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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change in exercise capacity after 6 months of treatment with tirzepatide.
Timeframe: From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).
Change in left ventricular systolic function after 6 months of treatment with tirzepatide.
Timeframe: From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).
Change in cholesterol levels after 6 months of treatment with tirzepatide.
Timeframe: From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).
Katja Prokšelj, Assoc. prof., MD, PhD