Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of THDBH120 in Chinese Patients With Obesity
NCT ID: NCT06951945
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2024-07-18
2024-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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THDBH120 injection
THDBH120 injection
Participants received THDBH120 by subcutaneous injection.
Placebo of THDBH120 injection
Placebo of THDBH120 injection
Participants received placebo by subcutaneous injection.
Interventions
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THDBH120 injection
Participants received THDBH120 by subcutaneous injection.
Placebo of THDBH120 injection
Participants received placebo by subcutaneous injection.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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).
18 Years
65 Years
ALL
No
Sponsors
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Tonghua Dongbao Pharmaceutical Co.,Ltd
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Bengbu Medical University
Anhui, , China
Hangzhou First People's Hospital
Zhejiang, , China
Countries
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Other Identifiers
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THDBH120L107
Identifier Type: -
Identifier Source: org_study_id