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

Phase 1

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: THDBH120 injection; Drug: Placebo of THDBH120 injection

• Registration Number: NCT07020949
• 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 T2DM. This study includes three multiple-ascending dose cohorts.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-13
• Primary Completion: 2024-11-27
• Study Completion: 2024-11-27
• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

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
Number of Participants With Anti-THBHD120 Antibodies	78 days
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 HbA1C	43 days

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, China