A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of ZT002 Injection in Subjects With Overweight or Obesity
| Registry | NCT07020884 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 303 (Actual) |
| Sponsor | Beijing QL Biopharmaceutical Co.,Ltd (Industry) |
| Conditions | Overweight or Obesity |
| Interventions | ZT002 Injection, ZT002 Placebo (Drug) |
| Dates | start 2024-08-14, primary completion 2025-05-07, completion 2025-05-29, first posted 2025-06-13, last updated 2025-12-10 |
| Locations | 16 sites in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Overweight or Obesity All trials of ZT002 Injection All trials of ZT002 Placebo
This study will evaluate the percentage change from baseline in weight after 24 weeks of treatment with ZT002 Injection in subjects with overweight/obesity.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ZT002 Injection dose 1 | Experimental | Drug: ZT002 Injection | Dose 1 administered subcutaneously (SC), Q2W |
| ZT002 Injection dose 2 | Experimental | Drug: ZT002 Injection | Dose 2 administered subcutaneously (SC),Q2W |
| ZT002 Injection dose 3 | Experimental | Drug: ZT002 Injection | Dose 3 administered subcutaneously (SC),Q4W |
| ZT002 Injection dose 4 | Experimental | Drug: ZT002 Injection | Dose 4 administered subcutaneously (SC), Q4W |
| ZT002 Placebo | Placebo comparator | Drug: ZT002 Placebo | administered subcutaneously (SC), Q2W or Q4W |
Sex: All, ages: 18 Years to 75 Years
Inclusion Criteria: * Age ≥ 18 years and ≤ 75 years. * BMI ≥28 kg/m², or 24 kg/m2 ≤ BMI < 28 kg/m2 with at least one comorbidity (pre-diabetes, hypertension, hyperlipidemia, fatty liver, obstructive sleep apnoea syndrome due to overweight, weight-bearing joint pain, etc.) * Weight change is not more than 5% with diet and exercise control alone within 3 months prior to screening. Exclusion Criteria: * Previous diagnosis of diabetes; or HbA1c ≥ 6. 5% or fasting blood glucose ≥ 7.0 mmol/L at screening. * Have used medicines or treatments that affect weight within 3 months prior to screening. * History of acute or chronic pancreatitis. * Personal or family (parents, children, and siblings) history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type II (MEN2). * History of definite mental disease within 2 years prior to screening or prior suicidal tendency or suicidal behavir; or PHQ-9 scale score is ≥ 15 at screening; or C-SSRS questionnaire is either class 4 or 5 at screening.
| Facility | City | Country | Status |
|---|---|---|---|
| Handan First Hospital | Handan, Hebei | China | |
| Hebei Petro China Cental Hospital | Langfang, Hebei | China | |
| First Hospital of Qinhuangdao | Qinhuangdao, Hebei | China | |
| The Fourth Affiliated Hospital Harbin Medical University | Harbin, Heilongjiang | China | |
| The First Affiliated Hospital of Henan University of Science & Technology | Luoyang, Henan | China | |
| Luoyang Third People's Hospital | Luoyang, Henan | China | |
| The First Affiliated of Nanyang Medical College | Nanyang, Henan | China | |
| Nanjing Jiangning Hospital | Nanjing, Jiangsu | China | |
| Affiliated Hospital of Jiangsu University | Zhenjiang, Jiangsu | China | |
| Tonghua Central Hospital | Tonghua, Jilin | China | |
| Genertec Liaoyou Gem Flower Hospital | Panjin, Liaoning | China | |
| Central Hospital Affiliated to Shandong First Medical University | Jinan, Shandong | China | |
| Zibo Municipal Hospital | Zibo, Shandong | China | |
| Xi'an Daxing Hospital | Xi’an, Shanxi | China | |
| Peking University First Hospital | Beijing | China | |
| Peking University People's Hospital | Beijing | China |