> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-ii-study-of-thdbh120-injection-in-overweight-or-obese-3e5e5f14-bcad-4cc1-b1d8-0e44ec95f5ae > Record changed: 2026-10-13 # Phase II Study of THDBH120 Injection in Overweight or Obese Subjects NCT07036601 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) Participants 276 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) Lead sponsor Tonghua Dongbao Pharmaceutical Co.,Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) Start date 2025-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **Short title** Phase II Study of THDBH120 Injection in Overweight or Obese Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) ## Dates **Completion date** 2026-03-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **First posted** 2025-06-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **Registry last updated** 2025-06-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **Primary completion date** 2026-02-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **Start date** 2025-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) ## Size and sites **Participants** 276 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **Planned participants** 276 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **Lead sponsor** Tonghua Dongbao Pharmaceutical Co.,Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) ## Identifiers **Registry ID** NCT07036601 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **ClinicalTrials.gov ID** NCT07036601 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) ## Outcomes ### Primary outcomes 1. Percentage change in body weight Timeframe: Baseline, Week26 ### Secondary outcomes 1. Percentage of Participants Who Achieve ≥5% Body Weight Reduction Timeframe: Baseline, Week26 2. Percentage of Participants Who Achieve ≥10% Body Weight Reduction Timeframe: Baseline, Week26 3. Percentage of Participants Who Achieve ≥15% Body Weight Reduction Timeframe: Baseline, Week26 4. Percentage of Participants Who Achieve ≥20% Body Weight Reduction Timeframe: Baseline, Week26 5. Change from baseline in waist circumference after the treatment Timeframe: Baseline, Week 26 6. Change from baseline in BMI after the treatment Timeframe: Baseline, Week 26 7. Change from baseline in blood pressure after the treatment Timeframe: Baseline, Week 26 8. Change from baseline in HbA1c after the treatment Timeframe: Baseline, Week 26 9. Change from baseline in total cholesterol after the treatment Timeframe: Baseline, Week 26 10. Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s) Timeframe: Week 30 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria - 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. ### Exclusion criteria - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) ## Sites - The Second Xiangya Hospital of Central South UniversityChangsha, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07036601) ## Related records ### Drugs (1) - [Inpegsomatropin](https://trialight.com/data/asset/inpegsomatropin-c32ce698-951f-4d34-8540-b95205257692.md) ### Lead sponsors (1) - [Tonghua Dongbao Pharmaceutical Co.,Ltd](https://trialight.com/data/company/tonghua-dongbao-pharmaceutical-co-ltd-d66ca72a-ebbf-4a69-9950-cada2701a997.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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