Clinical trial NCT07020949: Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of THDBH120 in Chinese Patients With T2DM
Official title: Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of THDBH120 in Chinese Patients With T2DM: A Randomized, Bouble-Blind, Placebo-Controlled Phase Ib Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2025-06-13
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s)
timeFrame: 78 days
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of THDBH120.
timeFrame: Day 1 Pre-dose through Day 43
measure: Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of THDBH120
timeFrame: Day 1 Pre-dose through Day 43
measure: Change From Baseline in HbA1C
timeFrame: 43 days
measure: Number of Participants With Anti-THBHD120 Antibodies
timeFrame: 78 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
References: