Clinical trial

Tirzepatide Following Adrenalectomy in Mild Autonomous Cortisol Secretion

Recruiting now · Phase 2 · 1 countries · Registry ID NCT07573163

Recruiting nowPhase 2Interventional

What this study is about

Mild Autonomous Cortisol Secretion (MACS) is a condition in which an adrenal gland produces excess cortisol and is associated with high blood pressure, diabetes, and weight gain. Surgical removal of the adrenal gland (adrenalectomy) is standard treatment, but some patients continue to have metabolic health problems after surgery. This randomized study will evaluate whether treatment with tirzepatide after adrenalectomy improves metabolic outcomes in patients with MACS compared with adrenalectomy alone.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionMild Autonomous Cortisol Secretion (MACS), Adrenalectomy; Status

Full registry criteria

Inclusion Criteria: * Adults aged 18 years and older * Diagnosis of MACS, defined as morning cortisol \>1.8 mcg/dL after a 1 mg dexamethasone suppression test * Elevated blood pressure (SBP ≥120 mmHg or DBP ≥80 mmHg per the 2025 American College of Cardiology/American Heart Association \[ACC/AHA\] criteria, or current use of antihypertensive medication) * BMI ≥27 * Undergoing or having undergone adrenalectomy for the treatment of MACS Exclusion Criteria: * Bilateral adrenal lesions * Adrenal malignancy * Concurrent primary aldosteronism with MACS * Current use of GLP-1 receptor agonists * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) * Pregnancy or breastfeeding

Treatments and study arms

Tirzepatide

Drug

Tirzepatide will be initiated at the lowest dose of 2.5 mg once weekly for 4 weeks. The dose will then be titrated every 4 weeks based on patient tolerance to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg.

Standard medical treatment

Other

Participants will receive postoperative care and follow up per institutional standard-of-care practices

Primary outcomes

Change in systolic blood pressureBaseline and 12 months

Changes in blood pressure will be assessed based on patients' average blood pressure readings, mmHg

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Pittsburgh Medical Center🇺🇸 Pittsburgh, Pennsylvania, United States