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in TG（triglyceride）
Time frame: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in LDLC（low density lipoprotein cholesterol）
Time frame: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in HDLC（high density lipoprotein cholesterol）
Time frame: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in systolic blood pressure and diastolic blood pressure
Time frame: From baseline to week 24
Change from baseline to 12 weeks and 24 weeks in scores of the patient health questionnaire (PHQ-9)
Time frame: From baseline to week 24
Number of TEAEs and SAEs from baseline to week 27
Time frame: From baseline to week 27
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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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.
Yan Li 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 2 study testing TG103 15 mg and 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 19 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 23 May 2022. 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 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 Yan Li (13719165213, hfxyl@163.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change from baseline in body weight at week 24 (time frame: From baseline to week 24). 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 23 May 2022.