Obesity
Conditions
Brief summary
The main purpose of this study is to evaluate the safety and tolerability of continuing treatment with zovaglutide injection following titration to 2.4 mg semaglutide injection in adult participants with obesity.
Interventions
DRUGzovaglutide Arm 1
Zovaglutide will be administered via subcutaneous (SC) injection.
DRUGzovaglutide Arm 2
Zovaglutide will be administered via subcutaneous (SC) injection.
DRUGsemaglutide
Semaglutide will be administered via subcutaneous (SC) injection.
Sponsors
Beijing QL Biopharmaceutical Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking Description
Intervention model description
Model Description
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects aged≥18years and≤75 years at the time of signing the Informed Consent Form (ICF). * At screening, Body Mass Index (BMI)≥28kg/m² * Weight change due to diet and exercise alone within 3 months prior to screening did not exceed 5%.
Exclusion criteria
* Previously diagnosed obesity caused by monogenic mutations, other diseases, or medications. * Previous diagnosis of diabetes; or HbA1c ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L at screening. * Used of medicines or treatments that affect weight within 3 months prior to screening. * History of acute or chronic pancreatitis, or pancreatic injury. * History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history. * History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history. * Patient Health Questionnaire-9 (PHQ-9) scale score is ≥ 15 at screening * Screening Columbia-Suicide Severity Rating Scale(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 | Description |
|---|---|---|
| Proportion of participants achieving successful switch from semaglutide 2.4 mg to zovaglutide after randomization | from week 20 (randomization) to week 36 | Measure description:Definition of successful switch: Participants administered the target dose of assigned zovaglutide at both week28 and week32. |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving successful switch without severe gastrointestinal adverse event (GIAE) | from week 20 (randomization) to week 36 |
| Proportion of participants achieving successful switch without dose modification | from week 20 (randomization) to week 36 |
| Incidence of GIAE | from week 20 (randomization) to week 40 |
| Percentage of GIAE-free duration relative to total period after randomization | from week 20 (randomization) to week 40 |
| Changes in body weight from randomization | from week 20 （ randomization) to week 36 |
Countries
China
Contacts
CONTACTXiaoming Feng
CONTACTFengtai Xue
PRINCIPAL_INVESTIGATORLinong Ji, Doctor
Peking University People's Hospital
Outcome results
None listed