Clinical Trials/NCT05063253

NCT05063253

Unknown

Phase 2

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy of TG103 Injection in Overweight/Obese Subjects With Type 2 Diabetes Mellitus

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.0 sites208 target enrollmentOctober 2021

ConditionsType 2 Diabetes Mellitus

InterventionsTG103 Placebo

DrugsTG103 Placebo

Overview

Phase: Phase 2
Intervention: TG103
Conditions: Type 2 Diabetes Mellitus
Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Enrollment: 208
Primary Endpoint: Changes in glycosylated hemoglobin (HbA1c) from baseline to week 20
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The main purpose of this study is to evaluate the efficacy, safety, PK and PD characteristics of different doses of TG103 injection in overweight/obese subjects with type 2 diabetes mellitus.

Detailed Description

This study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of TG103 injection in subjects with type 2 diabetes mellitus combined with overweight/obesity. The study will consist of 3 periods: an approximately 4-week screening period, a 20-week treatment period, and a 3-week safety follow-up period. Eligible subjects will be randomized in a 1:1:1:1 ratio into four paralleled dose groups (15 mg, 22.5 mg ,30 mg and placebo) with 52 subjects in each group. Within each group, subjects will receive TG103 injection or placebo subcutaneously (SC) once a week (QW) over a period of 20 weeks. Each group will be started at a low dose of 7.5 mg and gradually up-titrated at weekly intervals until the target dose.

Registry

clinicaltrials.gov

Start Date

October 2021

End Date

March 2024

Last Updated

4 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

•Subjects have diagnosed with type 2 diabetes according to the Guidelines for prevention and treatment of type 2 diabetes in China (2020 Edition);
•Aged 18 to 75 years (inclusive), no gender limitation;
•Body mass index (BMI) ≥ 24.0 kg/m\^2 with stable body weight (less than 5% self-reported change within 3 months);
•Subjects diagnosed with type 2 diabetes ≤ 3 years, and not on medication or with a history of regular medication for no more than 1 week within the 3 months prior to screening (subjects with a history of medication only include those with a history of single-agent oral medication and a history of short-term intensive insulin therapy (≤ 2 weeks)); 5.7.5% ≤ HbA1c ≤ 10.0%;
•6.Subjects of childbearing potential must use reliable methods of contraception from the date of signing an informed consent to at least 3 months after the last dose;
•The subject fully understand the trial and possible adverse reactions, has the ability to communicate properly with the investigator and comply with the research protocol; 8.Voluntarily participate in the trial and sign the informed consent form.

Exclusion Criteria

•Fasting plasma glucose ≥ 13.9 mmol/L at screening or a history of severe hypoglycemia (Serious event requiring help from others with changes in consciousness and/or body) within 6 months prior to screening;
•Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg during screening;
•Have one or more positive tests in anti-human immunodeficiency virus antibody or anti-treponema pallidum-specific antibody;
•Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≥2.5x upper limit of normal (ULN), or Total bilirubin (TBiL)≥1.5x ULN, or triglyceride \> 5.7 mmol/L or eGFR \< 60 mL/(min\*1.73 m\^2) during the screening period;
•Subjects with hematological diseases (e.g., aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or erythrocyte instability (e.g., malaria), or hemoglobin\<100 g/L;
•Hypercortisolism, polycystic ovary syndrome, abnormal thyroid function (those requiring medication or who have not reached a stable dose of treatment in 3 months prior to screening), etc. or other diseases that may affect blood glucose metabolism;
•Have a personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia, or other genetic diseases that are susceptible to medullary cancer, or calcitonin ≥ 50 ng/L(pg/mL);
•Acute complications of diabetes (including diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis) occurred once or more within 3 months or twice or more within 6 months before screening;
•Proliferative diabetic retinopathy, foot ulcers/gangrene, and manifestations of peripheral neuropathy with obvious symptoms (e.g., gastroparesis, urinary retention, intestinal obstruction, urinary incontinence, and painful peripheral neuropathy);
•Subjects with degree II or III atrioventricular block in 12-lead ECG (except for subjects who use the pacemaker), long QT syndrome or prolonged QTc interval (QTcF: \>450 ms for males, \>470 ms for females), or signs of clinically significant localised ischemic heart disease during the screening period; or those with other heart diseases that are judged by the investigator to be unsuitable for entry into the study;

Arms & Interventions

TG103, 15 mg

TG103 (15 mg) will be administered via subcutaneous injection once weekly.

Intervention: TG103

TG103, 22.5 mg

TG103 (22.5 mg) will be administered via subcutaneous injection once weekly.

Intervention: TG103

TG103, 30 mg

TG103 (30 mg) will be administered via subcutaneous injection once weekly.

Intervention: TG103

Placebo

Placebo will be administered via subcutaneous injection once weekly.

Intervention: Placebo

Outcomes

Primary Outcomes

Changes in glycosylated hemoglobin (HbA1c) from baseline to week 20

Time Frame: Baseline through Day 141 (the end of the 20-week treatment)

Secondary Outcomes

Change in blood lipid from baseline to week 20(Baseline through Day155 (the end of the follow-up))
Change in waist circumference from baseline to week 20(Baseline through Day155 (the end of the follow-up))
Change in waist-hip ratio from baseline to week 20(Baseline through Day155 (the end of the follow-up))
Change in 2-hour postprandial blood glucose from baseline to week 20(Baseline through Day 141 (the end of the 20-week treatment))
The occurrence of TG103 anti-drug antibodies (ADA) and neutralizing antibody (Nab).(Day1, 29, 57, 85, 113 and 155)
Change in blood pressure(systolic and diastolic blood pressure) from baseline to week 20(Baseline through Day155 (the end of the follow-up))
Incidence of adverse events(Baseline through Day155 (the end of the follow-up))
Change in body mass index (BMI) from baseline to week 20(Baseline through Day155 (the end of the follow-up))
Proportion of subjects with a baseline weight loss of more than 5%(Baseline through Day155 (the end of the follow-up))
Change in body weight from baseline to week 20(Baseline through Day155 (the end of the follow-up))
Change in fasting blood glucose from baseline to week 20(Baseline through Day 141 (the end of the 20-week treatment))
Minimum steady-state plasma drug concentration during a dosage interval (Cmin, SS)(Day1, 29, 57, 85 and 113)