Clinical trial NCT06226090: A Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity
Official title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Overweight
Lead sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-26
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized, double-blind, placebo-controlled, parallel phase 2 study to evaluate efficacy, safety, pharmacokinetic characteristics and immunogenicity of TG103 injection for weight management in non-diabetic patients with overweight in the presence of comorbidities or obesity, in addition to lifestyle intervention.


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 \&lt; 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 \&lt; 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.

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 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\&gt;5.6mmol/L, 6) eGFR\<60ml/min/1.73m\^2 , 7) positive of HBsAg, HCV-antibody, HIV-antibody or anti-TP antibody, 8) WBC\&lt; 3×10\^9/L, or Hb \&lt;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\&#39;s opinion.

Primary outcomes:
measure: Percentage relative change from baseline in body weight at week 24
timeFrame: From baseline to week 24
Secondary outcomes:
measure: Proportion of participants with weight loss of ≥ 5% at week 24
timeFrame: From baseline to week 24
measure: Proportion of participants with weight loss of ≥ 10% at week 24
timeFrame: From baseline to week 24
measure: Change from baseline to week 24 in waist circumference
timeFrame: From baseline to week 24
measure: Relative change from baseline in body weight at week 24
timeFrame: From baseline to week 24
measure: Change from baseline to week 24 in systolic blood pressure
timeFrame: From baseline to week 24
measure: Change from baseline to week 24 in diastolic blood pressure
timeFrame: From baseline to week 24
measure: Title: Change from baseline to week 24 in serum total cholesterol
timeFrame: From baseline to week 24
measure: Title: Change from baseline to week 24 in serum triglyceride
timeFrame: From baseline to week 24
measure: Title: Change from baseline to week 24 in serum low density lipoprotein cholesterol
timeFrame: From baseline to week 24
measure: Title: Change from baseline to week 24 in serum high density lipoprotein cholesterol
timeFrame: From baseline to week 24
Other outcomes:
measure: Number of TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events)
timeFrame: From baseline to week 27
measure: Change from baseline to week 24 in serum calcitonin
timeFrame: From baseline to week 24
measure: Change from baseline to week 24 in serum alanine transaminase
timeFrame: From baseline to week 24
measure: Change from baseline to week 24 in serum creatinine
timeFrame: From baseline to week 24
measure: Change from baseline to week 24 in serum HCG (Human Chorionic Gonadotophin)
timeFrame: From baseline to week 24
measure: Plasma concentration of TG103
timeFrame: From baseline to week 27
measure: Number of patients with positive TG103 antibody
timeFrame: From baseline to week 27
Locations:
city: Shijiazhuang
country: China
facility: Clinical Trials Information Group
state: Hebei
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Li Yan Study Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References: