Status:
COMPLETED
Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of THDBH120 in Chinese Patients With Obesity
Lead Sponsor:
Tonghua Dongbao Pharmaceutical Co.,Ltd
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and efficacy of THDBH120 injection in participants with obesity. This study includes three multiple-ascending dose c...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years (inclusive), male or female;
- Body mass index (BMI) ≥ 28 kg/m²;
- Diet and exercise control for at least 3 months before screening visit, and less than 5% self-reported change within the last 3 months.
Exclusion
- Type 1 diabetes, type 2 diabetes, gestational diabetes, or other types of diabetes;
- History of obesity attributable to endocrine diseases, monogenic mutations, or drug-induced causes, such as hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, or hypogonadism; or weight gain resulting from increased non-fat mass (e.g., edema);
- Presence of uncontrolled hypertension at screening: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg;
- Prolonged QTcF interval on 12-lead ECG at screening (QTcF≥450 ms for males, \>470 ms for females), PR interval \>200 ms, or the presence of long QT syndrome, second- or third-degree atrioventricular block, left or right bundle branch block, Wolff-Parkinson-White syndrome, or any other clinically significant arrhythmias (except sinus arrhythmia).
Key Trial Info
Start Date :
July 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06951945
Start Date
July 18 2024
End Date
December 23 2024
Last Update
April 30 2025
Active Locations (2)
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1
The First Affiliated Hospital of Bengbu Medical University
Anhui, China
2
Hangzhou First People's Hospital
Zhejiang, China