Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of THDBH120 in Chinese Patients With T2DM

NCT ID: NCT07020949

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-13
• Study Completion Date: 2024-11-27

Brief Summary

The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and efficacy of THDBH120 injection in participants with T2DM. This study includes three multiple-ascending dose cohorts.

Conditions

Diabetes Mellitus Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

THDBH120 injection

Group Type: EXPERIMENTAL

THDBH120 injection

Intervention Type: DRUG

Participants received THDBH120 by subcutaneous injection.

Placebo of THDBH120 injection

Group Type: PLACEBO_COMPARATOR

Placebo of THDBH120 injection

Intervention Type: DRUG

Participants received placebo by subcutaneous injection.

Interventions

THDBH120 injection

Participants received THDBH120 by subcutaneous injection.

Intervention Type: DRUG

Placebo of THDBH120 injection

Participants received placebo by subcutaneous injection.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female patients 18 to 75 years of age, inclusive;
• Have T2DM for at least 6 months before screening based on the disease diagnostic criteria (World Health Organization [WHO] Classification for Diabetes);
• Treated with diet and exercise alone, or a stable dose of metformin (≥1000 mg/day and not more than the locally approved dose) for at least 2 months prior to screening;
• Have a BMI between 23 and 35 kg/m²(inclusive) at screening;
• HbA1c levels: 7.0% to 10.0% (inclusive) for subjects treated by diet or exercise alone; 7.0% to 9.0% (inclusive) for subjects receiving stable-dose metformin.

Exclusion Criteria

• Have been diagnosed with proliferative diabetic retinopathy, diabetic maculopathy, or non-proliferative diabetic retinopathy requiring treatment during the study;
• Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia type 2;
• Have diagnosed hyperthyroidism or hypothyroidism;
• Have grade 2 hypoglycemia events or grade 3 hypoglycemia events within 6 months prior to screening;
• Have a history of ketoacidosis, lactic acidosis, or hyperosmolar state leading to hospitalization within 6 months prior to screening;
• 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);
• Weight change ≥ 5% within 3 months prior to screening;
• Have been treated with insulin, excluding insulin therapy for gestational diabetes mellitus, or acute/temporary insulin therapy (≤ 14 days) for conditions such as acute illness, hospitalization, or elective surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tonghua Dongbao Pharmaceutical Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University First Hospital

Beijing, , China

Countries

China

Other Identifiers

THDBH120L102

Identifier Type: -

Identifier Source: org_study_id