NCT07354880Not yet recruitingPhase 4
Effect of Tirzepatide on Cardiovascular and Metabolic Parameters in Obese Adult Patients With Congenital Heart Disease
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 9 Jan 2026
- Start date
- 20 Jan 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- University Medical Centre Ljubljana
- Diseases
- Obesity
- NCT number
- NCT07354880
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- From 20 Jan 2026 to the primary completion date, 30 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with sympathomimetics or sympatholytic
Other illness
- Down syndrome
- Type 2 diabetes
- Severe heart failure (NYHA IV), EF of systemic or subpulmonary ventricle \< 30%, malignant arrhythmias, severe heart valve disease
- Personal history of malignancy, personal or family history of medullary thyroid carcinoma
- Personal history of pancreatitis or cholelithiasis
- Personal history of acute coronary events or hemodynamically significant coronary artery disease
- Psychiatric disorders, personal history of depressive disorders or suicidal ideation
Other
- Pregnancy or lactation, postmenopausal, amenorrhea, reliance on natural contraception methods
- Excessive alcohol consumption
- Smoking
Who the study is looking for
- Obese or overweight adult patients with congenital heart disease
- BMI between 30 kg/m² and 40 kg/m²
- Prior comprehensive non-pharmacological and non-surgical management of obesity, including a history of at least 12 months of intensive lifestyle intervention with a maximum weight reduction of less than 5%
- Stable body weight within the three months preceding study enrollment (defined as weight fluctuations within 5%)
- No prior pharmacological or surgical interventions for obesity
- Euthyroid state
- Eumenorrhea or oligomenorrhea
- Ability to comprehend the study objectives and procedures
- Willingness to provide informed consent and to comply with the study protocol, including the use of highly effective contraception during the study period, with signed consent and agreement provided in duplicate
- Commitment to use highly reliable contraception and absence of plans for pregnancy within the 8 months following enrollment.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.