- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05299697
A Study of TG103 Injection in Overweight or Obesity
May 20, 2022 updated by: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
195
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yan Li
- Phone Number: 13719165213
- Email: hfxyl@163.net
Study Contact Backup
- Name: Tianhao Zhang
- Phone Number: 010-63932012
- Email: zhangtianhao@mail.ecspc.com
Study Locations
-
-
Neimenggu
-
Baotou, Neimenggu, China, 014040
- Recruiting
- Baotou City Central Hospital
-
Contact:
- Tao Ning
-
Principal Investigator:
- Tao Ning
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TG103 15 mg
Administered subcutaneously (s.c., under the skin) once every week for 24 weeks.
Doses gradually increased to 15 mg.
|
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.
|
Experimental: TG103 22.5 mg
Administered subcutaneously (s.c., under the skin) once every week for 24 weeks.
Doses gradually increased to 22.5 mg.
|
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.
|
Placebo Comparator: Placebo
Administered subcutaneously (s.c., under the skin) once every week for 24 weeks.
|
Administered subcutaneously (s.c., under the skin) as well as calorie restrict diet and increased physical activity for 24 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative change from baseline in body weight at week 24
Time Frame: From baseline to week 24
|
percent change in body weight
|
From baseline to week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative change from baseline in body weight (%) at week 12 and week 27
Time Frame: From baseline to week 27
|
percent change in body weight
|
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
|
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
|
weight in kg
|
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
|
BMI in kg/m^2
|
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
|
waist circumference and hip circumference will be combined to report waist to hip circumference ratio
|
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
|
waist circumference in cm
|
From baseline to week 27
|
Change from baseline to 12 weeks and 24 weeks in HbA1c
Time Frame: From baseline to week 24
|
HbA1c in %
|
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
|
FPG (fasting plasma glucose) in mmol/L
|
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
|
FINS (fasting insulin) in mU/L
|
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
|
fasting C peptide in nmol/L
|
From baseline to week 24
|
Change from baseline to 12 weeks and 24 weeks in HOMA-IR
Time Frame: From baseline to week 24
|
FPG and FINS will be combined to report HOMA-IR in mmol/mU
|
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
|
TC in mmol/L
|
From baseline to week 24
|
Change from baseline to 12 weeks and 24 weeks in TG(triglyceride)
Time Frame: From baseline to week 24
|
TG in mmol/L
|
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
|
LDLC in mmol/L
|
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
|
HDLC in mmol/L
|
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
|
systolic blood pressure, diastolic blood pressure in mmHg, respectively
|
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
|
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.
|
From baseline to week 24
|
Number of TEAEs and SAEs from baseline to week 27
Time Frame: From baseline to week 27
|
From baseline to week 27
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ctrough (the trough plasma concentration of TG103)
Time Frame: From baseline to week 24
|
Ctrough will be measured once every 4 week until week 24.
|
From baseline to week 24
|
Number of participants with Anti-TG103 antibodies positive
Time Frame: From baseline to week 27
|
Anti-TG103 antibodies will be measured once every 4 week until week 27.
|
From baseline to week 27
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yan Li, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 20, 2022
Primary Completion (Anticipated)
June 30, 2023
Study Completion (Anticipated)
September 30, 2023
Study Registration Dates
First Submitted
March 3, 2022
First Submitted That Met QC Criteria
March 17, 2022
First Posted (Actual)
March 29, 2022
Study Record Updates
Last Update Posted (Actual)
May 23, 2022
Last Update Submitted That Met QC Criteria
May 20, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYSA1803-007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to share IPD.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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