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

NCT07354880 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 0120-156/2025-2711-4
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obesity & Overweight; Adult Congenital Heart Disease

Keywords

Obesity; adult congenital heart disease; tirzepatide; cardiovascular factors; metabolic factors

Outcome Measures

Primary Outcomes (3)

• Change in exercise capacity after 6 months of treatment with tirzepatide.

  • Exercise capacity will be measured by maximum oxygen consumption at cardiopulmonary exercise testing, expressed in mL/kg/min.

  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.

  Left ventricular systolic function will be evaluated echocardiographically by global longuitudinal strain (GLS), expressed in %

  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.

  Patient's blood will be drawn between 8 and 9 am, after fasting. Cholesterol concentration will be expressed as mmol/L.

  From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).

Secondary Outcomes (3)

• Change in endothelial function after 6 months of treatment with tirzepatide.

  From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).

• Change in arterial stiffness after 6 months of treatment with tirzepatide.

  From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).

• Change in body weight after 6 months of treatment with tirzepatide.

  From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).

Other Outcomes (3)

• Change of quality of life after 6 months of treatment with tirzepatide.

  From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).

• Change of anxiety and depression after 6 months of treatment with tirzepatide.

  From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).

• Change of physical activity after 6 months of treatment with tirzepatide.

  From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).

Study Arms (2)

Trizepatide

ACTIVE COMPARATOR

Tirzepatide (Munjaro), starting dose 2,5 mg subcutaneous weekly for 4 weeks, dosage increased monthly for 2.5 mg according to study protocol, based on clinical response and tolerability.

Drug: Treatment with tirzapatide

Placebo

PLACEBO COMPARATOR

Placebo 0.9% saline via identical pens administrated subcutaneous once weekly, same as active comparator, according to the same study protocol

Drug: Treatment with placebo

Interventions

Treatment with tirzapatide DRUG

Treatment with tirzepatide for 6 months, starting dosage 2,5 mg subcutaneous. Titration every 4 weeks by 2,5 mg increase, based on clinical response and tolerability of adverse effects, up to a maximum dose of 15 mg.

Trizepatide

Treatment with placebo DRUG

Treatment with palcebo for 6 months, 0.9% saline via administrated via identical pens subcutaneous once weekly, same as active comparator, according to the same study protocol.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Current treatment with sympathomimetics or sympatholytic
• Psychiatric disorders, personal history of depressive disorders or suicidal ideation
• Pregnancy or lactation, postmenopausal, amenorrhea, reliance on natural contraception methods
• Excessive alcohol consumption
• Smoking

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

MeSH Terms

Conditions

Obesity; Overweight; Heart Defects, Congenital

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Andrej Janež, Prof., MD, PhD

  University Medical Centre Ljubljana, Slovenia

  STUDY DIRECTOR

• Margarita Brida, Ass. prof., MD, PhD

  Royal Brompton Hospital, London, UK

  STUDY CHAIR

Central Study Contacts

Katja Prokšelj, Assoc. prof., MD, PhD

CONTACT

+386 1 522 85 72; katja.prokselj@kclj.si

Andrej Janež, Prof., MD. PhD

CONTACT

+ 386 1 522 35 64; andrej.janez@kclj.si

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof., senior consultant

Model Details: Randomised, placebo-controlled

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 21, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share