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TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation
Plain-language guide to NCT06802081: phase 2 randomized trial of Tirzepatide, 100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06802081
- Phase
- phase 2
- Status
- recruiting participants
- Start
- 2025-04-08
- Completion (planned or actual)
- 2026-12-31
- Participants
- 100 (estimated)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Atrial Fibrillation; Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Tirzepatide.
This is a single center randomized double blind controlled study of patients (BMI ≥ 27 kg/m2) with obesity and Atrial Fibrillation (AFIB) randomized to Tirzepatide vs. placebo.
It had two arms (groups): Tirzepatide (experimental) and Control (placebo comparator).
The registry classes the interventions as drug.
More on the Plan
The obesity epidemic and all its comorbidities such as hypertension, diabetes and sleep apnea are potent risk factors for AFIB.
Weight loss has emerged as a potent treatment for AFIB.
AFIB burden will be assessed through FDA approved event monitor.
Who Took Part
The registry lists 100 planned participants were the target.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Sinus rhythm at randomization. Sustained normal sinus rhythm (or). Normal sinus rhythm at office visit. Age ≥18 to ≤80 years old. BMI ≥ 27 and ≤60 kg/m2.
The full record lists 12 inclusion and 25 exclusion criteria; among the exclusions: AFIB ablation within the last 6 months; planned ablation prior to 3 months post randomization; severe uncompensated cardiopulmonary disease.
How the Study Was Run
The set-up was randomized, parallel-group and triple-blind.
Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.
The Tirzepatide group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Tirzepatide, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2025-04-08 with completion listed for 2026-12-31.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: AFib burden (time frame: Up to 4 weeks).
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Tirzepatide in 100 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Tirzepatide compound page, all human trials.
Our Notes on the Compound
Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.