NCT04605861

The Efficacy and Safety of Liraglutide on Body Weight Loss in Obese and Overweight Patients

A Multicenter, Randomized, Double-blinded, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of Liraglutide on Body Weight Loss in Obese and Overweight Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 414 (actual)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect and safety of Liraglutide Injection on body weight loss compared with placebo in obese or overweight adult patients with comorbidity of metabolic disorders.

Detailed 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 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.

Conditions

• Obese
• Overweight

Interventions

Type	Name	Description
DRUG	Liraglutide	Liraglutide Injection, once a day, injected subcutaneously on the sites of abdomen, thigh or upper arm. The initial dose of Liraglutide Injection will be 0.6 mg per day. The dose is escalated every one to two weeks to reduce the gastrointestinal symptoms. At Week 7, the dose is increased to 3.0 mg per day. For the subjects who are not able to tolerate the target dose of 3.0 mg,the dose is reduced to 2.4 mg a day and escalated to the dose to 3.0 mg within two weeks. If the subjects are still unable to tolerate this dose (3.0 mg), the treatment is terminated.
DRUG	Placebo	Placebo Injection, once a day, injected subcutaneously on the sites of abdomen, thigh or upper arm. The initial dose of Placebo Injection will be 0.6 mg per day. The dose is escalated every one to two weeks to reduce the gastrointestinal symptoms. At Week 7, the dose is increased to 3.0 mg per day. For the subjects who are not able to tolerate the target dose of 3.0 mg,the dose is reduced to 2.4 mg a day and escalated to the dose to 3.0 mg within two weeks. If the subjects are still unable to tolerate this dose (3.0 mg), the treatment is terminated.

Timeline

• Start date: 2020-08-18
• Primary completion: 2022-12-31
• Completion: 2023-04-15
• First posted: 2020-10-28
• Last updated: 2023-06-07

Locations

1 site across 1 country: China