TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT06802081
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Weekly subcutaneous injections starting with dose 2.5mg, then increase dose by 2.5mg at week 4 (5mg), week 8 (7.5mg) and at week12 (10mg) as tolerated.
  • Placebo — DRUG
    Weekly subcutaneous injections starting with dose 2.5mg, then increase dose by 2.5mg at week 4 (5mg), week 8 (7.5mg) and at week 12 (10mg).

Study Details

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 is expected that the significant weight loss with Tirzepatide will result in improved control, management, symptom severity, and burden of AFIB at 12 months.

Key Dates

Start date
Apr 8, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
    Participants to inject weekly subcutaneous injections of Tirzepatide starting with dose 2.5mg, then increase dose by 2.5mg at week 4 (5mg), week 8 (7.5mg) and at week 12 (10mg) as tolerated.
  • Placebo Comparator: Control
    Participants to inject weekly subcutaneous injections of normal saline starting with dose 2.5mg, then increase dose by 2.5mg at week 4 (5mg), week 8 (7.5mg) and at week 12 (10mg).

Primary Outcome Measure

AFib burden [ Time Frame: Up to 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Jeannine Ramsey, RN, BSN
[email protected]
Yuki Kuramochi, RN, BSN
[email protected]
216-445-4063
Leslie Cho, MD (PRINCIPAL_INVESTIGATOR)
Arwa Younis, MD (SUB_INVESTIGATOR)
Oussama Wazni, MD (SUB_INVESTIGATOR)

Find similar trials in Cleveland, OH

By condition
Atrial fibrillationObesity / overweight
By specialty
CardiologyHeart diseaseEndocrinologyMetabolic healthWeight loss
By research site
Cleveland Clinic· Cleveland, OH

Related Studies