Lifestyle Modification and Liraglutide

What Was Tested

This registered phase 4 trial tested Liraglutide.

This is a 52 week, single center, open-labeled, randomized controlled trial.

A total of 150 subjects with obesity, who are free of types 1 and 2 diabetes, as well as contraindications to weight loss, will be randomly assigned to one of three treatment groups: 1) lifestyle counseling, as currently recommended by the Centers for Medicare and Medicaid Services (CMS) (i.e., CMS-Alone); 2) CMS lifestyle counseling plus liraglutide (i.e., CMS-Liraglutide); or 3) CMS-Liraglutide plus a portion-controlled diet (i.e., Multi-Component Intervention).

Subjects in all three groups will have 14 brief (15 minute) lifestyle counseling visits the first 24 weeks, followed by monthly visits in weeks 25-52.

It had five arms (groups): CMS-Alone (active comparator), CMS-Liraglutide (active comparator), Multi-Component Intervention (active comparator), 12-Week Extension Study: Phentermine Group (active comparator) and 12-Week Extension Study: Placebo Group (active comparator).

Lifestyle counseling, as currently recommended by the CMS.

CMS lifestyle counselling plus liraglutide.

CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks.

The registry classes the interventions as behavioral, drug and other.

More on the Plan

The addendum to the original 52-week trial, is a 12-week, single center, randomized placebo-controlled, parallel group designed trial.

This 12-week extension study is separate from the original 52-week trial and will not affect the outcome or analysis of the 52-week, 3-arm trial.

Participants in both groups will receive liraglutide in an open-label manner.

The researchers anticipate that 23 (of 50) participants from the original CMS-Liraglutide group and 23 (of 50) from the Multi-Component Intervention will be eligible to participate in the extension study and will elect to do so.

Who Took Part

Enrollment: 150 actual participants took part.

It was open to people of any sex aged from 21 years up to 70 years.

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

Examples of who could join: Participants must have a BMI ≥ 30 and ≤ 55 kg/m². Age ≥ 21 years and ≤ 70 years. Eligible female patients will be:. Non-pregnant, evidenced by a negative urine dipstick pregnancy test. Surgically sterile or postmenopausal, or they will agree to continue to use an accepted method of birth control during the study.

The full record lists 12 inclusion and 31 exclusion criteria; among the exclusions: pregnant or nursing, or plans to become pregnant in the next 18 months, or not using adequate contraceptive measures; personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2; uncontrolled hypertension (systolic blood pressure ≥ 160 mm hg or diastolic blood pressure ≥ 100 mm hg).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2016-09 with completion listed for 2018-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change in Baseline Weight (time frame: Randomization and 52 weeks). Extension Study Primary Outcome: Percent Change in Re-randomization Weight (time frame: Re-randomization and 12 weeks).

It also tracked 32 secondary outcomes, for example Change in Systolic Blood Pressure, Change in Diastolic Blood Pressure, Change in Heart Rate, Change in Waist Circumference, Change in Total Cholesterol and Change in LDL Cholesterol.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 150 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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