drugset / Trial / NCT07354880

Effect of Tirzepatide on Cardiovascular and Metabolic Parameters in Obese Adult Patients With Congenital Heart Disease

NCT07354880

Phase 4 Not yet recruiting 30 enrolled University Medical Centre Ljubljana
RandomizedParallel-groupDouble-blindTreatment

Summary

Several drugs have been shown effective in the treatment of obesity, with concomitant favourable cardiovascular effects. Today, there are no studies on novel anti-obesity drugs in patients with adult congenital heart disease (ACHD). Therefore, the investigators aim to study the effects of the anti-obesity drug tirzepatide (Munjaro) on cardiovascular and metabolic factors in obese patients with ACHD. In a 24-week, randomized, open-label, placebo-controlled clinical trial the investigators will compare the effects of tirzepatide versus placebo in ACHD patients diagnosed with obesity. Patients will be randomized in a 1:1 ratio to either the intervention or placebo group. Participants will have monthly visits to monitor progress. At the beginning and end of the study, a full investigation protocol will be performed.

Timeline

Start
2026-01-20
Primary completion
2027-06-30
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tirzepatide Peptide 15 mg