Clinical trial
Phase II Study of THDBH120 Injection in Overweight or Obese Subjects
Recruiting now · Phase 2 · 1 countries · Registry ID NCT07036601
Recruiting nowPhase 2Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionOverweight or Obese
Full registry criteria
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.
Treatments and study arms
THDBH120 injection
Drug
Participants received THDBH120 by subcutaneous injection.
Placebo of THDBH120 injection
Drug
Participants received placebo by subcutaneous injection.
Primary outcomes
Percentage change in body weightBaseline, Week26
Study locations
1 locations were listed when this page was built. The first 40 are shown.
The Second Xiangya Hospital of Central South University🇨🇳 Changsha, China
Zhiguang ZhouContact