Overweight or Obesity
Conditions
Interventions
Group B:After receiving 12 weeks of liraglutide injections combined with 5:2 intermittent fasting, then receive 12 weeks of conventional lifestyle education.
Group A:After undergoing 12 weeks of standard lifestyle education, receive 12 weeks of liraglutide injection combined with 5:2 intermittent fasting treatment.
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-75 years old (inclusive), open to all genders; 2.Participants who have been on a stable treatment with a weekly formulation of a weight loss medication (such as semaglutide, tirzepatide, or masdupitide) at doses specified in the instructions for >= 12 weeks before screening, and who have not discontinued the medication for more than 8 weeks; 3. 24kg/m² = 5% during the use of weekly formulations; 4.Voluntariliy participate in this study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1.People with diabetes (including type 1 diabetes, type 2 diabetes, or other specific types diabetes) ; 2.Currently taking any other weight loss medications, such as orlistat, oral semaglutide, etc. 3.Screen individuals who have undergone weight loss surgery within the past 12 weeks; 4.Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2); 5.Known allergy to the active ingredients or excipients of liraglutide injection, or a history of allergy to GLP-1 receptor agonists; 6.Women of childbearing age who are unwilling to use medically effective contraception deemed reliable by the investigator from the signing of the informed consent to 4 weeks after the end of the study, and women whose pregnancy test results are positive at screening or enrollment, or who are breastfeeding. 7.Exclude participants who have participated in other drug clinical trials within the past 8 weeks (except for observational trials or those confirmed as placebo/blank control). 8.Under the judgment of the researcher, individuals who are not suitable to participate in this study, such as those with other physiological or psychological disorders that may affect compliance, effectiveness, and safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in body weight from baseline at week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in weight, height, and BMI measured by dual-energy X-ray absorptiometry (DXA) at week 12 compared to baseline;Weight and BMI measured by DXA at week 24, changes compared with week 12 and baseline, and percentage changes;At weeks 12 and 24, the proportion of subjects whose body weight was maintained (no increase or decreased) compared with baseline, and the proportion whose weight rebound was below 5% and 10%;Changes in laboratory test indicators based on actual diagnostic and treatment needs at week 12 compared with baseline, and at week 24 compared with baseline and week 12;Muscle Mass,Fat Mass, Lean Body Mass, Android Fat %Gynoid Fat %A/G RatioVAT Volume, Area, MassSAT Volume, Area, Mass;Muscle Mass?Fat Mass?Lean Body Mass ?Android Fat %?Gynoid Fat %?A/G Ratio?VAT Volume, Area, Mass?SAT Volume, Area, Mass;Changes from baseline and percentage changes at week 12 in lean body mass, muscle mass, fat mass, BMI, waist-to-hip ratio, and waist-to-height ratio;Liver stiffness measurement (LSM) and controlled attenuation parameter (CAP) detected by liver transient elastography; | — |
Countries
China
Contacts
Public ContactBi Yan
Nanjing Drum Tower Hospital
Outcome results
None listed