Phase II Study of THDBH120 Injection in Overweight or Obese Subjects

NCT ID: NCT07036601

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2026-03-11

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.

Conditions

Overweight or Obese

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

THDBH120 injection

Group Type: EXPERIMENTAL

THDBH120 injection

Intervention Type: DRUG

Participants received THDBH120 by subcutaneous injection.

Placebo of THDBH120 injection

Group Type: PLACEBO_COMPARATOR

Placebo of THDBH120 injection

Intervention Type: DRUG

Participants received placebo by subcutaneous injection.

Interventions

THDBH120 injection

Participants received THDBH120 by subcutaneous injection.

Intervention Type: DRUG

Placebo of THDBH120 injection

Participants received placebo by subcutaneous injection.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tonghua Dongbao Pharmaceutical Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Xiangya Hospital of Central South University

Changsha, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zhiguang Zhou

Role: primary

zhouzg@hotmail.com

13873104348

Other Identifiers

THDBH120L202

Identifier Type: -

Identifier Source: org_study_id