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

NCT06951945 | Completed Phase 1

• 1 other identifier: THDBH120L107
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

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

  78 days

Secondary Outcomes (4)

• 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

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tonghua Dongbao Pharmaceutical Co.,Ltd: lead

Study Sites (2)

The First Affiliated Hospital of Bengbu Medical University

Anhui, China

Location

Hangzhou First People's Hospital

Zhejiang, China

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: July 18, 2024
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)