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Semaglutide

Ozempic, Rybelsus, Wegovy

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Studies 78
Trials 100
Active Not Recruiting OBSERVATIONAL NCT06234111

Semaglutide and Physical Activity for Obesity and Multimorbidity

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The aim of this observational study is to explore and describe changes in cardiometabolic health, physical activity, physical capacity, and wellbeing during interdisciplinary Semaglutide-based weight loss treatment in patients with severe obesity and multimorbidity. This study is explorative and therefore does not include hypothesis testing.

Detailed Description

This study is part of the project "Semaglutide and Physical Activity for Obesity and Multimorbidity: Co-designing Healthy Healthcare". While this observational quantitative study aims to provide a comprehensive description of changes in patients' health and wellbeing during and after participation in weight loss treatment, the project also includes a qualitative interview study with a subset of patients from the same population to supplement and expand upon the quantitative findings. Additionally, a smaller subgroup of patients from the same population will eventually be invited to actively contribute to the collaborative development of a physical activity intervention in a co-design process, drawing on insights from the aforementioned studies. Given its exploratory approach, the study is designed with a flat non-hierarchical outcome structure and multiple evenly valued outcomes measures. This will be reported evenly for all outputs of this research.

Interventions

Name: Semaglutide 2.4 mg, total diet replacement, behavioural intervention
Type: COMBINATION_PRODUCT
Description: Patients receive a highly specialized interdisciplinary weight loss treatment comprising two phases. Firstly, they engage in a total diet replacement using Nupo for approximately three months to induce a maximal weight loss. After this and for the duration of the entire treatment period, patients receive Semaglutide 2.4 mg and behavioural dietary support to maintain the weight loss and improve health. The total treatment period is two years.

Primary Outcomes

Measure: Habitual physical activity
TimeFrame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Description: SENS Motion accelerometry will be used to measure habitual physical activity, defined as time spent non-sedentary and not lying down. We will measure for seven full days. Data will be presented as mean change in hours/day spent physically active between baseline, four months, and follow-up. As mentioned, the study is exploratory and designed with a flat outcome hierarchy and multiple evenly valued outcome measures. The registration template requires that one outcome is listed as "primary", which is why this one is listed. This does not mean we consider this outcome more important than other outcomes.

Trial Information

NCT ID

NCT06234111

Status

Active Not Recruiting

Study Type

OBSERVATIONAL

Sponsor

Hvidovre University Hospital

Last Updated

December 15, 2025