Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With Obesity

What Was Tested

The trial (phase 1) is built around Liraglutide.

This trial is conducted in the United States of America.

It had two arms (groups): NNC9204-0530 / Placebo and Liraglutide 1.8 (experimental) and NNC9204-0530 /Placebo and Liraglutide 3.0 (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 187 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Body mass index between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening. Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: any prior obesity surgery or currently present gastrointestinal implant; thyroid-stimulating hormone (tsh) values outside 0.4-6.0 miu/l; A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome).

How the Study Was Run

The set-up was 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 2016-08-18 with completion listed for 2017-09-03.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of treatment emergent adverse events (time frame: Day 1-112).

It also tracked 3 secondary outcomes, for example Area under the NNC9204-0530 serum concentration-time curve, Time to maximum serum concentration of NNC9204-0530 and Change in HbA1C.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 187 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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