- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05997576
A Study of TG103 Injection in Non-diabetic Overweight or Obesity
August 18, 2023 updated by: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
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).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
675
Phase
- Phase 3
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: officer Clinical Trials Information Group
- Phone Number: 86-0311-69085587
- Email: ctr-contact@cspc.cn
Study Locations
-
-
Hebei
-
Shijiazhuang, Hebei, China, 050011
- Clinical Trials Information Group
-
Contact:
- Clinical Trials Information Group officer
- Phone Number: 86-0311-69085587
- Email: ctr-contact@cspc.cn
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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., 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.
Exclusion Criteria:
- 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.
- 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.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TG103 22.5 mg
Administered subcutaneously once every week for 52 weeks.
Doses gradually increased to 22.5 mg.
|
Subcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks.
Doses gradually increased from 7.5 mg to 22.5 mg.
|
Placebo Comparator: Placebo
Administered subcutaneously once every week for 52 weeks.
|
Subcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From baseline to week 40
|
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.
|
From baseline to week 40
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants with weight loss of ≥ 5% at week 52
Time Frame: From baseline to week 52
|
Weight loss is percentage change at week 52 compared with baseline.
|
From baseline to week 52
|
Relative percentage change from baseline in body weight at week 52
Time Frame: From baseline to week 52
|
Weight loss is percentage change at week 52 compared with baseline.
|
From baseline to week 52
|
Proportion of participants with weight loss of ≥ 10%
Time Frame: From baseline to week 40, 52
|
Weight loss is percentage change at week 40 and week 52 compared with baseline.
|
From baseline to week 40, 52
|
Change from baseline in body weight (kg)
Time Frame: From baseline to week 40, 52
|
From baseline to week 40, 52
|
|
Change from baseline in waist circumference (cm)
Time Frame: From baseline to week 40, 52
|
From baseline to week 40, 52
|
|
Change from baseline in HbA1c (%)
Time Frame: From baseline to week 40, 52
|
From baseline to week 40, 52
|
|
Change from baseline in fasting plasma glucose (mmol/L)
Time Frame: From baseline to week 40, 52
|
From baseline to week 40, 52
|
|
Change from baseline in fasting insulin (mU/L)
Time Frame: From baseline to week 40, 52
|
From baseline to week 40, 52
|
|
Change from baseline in total cholesterol (mmol/L)
Time Frame: From baseline to week 40, 52
|
From baseline to week 40, 52
|
|
Change from baseline in triglyceride (mmol/L)
Time Frame: From baseline to week 40, 52
|
From baseline to week 40, 52
|
|
Change from baseline in low density lipoprotein cholesterol (mmol/L)
Time Frame: From baseline to week 40, 52
|
From baseline to week 40, 52
|
|
Change from baseline in high density lipoprotein cholesterol (mmol/L)
Time Frame: From baseline to week 40, 52
|
From baseline to week 40, 52
|
|
Change from baseline in systolic blood pressure (mmHg)
Time Frame: From baseline to week 40, 52
|
From baseline to week 40, 52
|
|
Change from baseline in diastolic blood pressure (mmHg)
Time Frame: From baseline to week 40, 52
|
From baseline to week 40, 52
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of TEAEs and SAEs assessed by CTCAE V5.0
Time Frame: From baseline to week 55
|
From baseline to week 55
|
|
Proportion of participants categorized by patient health questionnaire-9 (PHQ-9) score
Time Frame: From baseline to week 52
|
From baseline to week 52
|
|
Concentration of TG103 (Ctrough)
Time Frame: From baseline to week 55
|
From baseline to week 55
|
|
Proportion of anti-TG103-antibody-positive participants
Time Frame: From baseline to week 55
|
Plasma anti-TG103 antibody will be measured at baseline to establish a positive/negative cut-off point and during the study.
|
From baseline to week 55
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Li Yan, Sun Yat-sen Memorial Hospital,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 (Estimated)
September 1, 2023
Primary Completion (Estimated)
January 31, 2025
Study Completion (Estimated)
April 30, 2025
Study Registration Dates
First Submitted
August 8, 2023
First Submitted That Met QC Criteria
August 15, 2023
First Posted (Actual)
August 18, 2023
Study Record Updates
Last Update Posted (Actual)
August 21, 2023
Last Update Submitted That Met QC Criteria
August 18, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYSA1803-013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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