THDBH120 injection: Participants received THDBH120 by subcutaneous injection.
Placebo of THDBH120 injection: Participants received placebo by subcutaneous injection.
Study summary
To assess the efficacy and safety of THDBH120 injection compared with placebo in weight reduction in overweight or obese subjects after 26 weeks of treatment.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Male or female patients 18 to 75 years of age, inclusive;
* Have a BMI ≥ 28 kg/m² or 24 ≤BMI\< 28.0 kg/m² with at least 1 weight-related comorbidity at screening: prediabetes, hypertension, metabolic-associated fatty liver disease, dyslipidemia, weight-bearing joint pain, or obstructive sleep apnea syndrome;
* 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 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;
* A 12-lead electrocardiogram (ECG) shows any of the following at screening: heart rate \<50 bpm or \>100 bpm; QTcF prolongation (QT interval corrected by Fridericia's formula: QTc = QT/RR\^0.33; \>450 ms for males, \>470 ms for females); PR interval \>200 ms; presence of long QT syndrome; second- or third-degree atrioventricular block; left bundle branch block; complete right bundle branch block; Wolff-Parkinson-White syndrome; or any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the clinical trial.
Primary outcome measure(s)
Percentage change in body weight — Baseline, Week26
Trial sites (1)
Facility
City
Region
Status
The Second Xiangya Hospital of Central South University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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