THDBH120 injections for weight loss in adults with overweight or obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II interventional trial compares THDBH120 injection with a matching placebo to measure weight reduction and safety over a 26-week treatment period. Eligible adults receive either THDBH120 or placebo injections and are monitored for changes in body weight and adverse events. Key enrollment criteria include ages 18–75 and a BMI ≥28 kg/m² or BMI 24–28 kg/m² with at least one weight-related comorbidity, with exclusions for diabetes and certain endocrine or cardiovascular conditions. The study is conducted at The Second Xiangya Hospital of Central South University in Changsha, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Xiangya Hospital of Central South University
  Changsha, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.