DelfaGLP-1 Atlas

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DUTCH-WAIST

RecruitingPhase 4

DUTCH Weight Control in Atrial Fibrillation Study

DUTCH Weight Control in Atrial Fibrillation Study, a Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled Trial

Lead sponsor

Rijnstate Hospital

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

280

estimated

Study population

Atrial fibrillation, Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Atrial-fibrillation composite (Atrial-fibrillation composite, All-cause death)

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 IDNCT06184633
Org study IDU1111-1275-9989

Timeline

Milestones

Study first posted2023-12-28actual
Study start2024-07-21actual
Last update posted2024-09-19actual
Primary completion2026-05-01estimated
Study completion2027-05-01estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Atrial fibrillationObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Symptomatic, first detected (at maximum 6 months prior to enrollment) persistent AF -
•Age ≥ 18
•Obesity, as defined as:
–BMI ≥ 30 kg/m2, or
–BMI ≥27 kg/m2 with the presence of at least one weight related comorbidity (treated or untreated, e.g. hypertension, dyslipidaemia, obstructive sleep apnea, cardiovascular disease)
•Scheduled ECV
•Written informed consent

Exclusion criteria

•Permanent AF
•Secondary AF, i.e. due to thyrotoxicosis, infection (e.g. pneumonia) or post-(cardiothoracic) surgery
•Current or previous treatment with amiodaron
•HbA1c ≥ 48 mmol/L, <3 months prior to randomization
•History of diabetes mellitus type 1 or 2
•Prior bariatric surgery
•Use of other anti-obesity medication, <3 months prior to enrollment
•Contra-indication for, or prior use of a GLP1-receptor agonist
•History of chronic pancreatitis or acute pancreatitis <6 months
•Acute coronary syndrome <6 months
•Severe (grade III) valvular disease
•eGFR <30 mL/min/1.73m2
•Heart failure NYHA class III-IV
•Participation in another investigational drug or device study in the past 30 days (registry enrollment is allowed)
•Any condition or therapy, which would make the participant unsuitable for the study (e.g. vulnerable, non-compliance) or life-expectancy <12 months, as judged by the treating physician.
•Female who is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.

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

Cardiovascular outcomes
6
Weight & body composition
3
Patient-reported / QoL
2
Safety / tolerability / PK
1

Cardiovascular outcomes

6 endpoints
Primary/protocol endpoint

The primary efficacy clinical endpoint of the trial is assessed at 12 months by a 7 point scale. Only the worst clinical outcome will be retained as the primary efficacy outcome

Time frame:At 1 year follow-up

Atrial-fibrillation composite

categorical status, event

componentsAtrial-fibrillation composite, All-cause death

Secondary/protocol endpoint

Number of hospitalizations because of an AF recurrence.

Time frame:week 0-52

Atrial-fibrillation composite

event count, event

Secondary/protocol endpoint

Number of scheduled electrical cardioversions.

Time frame:week 0-52

event count, event

Secondary/protocol endpoint/low confidence

Number of unscheduled electrical cardioversions.

Time frame:week 0-52

event count, event

Secondary/protocol endpoint

Number of intravenous chemical cardioversions (using Vaughan-Williams class I drugs).

Time frame:week 0-52

Atrial-fibrillation composite

event count, event

Secondary/protocol endpoint

Total number of unscheduled cardioverions.

Time frame:week 0-52

Atrial-fibrillation composite

event count, event

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Change in waist circumference, measured in cm

Time frame:week 0 and 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in weight, measured in % and kg

Time frame:week 0 and 52

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI, measured in kg/m2

Time frame:week 0 and 52

BMI, change

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Change in AF related symptoms measured by the modified EHRA classification between the index visit and at 12 months after the index visit.

Time frame:week 0 and 52

change from baseline, improvement

Secondary/protocol endpoint

Change in quality of life measured by the EQ-5D-5L between the index visit and at 12 months after the index visit.

Time frame:week 0 and 52

EQ-5D index

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number of unscheduled hospital visits because of adverse events of AAD.

Time frame:week 0-52

event count, event

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.