THDBH120 injections for weight loss in adults with overweight or obesity

A Multicenter, Randomized, Double-blind, Placebo-Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of THDBH120 Injection in Overweight or Obese Subjects

This study will test whether THDBH120 injections help adults who are overweight or obese lose more weight than a placebo over 26 weeks.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 276 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd (Industry-sponsored)
• Locations: 1 site (Changsha)
• Trial ID: NCT07036601 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with BMI ≥28 kg/m² or BMI 24–28 kg/m² plus at least one weight-related comorbidity who have had stable diet and exercise for ≥3 months and do not have diabetes may be eligible.

Not a fit: People with a history of diabetes, obesity from endocrine or genetic causes, uncontrolled hypertension, or certain ECG abnormalities are excluded and may not benefit from participation.

Why it matters

Potential benefit: If successful, THDBH120 could become an additional medication option to help adults with overweight or obesity achieve meaningful weight loss.

How similar studies have performed: Other injectable weight-loss medications such as GLP-1 receptor agonists have shown substantial benefit, but THDBH120 is investigational and has limited published data so far.

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.

Where this trial is running

Changsha

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

Conditions Overweight or Obese