The Role of the Amylin Analogue Cagrilintide in Bone Metabolism

What Was Tested

In this phase 1 trial, researchers set out to test Cagrilintide and Semaglutide.

In this study the researchers will investigate how the medicine cagrilintide affects bone health in women after menopause with obesity during weight loss, compared to treatment with placebo (the dummy medicine with no active substances) and semaglutide.

Participants will either get cagrilintide, semaglutide, CagriSema (cagrilintide combined with semaglutide) or placebo.

It had four arms (groups): Cagrilintide (experimental), Semaglutide (experimental), CagriSema (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 144 planned participants were the target.

It was open to women only aged from 50 years up to 70 years.

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

Examples of who could join: Age 50-70 years (both inclusive) at the time of signing the informed consent. Body Mass Index (BMI) greater than or equal to \>= 30.0 kilograms per square meter (kg/m\^2).

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: previous or current bone disease (e.g., osteoporosis, paget's disease of bone, or bone cancer).

How the Study Was Run

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

Because people in this Cagrilintide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Cagrilintide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2025-06-12 with completion listed for 2028-05-03.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Relative change in volumetric bone mineral density (vBMD) of the total hip assessed by quantitative computed tomography (QCT) (time frame: From baseline to end of treatment (week 68)).

It also tracked 13 secondary outcomes, for example Relative changes in vBMD of the lumbar 1 (L1) - L4 vertebrae assessed by QCT, Relative changes in vBMD of the radius assessed by QCT, Relative changes in vBMD of the L1 - L4 vertebrae assessed by QCT, Relative changes in vBMD of the radius assessed by QCT, Relative change in the Ki (bone turnover) of the femoral neck assessed by fluoride - positron emission tomography (PET) and Relative change in the Ki (bone turnover) of the femoral neck assessed by fluoride - PET.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cagrilintide and Semaglutide in 144 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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