Phase II Study of THDBH120 Injection in Overweight or Obese Subjects

NCT07036601 | Recruiting Phase 2

• 1 other identifier: THDBH120L202
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage change in body weight

  Baseline, Week26

Secondary Outcomes (10)

• 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

Study Arms (2)

THDBH120 injection

EXPERIMENTAL

Drug: THDBH120 injection

Placebo of THDBH120 injection

PLACEBO COMPARATOR

Drug: Placebo of THDBH120 injection

Interventions

THDBH120 injection DRUG

Participants received THDBH120 by subcutaneous injection.

THDBH120 injection

Placebo of THDBH120 injection DRUG

Participants received placebo by subcutaneous injection.

Placebo of THDBH120 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tonghua Dongbao Pharmaceutical Co.,Ltd: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: January 6, 2025
• Primary Completion: February 13, 2026
• Study Completion: March 11, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)