ObesityPhase 4NCT07872904
FutureShape Family
A Phase 4 study testing Family Care and Semaglutide (administered by PDS290 pen-injector) in people with Obesity and Overweight, run by Signe Torekov at 1 site in Denmark.
Trial summary
The number of adults and children living with obesity is increasing worldwide. Once childhood obesity has developed, more than 80% of children carry the obesity into adulthood, with a high risk of cardiometabolic disease, poor mental health, and decreased life expectancy. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Family Care and Semaglutide (administered by PDS290 pen-injector)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2026to 31 Jan 2031
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to 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).
- 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.
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- 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.
Who cannot join
- 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 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.
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- 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-informationen.pdf)
- 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.
- 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).
- Known current or previous pancreatitis.
- 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).
- A family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Signe Torekov, Professor contact
Denmark1 site
University of Copenhagen, Department of Biomedical Sciences
Copenhagen, 2200
Study Team, +4593565828, FutureShape@sund.ku.dk
About this study
Official title: FutureShape Family: A Randomised Controlled Trial of an Enhanced Family Care Intervention Targeting Intergenerational Obesity
The number of adults and children living with obesity is increasing worldwide. Once childhood obesity has developed, more than 80% of children carry the obesity into adulthood, with a high risk of cardiometabolic disease, poor mental health, and decreased life expectancy. Parental obesity is a strong predictor of intergenerational obesity and is closely associated with a child's body composition from childhood through to adulthood.
Obesity pharmacotherapy effectively reduces body weight. In adults, we have shown that combining obesity pharmacotherapy with supervised exercise improves weight-loss maintenance compared with pharmacotherapy alone. Emerging evidence suggest that exercise may also limit weight regain after treatment cessation. Together with evidence linking physical activity, sleep, and eating behaviours to weight regulation, these findings support combining pharmacological treatment with interventions targeting multiple modifiable behaviours. Personalised, data-driven feedback may further facilitate sustained behavioural change, but few interventions have integrated these approaches within the family setting.
Read more
This 58-week randomized clinical trial aims to investigate the separate and combined effects of a data-driven, multimodal family-based intervention and semaglutide treatment for parents with obesity on body fat percentage and other health-related outcomes in parents and children.
Approximately 400 families will be randomly assigned to one of four groups combining data-driven, multimodal family-based intervention or standard health advice with semaglutide or placebo. The data-driven, multimodal family-based intervention focuses on physical activity, diet, sleep and mental well-being.
The trial will include families with at least one parent with obesity and at least one child aged 5 to 12 years with overweight or obesity. Participating parents with obesity will receive semaglutide or placebo once weekly for 28 weeks.
The main outcomes are changes in body fat percentage in participating parents and children. Other outcomes include changes in body mass index (BMI) in parents and age- and sex-adjusted BMI, known as BMI z-score, in children. Families will participate in the main trial for 58 weeks and complete an additional follow-up assessment at week 104 after randomization.
- Conditions
- Obesity, Overweight
- Being tested
- Family Care, Standard Care, Semaglutide (administered by PDS290 pen-injector), Placebo (administered by PDS290 pen-injector)
- Keywords
- Family-based intervention, Intergenerational obesity, Physical activity, Diet, Sleep, GLP-1 Receptor Agonist, Digital health, Behavioural intervention, obesity, overweight
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family CareBehavioural
Family Care will be parent-focused but designed to involve the entire family through parent education, individualized guidance based on study assessment and family preferences, supervised exercise sessions (online and on-site) for the families, and feed-back delivered using an app solution and wearable activity trackers.
Standard CareBehavioural
Standard Care consist of recommendations on physical activity, sleep, and dietary habits and will be based on the current recommendations from, e.g., WHO, Nordic Nutrition Recommendations, the American Academy of Sleep Medicine, and the Sleep Research Society.
