Phase II Study of THDBH120 Injection in Overweight or Obese Subjects

Launched by TONGHUA DONGBAO PHARMACEUTICAL CO.,LTD · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new injection called THDBH120 to see if it can help people who are overweight or obese lose weight safely over 26 weeks. The study will compare the effects of this injection to a placebo, which is a harmless shot that doesn’t contain the active medicine, to understand if THDBH120 really works.

People between 18 and 75 years old who have a body mass index (BMI) of 28 or higher, or a BMI between 24 and 28 with at least one health issue related to weight—like prediabetes, high blood pressure, fatty liver, high cholesterol, joint pain, or sleep apnea—may be eligible to join. Participants should have tried dieting and exercising for at least three months before the study without much recent weight change. Those with certain health problems, such as diabetes, specific hormone-related causes of obesity, or serious heart issues, cannot take part. If you join, you can expect regular monitoring to check your health and how well the injection is working. This study is currently looking for volunteers who meet these criteria.

Gender

ALL

Eligibility 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.