Diabetes Mellitus Type 2Phase 1NCT07020949
Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of THDBH120 in Chinese Patients With T2DM
A Phase 1 study testing THDBH120 injection in people with Diabetes Mellitus Type 2, run by Tonghua Dongbao Pharmaceutical Co.,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- THDBH120 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2024to 27 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- THDBH120 injection, Placebo of THDBH120 injection
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THDBH120 injectionDrug
Participants received THDBH120 by subcutaneous injection.
Placebo of THDBH120 injectionDrug
Participants received placebo by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| THDBH120 injection | Experimental | Not described Receives: Drug: THDBH120 injection |
| Placebo of THDBH120 injection | Placebo comparator | Not described Receives: Drug: Placebo of THDBH120 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s)
Measured: 78 days
Secondary outcomes (4)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of THDBH120.
Measured: Day 1 Pre-dose through Day 43
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of THDBH120
Measured: Day 1 Pre-dose through Day 43
Change From Baseline in HbA1C
Measured: 43 days
Number of Participants With Anti-THBHD120 Antibodies
Measured: 78 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start13 Jun 2024
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tonghua Dongbao Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020949
- Sponsor's protocol ID
- THDBH120L102
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07020949
- Acronym / sponsor ID
- THDBH120L102
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Tonghua Dongbao Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THDBH120 injection | Experimental | Drug: THDBH120 injection |
| Placebo of THDBH120 injection | Placebo comparator | Drug: Placebo of THDBH120 injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THDBH120 injectionParticipants received THDBH120 by subcutaneous injection. | Drug | THDBH120 injection |
| Placebo of THDBH120 injectionParticipants received placebo by subcutaneous injection. | Drug | Placebo of THDBH120 injection |
Primary outcome
Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s)
Time frame: 78 days
4 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of THDBH120.
Time frame: Day 1 Pre-dose through Day 43
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of THDBH120
Time frame: Day 1 Pre-dose through Day 43
Change From Baseline in HbA1C
Time frame: 43 days
Number of Participants With Anti-THBHD120 Antibodies
Time frame: 78 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing THDBH120 injection in people with Diabetes Mellitus Type 2, run by Tonghua Dongbao Pharmaceutical Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s) (time frame: 78 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.