FutureShape Family

Prior treatment

• Known medical conditions or use of medication significantly affecting growth (Index Child) or causing clinically significant weight gain or weight loss (Index Parent(s) or Index Child) within the last 6 months before screening.
• Bariatric surgery and weight-related surgeries (e.g., gastric bypass) within the last two years.
  • Relating to semaglutide (Index Parent(s)) (according to the SmPC: https://www.ema.europa.eu/en/documents/product-information/wegovy-epar-product-information\_en.pdf)
• Known current or previous pancreatitis.

Other illness

• Known serious chronic conditions, including type 1 or 2 diabetes
• Known medical conditions that hinder physical activity to a significant degree.
• Treatment for cancer at screening other than oestrogen antagonist therapy or non-melanoma skin cancer.
• Known severe psychiatric disease, a history of major depressive episodes, or other serious psychiatric disorders.
• Known diagnosis or treatment for an eating disorder within the last 6 months
• Known severe hepatic impairment.
• Known severe stomach or gut problem, which results in delayed stomach emptying (called gastroparesis), or if you have an inflammatory bowel disease.
• Known congestive heart failure, New York Heart Association (NYHA) class IV.
• Known diabetic eye disease (retinopathy).
• A family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma

Lab values

• Hypersensitivity to the active substance (semaglutide) or to any of the excipients used (Disodium phosphate, dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide, propylene glycol, phenol).
• Known severe renal impairment (eGFR \<30 mL/min/1.73m2), including participants with end-stage renal disease.

Other

• Pregnancy, expecting pregnancy (during the study), or breastfeeding. If a study participant is in doubt whether they could be pregnant, a urine pregnancy test is performed. Adequate contraception must be used throughout the study period and at least 2 months after discontinuation of semaglutide (semaglutide is present in the circulation for 7 weeks after the last dose).

• 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).
• Permanent residency in Denmark and able to speak Danish at a level to understand trial requirements.
  • Index Parent(s):
• Living with obesity (BMI ≥30 kg/m2).
• Biological, adoptive parent, or legal guardian of the Index child.
• Resides with the Index child at least 50% of the time.
• Index parent(s) must be in possession of a smartphone and able to use an app-based solution
• A maximum of two Index Parents per family can participate in the trial.
  • Index Child(ren):
• Aged 5 to 12 years with overweight or obesity (BMI \> +1 BMI z-score (\>85th percentile) for age and sex assigned at birth).
  • Other members of the household:
• All other members (non-Index parent(s) and non-Index child(ren)) of the household are invited to be included in the study and participate partly by wearing an accelerometer, wrist-worn activity tracker (e.g., a smartwatch), physical activity testing, answering questionnaires, and measurements of weight and body composition.