Overweight or Obese
Conditions
Brief 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.
Interventions
Participants received THDBH120 by subcutaneous injection.
Participants received placebo by subcutaneous injection.
Sponsors
Tonghua Dongbao Pharmaceutical Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in body weight | Baseline, Week26 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Achieve ≥10% Body Weight Reduction | Baseline, Week26 |
| Percentage of Participants Who Achieve ≥15% Body Weight Reduction | Baseline, Week26 |
| Percentage of Participants Who Achieve ≥20% Body Weight Reduction | Baseline, Week26 |
| Change from baseline in waist circumference after the treatment | Baseline, Week 26 |
| Percentage of Participants Who Achieve ≥5% Body Weight Reduction | Baseline, Week26 |
| Change from baseline in blood pressure after the treatment | Baseline, Week 26 |
| Change from baseline in HbA1c after the treatment | Baseline, Week 26 |
| Change from baseline in total cholesterol after the treatment | Baseline, Week 26 |
| Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s) | Week 30 |
| Change from baseline in BMI after the treatment | Baseline, Week 26 |
Countries
China
Outcome results
None listed