Overweight , Obesity
Conditions
Brief summary
This study will evaluate the percentage change in body weight from baseline and proportion of subjects achieving ≥ 5% weight loss from baseline after 52 weeks of treatment with Zovaglutide in subjects with overweight/obesity.
Interventions
DRUGZovaglutide dose 1
administered subcutaneously (SC), Q4W
DRUGZovaglutide dose 2
administered subcutaneously (SC), Q4W
DRUGPlacebo
administered subcutaneously (SC), Q4W
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
* 1\. Male or female subjects aged≥18years and≤75 years at the time of signing the ICF. * 2.At screening and prior to randomization, BMI must meet one of the following criteria: 1. BMI≥28kg/m²regardless of comorbidities； 2. BM≤24 kg/m² and\<28 kg/m², with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, fatty liver disease, obstructive sleep apnea syndrome due to overweight, or weight-bearing joint pain. * 3.Weight change due to diet and exercise alone within 3 months prior to screening and randomization did not exceed 5%.
Exclusion criteria
* 1.Previously diagnosed obesity caused by monogenic mutations, other diseases, or medications. * 2.Previous diagnosis of diabetes; or HbA1c ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L at screening. * 3.Used of medicines or treatments that affect weight within 3 months prior to screening. * 4.History of acute or chronic pancreatitis, or pancreatic injury. * 5.History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history. * 6.History of depression/anxiety disorder, or prior diagnosis of moderate-to-severe anxiety/depressive state, or history of severe psychiatric disorders; * 7\. PHQ-9 scale score is ≥ 15 at screening; * 8\. Screening C-SSRS questionnaire suicide ideation response of "Category 4 or 5," or any "yes" response to suicidal behavior questions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight(%) | baseline (week 0) to week 52 |
| Proportion of subjects achieving ≥ 5% weight loss | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving ≥10% weight loss | week 52 |
| Proportion of subjects achieving ≥15% weight loss. | week 52 |
| Proportion of subjects achieving ≥20% weight loss. | week 52 |
| Change in body weight (kg) | Baseline (week 0) to week 52 |
| Change in BMI (kg/m²) | Baseline (week 0) to week 52 |
| Change in waist circumference (cm) | Baseline (week 0) to week 52 |
| Change in hip circumference (cm) | Baseline (week 0) to week 52 |
| Number of Treatment Emergent Adverse Events (TEAEs) | Baseline (week 0) to week 56 |
| Number of Serious Adverse Events (SAEs) | Baseline (week 0) to week 56 |
| Positive rate of anti-drug antibodies (ADA). | Baseline (week 0) to week 56 |
| Positive rate of neutralizing antibodies (Nab) | Baseline (week 0) to week 56 |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORLinong Ji, MD
Peking University People's Hospital
Outcome results
None listed