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Recruiting NCT07036601

Phase II Study of THDBH120 Injection in Overweight or Obese Subjects

Phase II Interventional Overweight or Obese

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: THDBH120 injection, Placebo of THDBH120 injection.
Who it may be relevant to
Registry conditions: Overweight or Obese. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug THDBH120 injection
    Participants received THDBH120 by subcutaneous injection.
  • Drug Placebo of THDBH120 injection
    Participants received placebo by subcutaneous injection.

Primary outcome measures

  • Percentage change in body weight [Time frame: Baseline, Week26]
Secondary outcome measures (10)
  • Percentage of Participants Who Achieve ≥5% Body Weight Reduction [Time frame: Baseline, Week26]
  • Percentage of Participants Who Achieve ≥10% Body Weight Reduction [Time frame: Baseline, Week26]
  • Percentage of Participants Who Achieve ≥15% Body Weight Reduction [Time frame: Baseline, Week26]
  • Percentage of Participants Who Achieve ≥20% Body Weight Reduction [Time frame: Baseline, Week26]
  • Change from baseline in waist circumference after the treatment [Time frame: Baseline, Week 26]
  • Change from baseline in BMI after the treatment [Time frame: Baseline, Week 26]
  • Change from baseline in blood pressure after the treatment [Time frame: Baseline, Week 26]
  • Change from baseline in HbA1c after the treatment [Time frame: Baseline, Week 26]
  • Change from baseline in total cholesterol after the treatment [Time frame: Baseline, Week 26]
  • Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s) [Time frame: Week 30]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Xiangya Hospital of Central South University — Changsha

Identifiers

NCT: NCT07036601 · THDBH120L202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