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Atrial FibrillationPhase 3SOCRATES-AFNCT04885634

Semaglutide for the Reduction of Arrhythmia Burden in Overweight AF Patients

A Phase 3 study testing Semaglutide Injectable Product in people with Atrial Fibrillation and Overweight and Obesity, run by Axel Brandes.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this pilot study is to assess the feasibility of a double-blind, randomized placebo-controlled trial of semaglutide 2.4 mg subcutaneously once weekly on top of standard care compared to standard care alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Overweight and Obesity
What is being tested?
Semaglutide Injectable Product
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Oct 2022to Nov 2024
Phase
Phase 3
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent before any study-related activity
  • ≥ 18 years of age at the time of signing informed consent
  • Body mass index (BMI) ≥ 30 kg/m2
  • Body mass index (BMI) ≥ 27 kg/m2 and at least 1 concomitant cardiometabolic risk factor (hypertension, dyslipidemia, or obstructive sleep apnea)
  • Symptomatic paroxysmal or early persistent atrial fibrillation (Paroxysmal AF: Self- terminating, in most cases within 48 hours up to 7 days. AF episodes that are cardioverted within 7 days with a documented 12 lead ECG showing sinus rhythm within the last 12 months; early persistent AF: AF episodes lasting longer than 7 days, including episodes that are terminated by cardioversion, either with drugs or by direct current cardioversion, after 7 days or more. Early persistent AF in this trial is defined as persistent AF with first-time electrical cardioversion (ECV) or a maximum of 1 previous ECVs.)

Who cannot join

  • General exclusion criteria
  • Age ≥75 years
  • History of type 1 or 2 diabetes (history of gestational diabetes is allowed)
  • Known or suspected hypersensitivity to study medication or related products
  • Treatment with GLP-1 receptor agonists within the last 3 months before randomisation
  • Treatment with dipeptidyl peptidase-4 (DPP-4) inhibitors
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  • Alcohol/drug abuse
  • Pregnant or breastfeeding women
  • Fertile women not using chemical (tablet/pill, depot injection of progesterone, sub- dermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
  • Active malignancy, unless in complete remission for ≥5 years
  • Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
  • Personal history of non-familial medullary thyroid carcinoma
  • Inflammatory bowel diseases
  • Acute or chronic pancreatitis
  • Obesity induced by other endocrinologic disorders (e.g. Cushing's Syndrome)
  • Current history of treatment with medications that may cause significant weight gain, within the last 3 months before screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g. imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium)
  • Diet attempts using herbal supplements or over-the-counter medications within 3 months before screening
  • Current participation (or within the last 3 months) in an organised weight reduction programme or currently using or used within 3 months before screening: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phentermine (either by prescription or as part of a clinical trial)
  • Severe chronic obstructive pulmonary disease
  • Uncontrolled treated/untreated hypertension (systolic >180 mmHg and/or diastolic >105 mmHg)
  • Previous or planned surgical treatment for obesity
  • Life expectancy <2.5 years
  • Other concomitant disease or treatment that according to the investigator's assessment makes the subject unsuitable for study participation
  • Participation in any other clinical intervention trial
  • Previous participation in the SOCRATES-AF pilot study
  • Inability to sign informed consent
  • Previous or planned AF ablation
  • Previous use of continuous prophylactic class I or III antiarrhythmic drugs
  • Long-standing persistent or permanent AF
  • Overall clinical history of persistent AF ≥5 years
  • ECG suggestive of malignant ventricular arrhythmia
  • Prolonged corrected QT-interval (>500 ms), unless caused by bundle branch block
  • Myocardial infarction (MI) within the last 3 months before screening
  • Coronary revascularization within the last 3 months before screening
  • Planned coronary revascularisation
  • Cardiac surgery within the last 12 months before screening
  • Obstructive hypertrophic cardiomyopathy
  • Clinically significant valvular heart disease
  • Left ventricular (LV) dysfunction (HFrEF with left ventricular ejection fraction (LVEF) <45%) unless elicited by AF
  • Hospitalization due to decompensated heart disease within 30 days prior to randomization
  • Congestive heart failure (NYHA class IV)
  • Current myocardial or pericardial infection
  • Permanent pacemaker (PM) in use or implantable cardioverter defibrillator (ICD)
  • Patient cannot be prescribed non-vitamin K oral anticoagulant (NOAC)
  • perform physical exercise for medical or personal reasons
  • Liver disease with increased plasma alanine aminotransferase (ALAT) levels of more than three times the upper limit of normal
  • Renal dysfunction (eGFR <30 ml/min), dialysis or kidney transplant
  • Clinically manifest thyroid dysfunction requiring therapy. After successful treatment of thyroid dysfunction, subjects may be enrolled, when thyroid function is controlled.
  • HbA1c >6.5% measured at screening

