A Study of TG103 Injection in Overweight or Obesity

NCT ID: NCT05299697

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2023-09-30

Brief 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 further development.

Conditions

Overweight or Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TG103 15 mg

Administered subcutaneously (s.c., under the skin) once every week for 24 weeks. Doses gradually increased to 15 mg.

Group Type: EXPERIMENTAL

TG103 15 mg

Intervention Type: DRUG

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 mg

Administered subcutaneously (s.c., under the skin) once every week for 24 weeks. Doses gradually increased to 22.5 mg.

Group Type: EXPERIMENTAL

TG103 22.5 mg

Intervention Type: DRUG

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

Administered subcutaneously (s.c., under the skin) once every week for 24 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered subcutaneously (s.c., under the skin) as well as calorie restrict diet and increased physical activity for 24 weeks.

Interventions

TG103 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.

Intervention Type: DRUG

TG103 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.

Intervention Type: DRUG

Placebo

Administered subcutaneously (s.c., under the skin) as well as calorie restrict diet and increased physical activity for 24 weeks.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Li

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Locations

Baotou City Central Hospital

Baotou, Neimenggu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Li

Role: CONTACT

hfxyl@163.net

13719165213

Tianhao Zhang

Role: CONTACT

zhangtianhao@mail.ecspc.com

010-63932012

Facility Contacts

Tao Ning

Role: primary

Other Identifiers

SYSA1803-007

Identifier Type: -

Identifier Source: org_study_id