Overweight or Obesity
Conditions
Brief 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.
Interventions
DRUGZT002 Injection
Administered SC
DRUGZT002 Placebo
Administered SC
Sponsors
Beijing QL Biopharmaceutical Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage change from baseline in weight after 24 weeks of treatment. | baseline, 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects with weight loss of ≥ 5%, ≥ 10%, and ≥ 15% from baseline after 24 weeks of treatment; | 24 weeks |
Countries
China
Outcome results
None listed