A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study of TG103 Injection in the Management of Overweight or Obesity

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.1 site in 1 country195 target enrollmentMay 20, 2022

ConditionsOverweight or Obesity

InterventionsTG103 15 mg TG103 22.5 mg Placebo

DrugsTG103 15 mg TG103 22.5 mg Placebo

Overview

Phase: Phase 2
Intervention: TG103 15 mg
Conditions: Overweight or Obesity
Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Enrollment: 195
Locations: 1
Primary Endpoint: Relative change from baseline in body weight at week 24
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 20, 2022

End Date

September 30, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Responsible Party

Sponsor

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.

Arms & Interventions

TG103 15 mg

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

Intervention: TG103 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.

Intervention: TG103 22.5 mg

Placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

Relative change from baseline in body weight at week 24

Time Frame: From baseline to week 24

percent change in body weight

Secondary Outcomes

Change from baseline to 12 weeks and 24 weeks in TG（triglyceride）(From baseline to week 24)
Change from baseline to 12 weeks and 24 weeks in HbA1c(From baseline to week 24)
Change from baseline to 12 weeks, 24 weeks and 27 weeks in BMI(From baseline to week 27)
Change from baseline to 12 weeks and 24 weeks in fasting C peptide(From baseline to week 24)
Change from baseline to 12 weeks and 24 weeks in HOMA-IR(From baseline to week 24)
Change from baseline to 12 weeks and 24 weeks in systolic blood pressure and diastolic blood pressure(From baseline to week 24)
Number of TEAEs and SAEs from baseline to week 27(From baseline to week 27)
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 waist circumference(From baseline to week 27)
Change from baseline to 12 weeks and 24 weeks in LDLC（low density lipoprotein cholesterol）(From baseline to week 24)
Change from baseline to 12 weeks and 24 weeks in scores of the patient health questionnaire (PHQ-9)(From baseline to week 24)
Change from baseline to 12 weeks, 24 weeks and 27 weeks in waist to hip circumference ratio(From baseline to week 27)
Change from baseline to 12 weeks and 24 weeks in FPG (fasting plasma glucose)(From baseline to week 24)
Change from baseline to 12 weeks and 24 weeks in FINS (fasting insulin)(From baseline to week 24)
Change from baseline to 12 weeks and 24 weeks in TC（total cholesterol）(From baseline to week 24)
Change from baseline to 12 weeks and 24 weeks in HDLC（high density lipoprotein cholesterol）(From baseline to week 24)