Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Cagrilintide and Semaglutide.

This study looks at how well a new medicine called cagrilintide works together with semaglutide on blood sugar levels in people with type 2 diabetes compared to cagrilintide alone or semaglutide alone.

Participants will either get cagrilintide and semaglutide together or cagrilintide and a dummy medicine or semaglutide and a dummy medicine.

It had three arms (groups): one (experimental), one (active comparator) and one (active comparator).

Participants will receive cagrilintide and semaglutide once a week as injections for 32 weeks.

Participants will receive cagrilintide and placebo (semaglutide) once a week as injections for 32 weeks.

Participants will receive semaglutide and placebo (cagrilintide) once a week as injections for 32 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 92 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: Female of non-childbearing potential or male. Age above or equal to 18 years at the time of signing informed consent. Body mass index (BMI) greater than or equal to 27.0 kg/m\^2. Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening.

The full record lists 6 inclusion and 3 exclusion criteria.

How the Study Was Run

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

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

The Cagrilintide 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 Cagrilintide.

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

It started in 2021-08-02 with completion listed for 2022-07-07.

It ran at 23 sites in United States (23).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Glycated Haemoglobin (HbA1c): Cagrilintide [amount hidden] + Semaglutide [amount hidden] Versus Semaglutide [amount hidden] + Placebo (Cagrilintide).

It also tracked 9 secondary outcomes, for example Number of Treatment Emergent Adverse Events (TEAEs).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cagrilintide and Semaglutide in 92 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Cagrilintide compound page and the Semaglutide compound page, all human trials.