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

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT04605861
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Liraglutide — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 18, 2020
Status verified
Jun 2023
Primary completion
Dec 31, 2022
Completion
Apr 15, 2023

Study Design

Enrollment
414 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide
    Liraglutide Injection, once a day, injected subcutaneously on abdomen, thigh or upper arm.
  • Placebo Comparator: Placebo
    Placebo (Liraglutide Injection simulator), once a day, injected subcutaneously on abdomen, thigh or upper arm.

Primary Outcome Measure

The percentage of body weight loss [ Time Frame: through study completion, an average of 32 weeks ]

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