A Study of ZT002 Injection With Subjects With Overweight or Obesity
NCT07020884
Phase
Phase 2
Recruitment status
Completed
Participants
Lead sponsor
Beijing QL Biopharmaceutical Co.,Ltd
Start date
2024-08-14
Number of sites
- Summary
- This study will evaluate the percentage change from baseline in weight after 24 weeks of treatment with ZT002 Injection in subjects with overweight/obesity.
- Short title
- A Study of ZT002 Injection With Subjects With Overweight or Obesity
- Official title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2025-05-29
- First posted
- 2025-06-13
- Registry last updated
- 2025-12-10
- Primary completion date
- 2025-05-07
- Start date
- 2024-08-14
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07020884
- ClinicalTrials.gov ID
- NCT07020884
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Sources for study design
The percentage change from baseline in weight after 24 weeks of treatment.
Timeframe: baseline, 24 weeks
The proportion of subjects with weight loss of ≥ 5%, ≥ 10%, and ≥ 15% from baseline after 24 weeks of treatment;
Timeframe: 24 weeks
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- 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.
Sources for eligibility
- Handan First HospitalHandan, China
- Hebei Petro China Cental HospitalLangfang, China
- First Hospital of QinhuangdaoQinhuangdao, China
- The Fourth Affiliated Hospital Harbin Medical UniversityHarbin, China
- The First Affiliated Hospital of Henan University of Science & TechnologyLuoyang, China
- Luoyang Third People's HospitalLuoyang, China
- The First Affiliated of Nanyang Medical CollegeNanyang, China
- Nanjing Jiangning HospitalNanjing, China
- Affiliated Hospital of Jiangsu UniversityZhenjiang, China
- Tonghua Central HospitalTonghua, China
- Genertec Liaoyou Gem Flower HospitalPanjin, China
- Central Hospital Affiliated to Shandong First Medical UniversityJinan, China
- Zibo Municipal HospitalZibo, China
- Xi'an Daxing HospitalXi’an, China
- Peking University First HospitalBeijing, China
- Peking University People's HospitalBeijing, China
Sources for sites