Overweight or ObesePhase 2NCT07036601
Phase II Study of THDBH120 Injection in Overweight or Obese Subjects
A Phase 2 study testing THDBH120 injection in people with Overweight or Obese, run by Tonghua Dongbao Pharmaceutical Co.,Ltd at 1 site in China.
Trial summary
To assess the efficacy and safety of THDBH120 injection compared with placebo in weight reduction in overweight or obese subjects after 26 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overweight or Obese
- 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
- 276 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2025to 11 Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 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 a BMI ≥ 28 kg/m² or 24 ≤BMI< 28.0 kg/m² with at least 1 weight-related comorbidity at screening: prediabetes, hypertension, metabolic-associated fatty liver disease, dyslipidemia, weight-bearing joint pain, or obstructive sleep apnea syndrome;
- Diet and exercise control for at least 3 months before screening visit, and less than 5% self-reported change within the last 3 months.
Who cannot join
- History 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;
- A 12-lead electrocardiogram (ECG) shows any of the following at screening: heart rate <50 bpm or >100 bpm; QTcF prolongation (QT interval corrected by Fridericia's formula: QTc = QT/RR^0.33; >450 ms for males, >470 ms for females); PR interval >200 ms; presence of long QT syndrome; second- or third-degree atrioventricular block; left bundle branch block; complete right bundle branch block; Wolff-Parkinson-White syndrome; or any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha
Zhiguang Zhou, 13873104348, zhouzg@hotmail.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of THDBH120 Injection in Overweight or Obese Subjects
To assess the efficacy and safety of THDBH120 injection compared with placebo in weight reduction in overweight or obese subjects after 26 weeks of treatment.
- Conditions
- Overweight or Obese
- Being tested
- THDBH120 injection, Placebo of THDBH120 injection
- Medical subject headings
- Overweight, Obesity
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.
Percentage change in body weight
Measured: Baseline, Week26
Secondary outcomes (10)
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Measured: Baseline, Week26
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Measured: Baseline, Week26
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Measured: Baseline, Week26
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
Measured: Baseline, Week26
Change from baseline in waist circumference after the treatment
Measured: Baseline, Week 26
Change from baseline in BMI after the treatment
Measured: Baseline, Week 26
Change from baseline in blood pressure after the treatment
Measured: Baseline, Week 26
Change from baseline in HbA1c after the treatment
Measured: Baseline, Week 26
Change from baseline in total cholesterol after the treatment
Measured: Baseline, Week 26
Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s)
Measured: Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start6 Jan 2025
- Primary completion13 Feb 2026 (estimated)
- Study completion11 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObeseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 276 participants (estimated)
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
- NCT07036601
- Sponsor's protocol ID
- THDBH120L202
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- Last updated
- 25 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of THDBH120 Injection in Overweight or Obese Subjects
- ClinicalTrials.gov ID
- NCT07036601
- Acronym / sponsor ID
- THDBH120L202
- Conditions
- Overweight or Obese
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Tonghua Dongbao Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 13 Feb 2026 (estimated)
- Study completion
- 11 Mar 2026 (estimated)
- First posted
- 25 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.
To assess the efficacy and safety of THDBH120 injection compared with placebo in weight reduction in overweight or obese subjects after 26 weeks of treatment.
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 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients 18 to 75 years of age, inclusive;
- Have a BMI ≥ 28 kg/m² or 24 ≤BMI< 28.0 kg/m² with at least 1 weight-related comorbidity at screening: prediabetes, hypertension, metabolic-associated fatty liver disease, dyslipidemia, weight-bearing joint pain, or obstructive sleep apnea syndrome;
- Diet and exercise control for at least 3 months before screening visit, and less than 5% self-reported change within the last 3 months.
Key exclusion criteria (4 listed)
- History 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;
- A 12-lead electrocardiogram (ECG) shows any of the following at screening: heart rate <50 bpm or >100 bpm; QTcF prolongation (QT interval corrected by Fridericia's formula: QTc = QT/RR^0.33; >450 ms for males, >470 ms for females); PR interval >200 ms; presence of long QT syndrome; second- or third-degree atrioventricular block; left bundle branch block; complete right bundle branch block; Wolff-Parkinson-White syndrome; or any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the clinical trial.
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
Percentage change in body weight
Time frame: Baseline, Week26
10 secondary outcomes
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Time frame: Baseline, Week26
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Time frame: Baseline, Week26
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Time frame: Baseline, Week26
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
Time frame: Baseline, Week26
Change from baseline in waist circumference after the treatment
Time frame: Baseline, Week 26
Change from baseline in BMI after the treatment
Time frame: Baseline, Week 26
Change from baseline in blood pressure after the treatment
Time frame: Baseline, Week 26
Change from baseline in HbA1c after the treatment
Time frame: Baseline, Week 26
Change from baseline in total cholesterol after the treatment
Time frame: Baseline, Week 26
Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s)
Time frame: Week 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Overweight or Obese
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 3
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
Obesity or Overweight
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing THDBH120 injection in people with Overweight or Obese, 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 25 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in body weight (time frame: Baseline, Week26). 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 25 Jun 2025.