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Clinical Trial Details

Trial ID: L7296
Source ID: NCT05063253
Associated Drug: Tg103
Title: A Study of TG103 Injection in Overweight/Obese Subjects With Type 2 Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: TG103|DRUG: Placebo
Outcome Measures: Primary: Changes in glycosylated hemoglobin (HbA1c) from baseline to week 20, Baseline through Day 141 (the end of the 20-week treatment) | Secondary: Change in body weight from baseline to week 20, 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)|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 blood pressure(systolic and diastolic blood pressure) from baseline to week 20, Baseline through Day155 (the end of the follow-up)|Change in blood lipid 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)|Incidence of adverse events, Baseline through Day155 (the end of the follow-up)|Minimum steady-state plasma drug concentration during a dosage interval (Cmin, SS), Day1, 29, 57, 85 and 113|Change in fasting blood glucose from baseline to week 20, Baseline through Day 141 (the end of the 20-week treatment)|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
Sponsor/Collaborators: Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 208
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-10
Completion Date: 2024-03
Results First Posted:
Last Update Posted: 2021-10-01
Locations:
URL: https://clinicaltrials.gov/show/NCT05063253