Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.

What Was Tested

This registered phase 2 trial tested Liraglutide.

This study will look at the change in body weight in people taking NNC0174-0833, liraglutide and "dummy" medicine, from the start to the end of the study.

As well as taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight.

Participants will either take NNC0174-0833, liraglutide or "dummy" medicine - which treatment participants get is decided by chance.

It had 12 arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 706 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: 18 years or older at the time of signing the informed consent.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening irrespective of medical records.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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.

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

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

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

It started in 2019-03-01 with completion listed for 2020-03-02.

It ran at 54 sites in United States (22), United Kingdom (7), Canada (5), South Africa (5), Finland (4) and Japan (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Body Weight (%) (time frame: From baseline (week 0) to week 26).

It also tracked 26 secondary outcomes, for example Change in Body Weight (Kg), Change in Waist Circumference, Change in Total Cholesterol, Change in High Density Lipoprotein (HDL) Cholesterol, Change in Low Density Lipoprotein (LDL) Cholesterol and Change in Very Low Density Lipoprotein (VLDL) Cholesterol.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 706 people.

With 706 participants it is a large trial for this field.

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.