A Study of TG103 Injection in Overweight or Obesity

NCT05299697 | Unknown Phase 2

• 1 other identifier: SYSA1803-007
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Relative change from baseline in body weight at week 24

  percent change in body weight

  From baseline to week 24

Secondary Outcomes (18)

• Relative change from baseline in body weight (%) at week 12 and week 27

  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

  From baseline to week 24

• Change from baseline to 12 weeks, 24 weeks and 27 weeks in body weight

  From baseline to week 27

• Change from baseline to 12 weeks, 24 weeks and 27 weeks in BMI

  From baseline to week 27

• Change from baseline to 12 weeks, 24 weeks and 27 weeks in waist to hip circumference ratio

  From baseline to week 27

Other Outcomes (2)

• Ctrough (the trough plasma concentration of TG103)

  From baseline to week 24

• Number of participants with Anti-TG103 antibodies positive

  From baseline to week 27

Study Arms (3)

TG103 15 mg

EXPERIMENTAL

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

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.

Drug: TG103 22.5 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

TG103 15 mg 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 15 mg

TG103 22.5 mg 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.

TG103 22.5 mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Baotou City Central Hospital

Baotou, Neimenggu, 014040, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yan Li

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Li

CONTACT

13719165213; hfxyl@163.net

Tianhao Zhang

CONTACT

010-63932012; zhangtianhao@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 29, 2022
• Study Start: May 20, 2022
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)