Recruiting
Phase 2

Tirzepatide

Sponsor:

Alaa Sada

Code:

NCT07573163

Conditions

Mild Autonomous Cortisol Secretion (MACS)

Adrenalectomy; Status

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Standard medical treatment

Study Details

Brief summary:

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.

Conditions

Mild Autonomous Cortisol Secretion (MACS)

Adrenalectomy; Status

Study ID

NCT07573163

Start date

Jul 27, 2026

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: GLP-1 Treatment

GLP-1 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.

active comparator: Standard of Care arm

Participants in this arm will receive standard of care management for as determined by their treating clinician.

Interventions

Tirzepatide

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

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

Primary outcome measure

  • Change in systolic blood pressure [ Time Frame: Baseline and 12 months ]

Central Contacts and Locations

Central contacts

Meghan Kelley

4125789429hilkoml@upmc.edu

Locations

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

More Information

Sponsor

Alaa Sada

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • adrenalectomy
  • MACS
  • mild autonomous cortisol secretion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alaa Sada on 2026-07-30.