Phase II Study of THDBH120 Injection in Overweight or Obese Subjects

Phase 2

Recruiting

• Conditions: Overweight or Obese
• Interventions: Drug: THDBH120 injection; Drug: Placebo of THDBH120 injection

• Registration Number: NCT07036601
• Lead Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-06
• Status Verified: 2025-06
• Study First Submitted: 2025-06-16
• Study First Submitted QC: 2025-06-16
• Last Update Submitted: 2025-06-16
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Primary Completion: 2026-02-13
• Study Completion: 2026-03-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 276

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
THDBH120 injection	THDBH120 injection	-
Placebo of THDBH120 injection	Placebo of THDBH120 injection	-

Primary Outcome Measures

Name	Time	Method
Percentage change in body weight	Baseline, Week26

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieve ≥5% Body Weight Reduction	Baseline, Week26
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
Change from baseline in BMI after the treatment	Baseline, Week 26
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

Trial Locations

Locations (1)

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, China