DelfaGLP-1 Atlas

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Active not recruiting

Semaglutide and Physical Activity for Obesity and Multimorbidity

Semaglutide and Physical Activity for Obesity and Multimorbidity: Co-designing Healthy Healthcare

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

1

Recruiting sites

—

Enrollment

35

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥35

Primary endpoint

•Habitual physical activity

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06234111
Org study IDF-23061071

Timeline

Milestones

Study first posted2024-01-31actual
Study start2024-02-20actual
Last update posted2024-12-12actual
Primary completion2026-10estimated (month precision)
Study completion2026-11estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-allSemaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Individuals living in the Capital Region of Denmark can be referred to the weight loss program if they fulfill the Danish criteria for bariatric surgery while having comorbidities that increase the risk of surgery or challenge the accompanying necessary lifestyle changes, thereby making them ineligible for bariatric surgery. Consequently, most patients in the weight loss program are severely burdened by high levels of obesity (usually BMI \> 40 kg/m2) and have debilitating somatic and mental multimorbidity (corresponding to Edmonton Obesity Staging System stages 2-4). In other words, patients for whom a substantial and sustained weight loss is expected to lead to tangible and significant health benefits.

Inclusion criteria

Study participants are recruited from a particular interdisciplinary weight loss program based at Copenhagen University Hospital Hvidovre. Hence, the study uses the same set of inclusion criteria:

Inclusion criteria:

•Fulfilment of the Danish criteria for bariatric surgery:
•BMI ≥ 35 kg/m2
•Aged ≥ 18 years
•One or more obesity-related conditions (type II diabetes, resistant hypertension, sleep apnea, severe osteoarthritis of the lower extremities)
•One more comorbidities that prevent bariatric surgery

Exclusion criteria

are:

•Unwillingness to participate in the study
•Inability to understand Danish
•Cognitive impairments

UPDATE 17.09.2024:

After initiating patient recruitment for the study on 15.02.2024, the project group identified discrepancies between the eligibility criteria and description of the study population as originally reported in the trial registration and those actually applied in the study. As a result, we adjusted both the eligibility criteria and description of the study population in the trial registration on 17.09.2024. These adjustments do not represent a change in the actual patient population but rather offer a more accurate and consistent description of their characteristics.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers
3
Patient-reported / QoL
3
Other clinical outcomes
3
Weight & body composition
2
Heart failure
1

Weight & body composition

2 endpoints
Other/protocol endpoint

Body weight

Time frame:Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).

Body weight, % change

percent change from baseline, improvement

Other/protocol endpoint

Waist circumference

Time frame:Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).

Waist circumference, change

change from baseline, improvement

Heart failure

1 endpoint
Other/protocol endpoint

Walking capacity and endurance

Time frame:Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).

6-minute walk distance

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

10-years cardiovascular risk (previous cardiovascular disease)

Time frame:Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).

change from baseline, improvement

Secondary/protocol endpoint/low confidence

10-years cardiovascular risk (type 2 diabetes)

Time frame:Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).

descriptive, improvement

Secondary/protocol endpoint

10-years cardiovascular risk (apparently healthy)

Time frame:Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).

change from baseline, improvement

Patient-reported / QoL

3 endpoints
Secondary/protocol endpoint

Health-related quality of life: physical

Time frame:Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).

SF-36 physical

change from baseline, improvement

Other/protocol endpoint

Health-related quality of life: mental

Time frame:Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).

SF-36 mental

change from baseline, improvement

Other/protocol endpoint

Weight bias internalization

Time frame:Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).

change from baseline, improvement

Other clinical outcomes

3 endpoints
Primary/protocol endpoint

Habitual physical activity

Time frame:Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).

change from baseline, improvement

Other/protocol endpoint

Cardiorespiratory fitness

Time frame:Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).

change from baseline, improvement

Other/protocol endpoint

Lower body strength

Time frame:Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.