Obesity and overweight
Conditions
Interventions
Observation group:N/A
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Participants who completed the safety follow-up of the multicenter, randomized, double-blind, placebo-controlled phase ?b clinical trial (YN011-W202) of the efficacy and safety of injectable ixupaglutide a in overweight and obese subjects; 2) Subjects with a weight loss of >=5% at the primary endpoint of the phase IIb clinical trial; 3) Subjects who agree not to use weight loss drugs or treatments during this study; 4) Subjects who are willing to sign a written informed consent form and comply with the study protocol;
Exclusion criteria
Exclusion criteria: 1.The investigator deems that the subject has a disease state that may prevent the completion of the follow-up during the observation period. 2.The investigator determines that there are situations affecting the compliance of this study for the subject during the treatment with Efsubaglutide Alfa.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage change in body weight of the subjects 24 weeks after drug withdrawal (i.e., 4-week safety follow-up in phase IIB study + 20-week follow-up after the end of phase IIB study) compared with that before drug withdrawal.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes in body weight, body fat, waist circumference, HbA1c, FPG, fasting insulin, liver and kidney functions and blood lipids of the subjects 24 weeks after drug withdrawal compared with those before drug withdrawal; | — |
Countries
China
Contacts
Public ContactJia Weiping
600 Yishan Road, Xuhui District, Shanghai
Outcome results
None listed