Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of THDBH120 in Chinese Patients With Obesity

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: THDBH120 injection; Drug: Placebo of THDBH120 injection

• Registration Number: NCT06951945
• Lead Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd

Brief Summary

The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and efficacy of THDBH120 injection in participants with obesity. This study includes three multiple-ascending dose cohorts.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-18
• Primary Completion: 2024-12-23
• Study Completion: 2024-12-23
• Status Verified: 2025-04
• Study First Submitted: 2025-04-23
• Study First Submitted QC: 2025-04-23
• Last Update Submitted: 2025-04-23
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Age between 18 and 65 years (inclusive), male or female;
• Body mass index (BMI) ≥ 28 kg/m²;
• 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

• Type 1 diabetes, type 2 diabetes, gestational diabetes, or other types 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;
• Prolonged QTcF interval on 12-lead ECG at screening (QTcF≥450 ms for males, >470 ms for females), PR interval >200 ms, or the presence of long QT syndrome, second- or third-degree atrioventricular block, left or right bundle branch block, Wolff-Parkinson-White syndrome, or any other clinically significant arrhythmias (except sinus arrhythmia).

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
Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s)	78 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of THDBH120.	Day 1 Pre-dose through Day 43
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of THDBH120	Day 1 Pre-dose through Day 43
Change From Baseline in Body Weight	43 days
Number of Participants With Anti-THBHD120 Antibodies	78 days

Trial Locations

Locations (2)

The First Affiliated Hospital of Bengbu Medical University; 🇨🇳 Anhui, China

Hangzhou First People's Hospital; 🇨🇳 Zhejiang, China

The First Affiliated Hospital of Bengbu Medical University

🇨🇳Anhui, China