A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight

What Was Tested

This registered phase 2 trial tested Tirzepatide.

This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight.

Participants will take 1-2 injections once a week.

It had 13 arms (groups): one (experimental), one (placebo comparator), one (experimental), one (placebo comparator) and one (experimental).

Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 354 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Female of non-childbearing potential, or male. Age 18-75 years (both inclusive) at the time of signing the informed consent. History of at least one self-reported unsuccessful dietary effort to lose body weight. A) BMI ≥ 27.0 kg/m2 with the presence of at least one weight-related co-morbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. B) BMI ≥ 30.0 kg/m2.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes mellitus; treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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

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 Tirzepatide.

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

It started in 2024-03-18 with completion listed for 2025-04-10.

It ran at 70 sites in United States (49), Australia (19) and Japan (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Relative change in body weight (time frame: From baseline (week 0) to end of treatment (week 36)).

It also tracked 20 secondary outcomes, for example Change in body weight, Change in body mass index (BMI), Change in waist circumference, Change in glycated hemoglobin (HbA1c), Change in fasting plasma glucose (FPG) and Change in systolic blood pressure (SBP).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 354 people.

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

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