About this study

Official title: Semaglutide for the Reduction of Arrhythmia Burden in Overweight and Obese Patients With Atrial Fibrillation (Pilot Study)

The purpose of this pilot study is to assess the feasibility of a double-blind, randomized placebo-controlled trial of semaglutide 2.4 mg subcutaneously once weekly on top of standard care compared to standard care alone.

Read the detailed description

The SOCRATES-AF pilot study is a prospective, parallel-group, double-blind, randomized controlled trial in patients with paroxysmal or early persistent atrial fibrillation and overweight and obesity.

The primary objective is to assess the feasibility of a double-blind, randomized placebo-controlled trial of semaglutide 2.4 mg subcutaneously (s.c.) once weekly on top of current standard care (lifestyle and risk factor management, oral anticoagulant and rate control therapy) versus current standard care alone in overweight or obese patients with symptomatic paroxysmal or early persistent AF.

To assess recurrences of atrial fibrillation all participants will receive an implantable cardiac monitor.

Being tested
Semaglutide Injectable Product, Placebo
Keywords
Atrial fibrillation, Overweight, Obesity, Semaglutide, Glucagon-like peptide-1 (GLP-1) receptor agonist, Implantable cardiac monitor
Medical subject headings
Atrial Fibrillation, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semaglutide Injectable ProductDrug

    Also called Semaglutide plus lifestyle and cardiovascular risk factor management

    Subcutaneous injection of Semaglutide 2.4 mg once weekly

  • PlaceboDrug

    Also called Lifestyle and risk factor management alone

    Subcutaneous injection of volume-matched placebo once weekly

Study groups in NCT04885634
Study groupRoleWhat they receive
Intervention groupActive comparatorSemaglutide 2.4 mg subcutaneously once weekly in addition to standard AF care with lifestyle and risk factor management focusing on cardiovascular risk reduction
Receives: Drug: Semaglutide Injectable Product
Control groupPlacebo comparatorPlacebo treatment with volume-matched placebo s.c. once weekly in addition to standard AF care with lifestyle and risk factor management focusing on cardiovascular risk reduction
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants to Complete Recruitment

    Recruit 100 patients at an average recruitment rate of 2 patients per centre per month

    Measured: Up to 68 weeks, until end of treatment

  2. Number of Participants to Complete Follow-up

    Achieve complete follow-up on 90% or more of patients

    Measured: Up to 75 weeks, until final follow-up

  3. Total Resource Requirement

    Determine the resource requirements, i.e. primarily time spent per included patient, to achieve the recruitment and follow-up goals

    Measured: Up to 75 weeks, until final follow-up

Secondary outcomes (2)

  1. Efficacy of Semaglutide in Reducing AF Recurrences in Obese AF Patients

    Collect preliminary information on the effect of semaglutide 2.4 mg s.c. once weekly on top of standard care on reducing AF recurrences in obese subjects with symptomatic paroxysmal or early persistent atrial fibrillation

    Measured: Up to 75 weeks, until final follow-up

  2. Incidence of adverse effects of Semaglutide in overweight and obese AF patients

    Collect preliminary information on adverse drug effects, which may lead to discontinuation or dose reduction

    Measured: Up to 75 weeks, until final follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2021
  2. Study startOct 2022 (estimated)
  3. Primary completionJan 2024 (estimated)
  4. Study completionNov 2024 (estimated)

Why it stopped: Not received funding.

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Investigator-driven, prospective, parallel-group, double-blind, randomized controlled clinical trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04885634
Sponsor's protocol ID
2021-SOCRATES-AF
Other IDs
2021-002017-34
Acronym
SOCRATES-AF
Status last verified
Nov 2023
First submitted
10 May 2021
Last updated
3 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Semaglutide Injectable Product in people with Atrial Fibrillation and Overweight and Obesity, run by Axel Brandes.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants to Complete Recruitment (time frame: Up to 68 weeks, until end of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04885634.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.

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