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

Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of THDBH120 in Chinese Patients With Obesity: A Randomized, Bouble-Blind, Placebo-Controlled Phase Ib Trial

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: THDBH120 injection; Drug: Placebo of THDBH120 injection

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui, China
    • The First Affiliated Hospital of Bengbu Medical University
  • Zhejiang, China
    • Hangzhou First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: THDBH120 injection	Drug: THDBH120 injection; Participants received THDBH120 by subcutaneous injection.
Placebo Comparator: Placebo of THDBH120 injection	Drug: Placebo of THDBH120 injection; Participants received placebo by subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2024
• Primary Completion (Actual): December 23, 2024
• Study Completion (Actual): December 23, 2024

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: THDBH120L107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No