Multiple Ascending Dose Study of AMG 598 in Adults With Obesity

What Was Tested

In this phase 1 trial, researchers set out to test Liraglutide.

It had eight arms (groups): Placebo (placebo comparator), Placebo + Liraglutide (active comparator), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

50 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Men and women with ages between 18 and 65 years old, inclusive, at time of signing consent. Body mass index (BMI) between greater than or equal to 30.0 kg/m\^2 and less than or equal to 40.0 kg/m\^2 at screening. Except for obesity, otherwise healthy or medically stable per protocol. Have a stable body weight defined as less than 5 kg self-reported change during the previous 8 weeks prior to screening. Other Inclusion criteria may apply.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: history or clinical evidence of diabetes; inadequate organ function at screening; currently receiving treatment in another investigational device or drug study.

How the Study Was Run

Design: randomized, sequential and double-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.

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 2018-11-26 with completion listed for 2019-12-16.

It ran at 4 sites in United States (4).

Its stated primary purpose is other.

What Was Measured

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (time frame: 207 days). Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings (time frame: 207 days).

It also tracked 9 secondary outcomes, for example Maximum Observed Concentration (Cmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57, Time to Maximum Observed Concentration (Tmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57, Area Under the Concentration-time Curve From Time 0 to 28 Days (AUC0-28) for AMG 598 After Subcutaneous Injection on Day 1 and Day 57, Accumulation Ratio (AR) for Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57, Accumulation Ratio of AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57 and Terminal Half-life (T1/2,z) of AMG 598 After Subcutaneous Injection on Day 57.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 50 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.