Efficacy and Safety of Liraglutide on Body Weight in Obese Subjects or Overweight Subjects With Co-morbidities

What Was Tested

The trial (phase 3) is built around Liraglutide.

The researchers performed a multicenter, randomized, double-blind, placebo-controlled 28-week trial. 300 non-diabetic obese subjects or overweight subjects with co-morbidities were randomly assigned.

Eligible participants were randomized 2:1 to once-daily subcutaneous injections of either liraglutide or placebo.

The primary outcome is to investigate the safety, tolerability from baseline to end of treatment.

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

The registry classes the interventions as drug.

More on the Plan

The researchers performed a multicenter, randomized, double-blind, placebo-controlled 28-week trial. 300 individuals (18-75 years of age, body-mass index ≥30 kg/m2 or BMI 27-30kg/m2 accompanied by at least one weight-related complication (treated or untreated hypertension, dyslipidemia, pre-diabetes)) were randomly assigned.

All the patients provided written informed consent before participation.

The primary endpoint was change in bodyweight during the 28 weeks of the study in the intention-to-treat population.

Who Took Part

Enrollment: 300 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Informed consent obtained before any trial-related activity takes place. Age ≥18 years, ≤75 years.

The full record lists 3 inclusion and 31 exclusion criteria; among the exclusions: diagnosis of type 1 or type 2 diabetes per the judgment of the investigator; less than 5 kg self-reported change during the previous 3 months; previous treatment with glp-1 receptor agonists (including liraglutide or exenatide) within the last 3 months.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-05-09 with completion listed for 2022-06.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean Change From Baseline in Fasting Body Weight (time frame: Week 0, Week 28).

It also tracked 2 secondary outcomes, for example Mean Change From Baseline in Waist Circumference (cm).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 300 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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