FutureShape Family

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide.

It had four arms (groups): Enhanced Family Care (experimental), Family Care (active comparator), Enhanced Standard Care (active comparator) and Standard Care (placebo comparator).

Family Care, an enhanced, data driven, multimodal intervention. Index parent(s) will receive s.c. placebo for 28 weeks (volume matched with semaglutide).

The registry classes the interventions as behavioral and drug.

Who Took Part

400 planned participants were the target.

It was open to people of any sex aged from 5 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Family living in the same household with at least one Index Parent and one Index Child living with overweight/obesity (see below). Written informed consent from all adult participants (age ≥18 years), participants between the ages of 15-17 years, and from the parental authority of the children (age \<18 years). Living with obesity (BMI ≥30 kg/m2). Biological, adoptive parent, or legal guardian of the Index child. Index parent(s) must be in possession of a smartphone and able to use an app-based solution.

The full record lists 8 inclusion and 16 exclusion criteria; among the exclusions: known serious chronic conditions, including type 1 or 2 diabetes; treatment for cancer at screening other than oestrogen antagonist therapy or non-melanoma skin cancer; known diagnosis or treatment for an eating disorder within the last 6 months.

How the Study Was Run

The set-up was randomized, factorial and quadruple-blind.

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

As a double-blind Semaglutide 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 2026-10-01 with completion listed for 2030-05-31.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in body fat percentage (time frame: Change from baseline to end-of-treatment (58 weeks)).

It also tracked 5 secondary outcomes, for example Change in body weight, Change in BMI, Change in BMI-Z score, Change in body composition and Change in waist-to-height ratio.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 400 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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