Incretin Therapies in Obesity-related HFpEF

Part of paid clinical trials in New York, New York.

Sponsor: Columbia University
Study ID: NCT07554638
Phase: PHASE4
Status: Recruiting

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Conditions

Heart Failure With Preserved Ejection Fraction
Heart Failure, Diastolic
Obesity

Eligibility Criteria

Sex: ALL
Age: 40 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Tirzepatide — DRUG
Glucagon-like 1 receptor agonist/glucose-dependent insulinotropic polypeptide receptor agonist

Study Details

The central hypothesis to be tested is that patients with obesity and heart failure with preserved ejection fraction (HFpEF) prescribed tirzepatide will demonstrate reductions in measured plasma volume. In conjunction with state-of-the-art body composition analysis and measures of adipokines, this will establish an important mechanism of clinical benefit and inform disease pathophysiology. To accomplish this, this study will perform a 15-month prospective cohort study in 50 patients with obesity and HFpEF who clinically qualify for treatment with tirzepatide. The investigators will serially measure plasma volume and body composition with quantitative magnetic resonance to determine changes over time with tirzepatide treatment.

Key Dates

First listed: Apr 28, 2026
Start date: Aug 7, 2026
Status verified: Aug 2026
Primary completion: Apr 30, 2029
Completion: Apr 30, 2030

Study Design

Enrollment: 50 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Tirzepatide
After a 3-month control period, participants will be prescribed tirzepatide and undergo serial plasma volume measurement and body composition analysis. Participants will be prescribed tirzepatide under the brand name Monjauro if they have diabetes, and under the brand name Zepbound if they do not have diabetes. All participants will be initiated on an initial dose of 2.5 mg injected subcutaneously in the thigh or abdomen every week on same day and at the same time.