Semaglutide (administered by PDS290 pen-injector)Drug
Semaglutide (3.2 mg/ml) is self-administered subcutaneously via a PDS290 pen-injector. Treatment will have a duration of 28 weeks and consist of a dose escalation phase (up to 2.4 mg/week) and dose reduction phase.
Placebo (administered by PDS290 pen-injector)Drug
Placebo is self-administered subcutaneously via a PDS290 pen-injector. Treatment will have a duration of 28 weeks and consist of a dose escalation phase (up to 2.4 mg/week) and dose reduction phase.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Family Care | Experimental | Family Care, an enhanced, data driven, multimodal intervention. Index parent(s) will receive s.c. semaglutide for 28 weeks (up to 2.4 mg/week). Receives: Behavioral: Family Care; Drug: Semaglutide (administered by PDS290 pen-injector) |
| Family Care | Active comparator | Family Care, an enhanced, data driven, multimodal intervention. Index parent(s) will receive s.c. placebo for 28 weeks (volume matched with semaglutide). Receives: Behavioral: Family Care; Drug: Placebo (administered by PDS290 pen-injector) |
| Enhanced Standard Care | Active comparator | Standard Care, standard recommendation on diet, sleep, and exercise. Index parent(s) will receive s.c. semaglutide for 28 weeks (up to 2.4 mg/week). Receives: Behavioral: Standard Care; Drug: Semaglutide (administered by PDS290 pen-injector) |
| Standard Care | Placebo comparator | Standard Care, standard recommendation on diet, sleep, and exercise. Index parent(s) will receive s.c. placebo for 28 weeks (volume matched with semaglutide). Receives: Behavioral: Standard Care; Drug: Placebo (administered by PDS290 pen-injector) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body fat percentage
In Index Parent(s) and Index Child(ren): Dual-energy X-ray absorptiometry scans will be performed in fasting state to measure body fat percentage (%).
Measured: Change from baseline to end-of-treatment (58 weeks)
Secondary outcomes (5)
Change in body weight
In Index Parent(s) and Index Child(ren): Weight will be measured to the nearest 0.1 kg and should be measured in a fasting state.
Measured: Change from baseline to end-of-treatment (58 weeks)
Change in BMI
In Index Parent(s): Weight will be measured to the nearest 0.1 kg and should be measured in a fasting state. Height will be measured to the nearest 0.1 cm.
Measured: Change from baseline to end-of-treatment (58 weeks)
Change in BMI-Z score
In Index Child(ren): Weight will be measured to the nearest 0.1 kg and should be measured in a fasting state. Height will be measured to the nearest 0.1 cm.
Measured: Change from baseline to end-of-treatment (58 weeks)
Change in body composition
In Index Parent(s) and Index Child(ren): Dual-energy X-ray absorptiometry and bioimpedance scans will be performed in fasting state to measure fat free mass and fat mass in kg.
Measured: Change from baseline to end-of-treatment (58 weeks)
Change in waist-to-height ratio
In Index Parent(s) and Index Child(ren): Waist circumference in cm divided by height in cm.
Measured: Change from baseline to end-of-treatment (58 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 May 2030 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Signe Torekov
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Hvidovre University Hospital, Herlev Hospital, Psychiatric Center Ballerup, The Research and Implementation Unit PROgrez, Region Zealand,Denmark, Sorbonne University, Mayo Clinic, Harvard University
- Responsible party
- Sponsor-investigator, Signe Torekov, University of Copenhagen
- Investigators
- Signe Torekov, Professor, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872904
- Sponsor's protocol ID
- U1111-1324-8628
- Other IDs
- NNF24OC0088515, 2025-0304, U1111-1324-8628, NNF22SA0079901, U1111-1324-8628, NNF20SA0067242, H-25043094
- Status last verified
- Aug 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will be in accordance with EU and General Data Protection Regulation requirements and applicable local regulations, and in accordance with trial protocol and statistical analysis plan.
