A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants

What Was Tested

In this phase 2 trial, researchers set out to test Liraglutide.

The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo after 26 weeks of treatment on the percent change in body weight from baseline and to assess the safety and tolerability, in non-diabetic severely obese participants.

The registry classes the interventions as drug.

Who Took Part

The registry lists 474 actual participants took part.

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

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

Examples of who could join: Body mass index (BMI) greater than or equal to (\>=) 35 to less than or equal to (\<=) 50 kilogram per square meter (kg/m\^2) at the screening visit. Stable weight (that is, change of \<= 5 percent \[%\] within 12 weeks before screening based on medical history). Woman of childbearing potential have a negative pregnancy test at screening. Willing and able to adhere to specific the prohibitions and restrictions.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: history of obesity with a known secondary cause (for example, cushing's disease/syndrome); history of type 1 diabetes mellitus, type 2 diabetes mellitus (t2dm), diabetic ketoacidosis (dka), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy; history of glucagonoma.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2018-03-26 with completion listed for 2019-03-08.

It ran at 51 sites in United States (17), Belgium (8), Canada (7), Sweden (7), United Kingdom (7) and Poland (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change From Baseline in Body Weight at Week 26 (time frame: Baseline, Week 26). Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Up to Week 30).

It also tracked 3 secondary outcomes, for example Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26 and Change From Baseline in Body Weight at Week 26.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 474 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.