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

What Was Tested

This registered phase 3 trial tested Liraglutide.

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.

It had two arms (groups): Liraglutide (experimental) and Placebo (placebo comparator).

Liraglutide Injection, once a day, injected subcutaneously on abdomen, thigh or upper arm.

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

The registry classes the interventions as drug.

More on the Plan

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial.

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.

Who Took Part

The registry lists 414 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Those voluntarily participating and signing the ICF. Those aged 18-70 years old (including 18 and 70 years old), without restriction on male and female. Those failing to control their body weight in previous diet therapy alone. Those voluntarily following the medication, diet and exercise requirements decided by the investigators. Those with a stable body weight (patient reported body weight change \< 5 kg) in last 3 months.

The full record lists 11 inclusion and 31 exclusion criteria; among the exclusions: those with type 1 diabetes or secondary diabetes; those with acute metabolic complications such as diabetic ketoacidosis or hyperglycemia (coma) within 6 months before screening; those receiving glp-1 receptor agonist, dpp-4 inhibitors, sglt-2 inhibitor, or insulin therapy within 3 months prior to screening.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Liraglutide group and the comparison group ran side by side rather than switching.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2020-08-18 with completion listed for 2022-12-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The percentage of body weight loss (time frame: through study completion, an average of 32 weeks). The proportion of body weight loss ≥ 5 percent (time frame: through study completion, an average of 32 weeks).

It also tracked 9 secondary outcomes, for example Changes in waist circumference, Changes in diastolic pressure and systolic pressure, Changes in pulse of the subjects, The changes in blood lipid, The changes in blood glucose and The changes in HbA1c.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 414 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.