Publications
Ward ZJ, Long MW, Resch SC, Giles CM, Cradock AL, Gortmaker SL. Simulation of Growth Trajectories of Childhood Obesity into Adulthood. N Engl J Med. 2017 Nov 30;377(22):2145-2153. doi: 10.1056/NEJMoa1703860.
PubMed 29171811Geserick M, Vogel M, Gausche R, Lipek T, Spielau U, Keller E, Pfaffle R, Kiess W, Korner A. Acceleration of BMI in Early Childhood and Risk of Sustained Obesity. N Engl J Med. 2018 Oct 4;379(14):1303-1312. doi: 10.1056/NEJMoa1803527.
PubMed 30281992Hampl SE, Hassink SG, Skinner AC, Armstrong SC, Barlow SE, Bolling CF, Avila Edwards KC, Eneli I, Hamre R, Joseph MM, Lunsford D, Mendonca E, Michalsky MP, Mirza N, Ochoa ER, Sharifi M, Staiano AE, Weedn AE, Flinn SK, Lindros J, Okechukwu K. Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity. Pediatrics. 2023 Feb 1;151(2):e2022060640. doi: 10.1542/peds.2022-060640. No abstract available.
PubMed 36622115Mead E, Brown T, Rees K, Azevedo LB, Whittaker V, Jones D, Olajide J, Mainardi GM, Corpeleijn E, O'Malley C, Beardsmore E, Al-Khudairy L, Baur L, Metzendorf MI, Demaio A, Ells LJ. Diet, physical activity and behavioural interventions for the treatment of overweight or obese children from the age of 6 to 11 years. Cochrane Database Syst Rev. 2017 Jun 22;6(6):CD012651. doi: 10.1002/14651858.CD012651.
PubMed 28639319Epstein LH, Wilfley DE, Kilanowski C, Quattrin T, Cook SR, Eneli IU, Geller N, Lew D, Wallendorf M, Dore P, Paluch RA, Schechtman KB. Family-Based Behavioral Treatment for Childhood Obesity Implemented in Pediatric Primary Care: A Randomized Clinical Trial. JAMA. 2023 Jun 13;329(22):1947-1956. doi: 10.1001/jama.2023.8061.
PubMed 37314275McDarby F, Looney K. The effectiveness of group-based, parent-only weight management interventions for children and the factors associated with outcomes: a systematic review. Int J Obes (Lond). 2024 Jan;48(1):3-21. doi: 10.1038/s41366-023-01390-6. Epub 2023 Oct 11.
PubMed 37821651Jensen SBK, Blond MB, Sandsdal RM, Olsen LM, Juhl CR, Lundgren JR, Janus C, Stallknecht BM, Holst JJ, Madsbad S, Torekov SS. Healthy weight loss maintenance with exercise, GLP-1 receptor agonist, or both combined followed by one year without treatment: a post-treatment analysis of a randomised placebo-controlled trial. EClinicalMedicine. 2024 Feb 19;69:102475. doi: 10.1016/j.eclinm.2024.102475. eCollection 2024 Mar.
PubMed 38544798Lundgren JR, Janus C, Jensen SBK, Juhl CR, Olsen LM, Christensen RM, Svane MS, Bandholm T, Bojsen-Moller KN, Blond MB, Jensen JB, Stallknecht BM, Holst JJ, Madsbad S, Torekov SS. Healthy Weight Loss Maintenance with Exercise, Liraglutide, or Both Combined. N Engl J Med. 2021 May 6;384(18):1719-1730. doi: 10.1056/NEJMoa2028198.
PubMed 33951361Bogh AF, Jensen SBK, Juhl CR, Janus C, Sandsdal RM, Lundgren JR, Noer MH, Vu NQ, Fiorenza M, Stallknecht BM, Holst JJ, Madsbad S, Torekov SS. Insufficient sleep predicts poor weight loss maintenance after 1 year. Sleep. 2023 May 10;46(5):zsac295. doi: 10.1093/sleep/zsac295.
PubMed 36472579