A Study of TG103 Injection in Overweight/Obese Subjects Without Diabetes

NCT04855292 | Completed Phase 1

• 1 other identifier: SYSA1803-CSP-004
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to assess the safety and tolerability of multiple doses of TG103 injection in overweight/obese subjects without diabetes

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability assessed by incidence and severity of adverse events

  Up to 99 days

Secondary Outcomes (12)

• PK profile-AUC: Area under the plasma concentration versus time curve

  Day1, 8, 15, 22, 29, 64, 71, and 78

• PK profile- Cmax: Peak Plasma Concentration

  Day1, 8, 15, 22, 29, 64, 71, and 78

• PK profile- Tmax: Time to maximum plasma concentration

  Day1, 8, 15, 22, 29, 64, 71, and 78

• PK profile- t1/2: Half time

  Day1, 8, 15, 22, 29, 64, 71, and 78

• PK profile- CL/F: Apparent clearance

  Day1, 8, 15, 22, 29, 64, 71, and 78

Study Arms (3)

TG103 injection 15 mg

EXPERIMENTAL

TG103 injection (15 mg, N=12) and Placebo (N=4) will be administered subcutaneously once weekly in overweight/obese non-diabetic subjects.

Drug: TG103 injection; Drug: Placebo

TG103 injection 22.5 mg

EXPERIMENTAL

TG103 injection (22.5 mg, N=12) and Placebo (N=4) will be administered subcutaneously once weekly in overweight/obese non-diabetic subjects.

Drug: TG103 injection; Drug: Placebo

TG103 injection 30 mg

EXPERIMENTAL

TG103 injection (30 mg, N=12) and Placebo (N=4) will be administered subcutaneously once weekly in overweight/obese non-diabetic subjects.

Drug: TG103 injection; Drug: Placebo

Interventions

TG103 injection DRUG

TG103 injection, SC, once weekly

TG103 injection 15 mg; TG103 injection 22.5 mg; TG103 injection 30 mg

Placebo DRUG

Placebo control, SC, once weekly

TG103 injection 15 mg; TG103 injection 22.5 mg; TG103 injection 30 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years (inclusive); no gender limitation;
• Body mass index (BMI) ≥ 26.0 kg/m2, BMI = weight(kg)/height2 (m2); body weight ≥ 60 kg; Stable body weight (less than 5% self-reported change within 3 months);
• Fasting blood glucose 3.9-7.0 mmol/L (exclusive) and the HbA1c \< 6.5%;
• Subjects of childbearing age must use reliable methods of contraception from the date of signing an informed consent to at least 6 months after the last dose;
• Subjects who fully understand the study, voluntarily participate in the trial and sign the informed consent form。

You may not qualify if:

• History of allergy to Glucagon-like peptide-1 (GLP-1) analogues, or history of serious allergy to drugs or food;
• Secondary obesity, such as obesity induced by metabolic disease (e.g., Cushing's syndrome, hypothyroidism etc.) or drug treatment (e.g. with corticosteroids, tricyclic anti-depressants, atypical anti-psychotics);
• Subjects have confirmed diagnosis of type 1 or type 2 diabetes;
• History of or current pancreatitis (history of chronic or acute pancreatitis);
• Previous clinically significant abnormal gastric emptying (e.g., gastric outlet obstruction) and severe chronic gastrointestinal diseases (e.g., active ulcer within 6 months);
• Individual or family history of medullary thyroid cancer (MTC), type 2 multiple endocrine neoplasia syndrome or other hereditary diseases predisposing to MTC; abnormal and clinically significant thyroid function at screening, requiring pharmacological treatment or not yet clinically stable after treatment;
• Subjects with history of or current cholestasis or gallbladder stones (previous gallstone removal or lithotripsy) and/or cholecystectomy, who have no further sequelae, can enter into the study at the discretion of the investigator after assessing the risk;
• History of chronic malabsorption syndrome;
• Subjects with hematological diseases (e.g., aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or erythrocyte instability (e.g., malaria);
• Severe systemic infectious diseases within 1 month prior to screening;
• Systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg during screening;
• Any of the following serious cardiovascular and cerebrovascular events prior to screening: unstable angina pectoris requiring hospitalization, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention (except for diagnostic angiography), moderate to severe congestive heart failure (NYHA grade III or IV), atrial or ventricular arrhythmia requiring hospitalization (e.g., atrial fibrillation, ventricular tachycardia, tec.), second degree or third degree atrioventricular block without a pacemaker, clinically significant long QT syndrome or prolonged QTc interval, signs of localized ischemic heart disease, pacemaker or defibrillator implantation, stroke or transient ischemic attack or cerebrovascular accident within 6 months, or planned coronary artery bypass grafting or revascularization;
• The white blood cell count exceeds 10% of the normal range, or hemoglobin\<100 g/L during the screening period;
• Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≥ 2.5 x upper limit of normal (ULN), or fasting triglyceride ≥ 5.64 mmol/L or eGFR \< 60mL/(min\*1.73 m2) during the screening period;
• History of severe respiratory tract, blood system, central nervous system diseases (e.g., epilepsy, etc.), or history of malignant tumor, mental diseases (e.g., depression, anxiety, etc.), or history of other diseases that may endanger the safety of the subjects and are considered unsuitable for this study in the investigator's opinion;

Sponsors & Collaborators

• CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Gao Huanhuan

Beijingcun, Hebei, 050035, China

Location

Related Publications (1)

• Lin D, Xiao H, Yang K, Li J, Ye S, Liu Y, Jing S, Lin Y, Yang Y, Huang L, Yuan J, Li Z, Yang J, Gao H, Xie Y, Xu M, Yan L. Safety, tolerability, pharmacokinetics, and pharmacodynamics of TG103 injection in participants who are overweight or obese: a randomized, double-blind, placebo-controlled, multiple-dose phase 1b study. BMC Med. 2024 May 29;22(1):209. doi: 10.1186/s12916-024-03394-z.

  PMID: 38807146 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)