The Efficacy and Safety of Liraglutide on Body Weight Loss in Obese and Overweight Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obese
- Overweight
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. The total study duration is 34~36 weeks, including 2-week screening, 6~8-week dosage titration, 24-week stable treatment and 2-week safety follow-up.Masking: Double (Participant, Investigator)Masking Description: Regardless of treatment allocations, each subject receive the same total volume of investigational drug or placebo. All drug automatic injectors and kits, study drugs or placebo are identical in appearance and labels to blind subjects and investigators. This can minimize the bias of investigators and subjects on treatment evaluation.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. The total study duration is 34~36 weeks, including 2-week screening period, 6~8-week dosage titration, 24-week stable treatment and 2-week safety follow-up period. Subjects with obesity or overweight with c...
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. The total study duration is 34~36 weeks, including 2-week screening period, 6~8-week dosage titration, 24-week stable treatment and 2-week safety follow-up period. Subjects with obesity or overweight with comorbidity of metabolic disorders receive subcutaneous injection of 3.0 mg Liraglutide or placebo every day. The primary endpoint is the change of body weight or the percentage of body weight loss greater than 5%. The changes of body weight between Liraglutide Injection group and placebo group will be compared. In the course of the trial, the subjects are weighted on fasting state. Blood samples are collected according to the protocol. All subjects receive lifestyle intervention, including a reductiong of calorie intake by 500 kcal a day and physical exercise.
Tracking Information
- NCT #
- NCT04605861
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Xiaoying Li, MD Fudan University
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