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NCT Number: NCT07573163

Tirzepatide Following Adrenalectomy in Mild Autonomous Cortisol Secretion

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.

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Key information

Conditions

Mild Autonomous Cortisol Secretion (MACS) Adrenalectomy; Status

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

About this study

This prospective, randomized study will enroll adults with MACS and elevated blood pressure who are undergoing unilateral adrenalectomy. Following surgery, participants will be randomized in a 1:1 ratio to one of two groups: adrenalectomy alone or adrenalectomy followed by tirzepatide therapy for 12 months. Tirzepatide will be prescribed and managed by the study team in accordance with current standard-of-care practices, including routine clinical monitoring and dose adjustments.

The primary focus of the study is to evaluate blood pressure control at 12 months. Secondary outcomes include change in body weight, body mass index, glycemic control, medication burden, and patient-reported quality of life. This study aims to generate preliminary data on the feasibility, safety, and potential additive metabolic benefits of combining pharmacologic incretin-based therapy with surgical management of MACS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Change in systolic blood pressure

    Time frame: Baseline and 12 months

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

Secondary outcomes

  1. weight

    Time frame: Baseline and 12 months

    Change in participant weight, Kg

  2. medication

    Time frame: Baseline and 12 months reported in WHO defined daily doses (DDDs)

    any change in medication expressed as defined daily doses (DDDs)

  3. HbA1c

    Time frame: Baseline and 12 months

    change in HbA1c levels

  4. quality of life metrics

    Time frame: Baseline and 12 months

    quality of life metrics will measured using the 36-Item Short Form Health Survey (SF-36) which is a validated measure of health-related quality of life assessing eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health status. Domain scores may be analyzed individually or combined using standard scoring algorithms to generate the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, which are norm-based (mean 50, SD 10); higher values reflect better physical and mental health, respectively.

  5. BMI

    Time frame: Baseline and 12 months

    Any change in BMI in kg/m2

Study contacts

Contact information is provided by the study sponsor or research team.

Meghan Kelley

CONTACT

[email protected]

4125789429

Sponsors and collaborators

Lead sponsor

Alaa Sada

Other

Registry information

Official study title

A Randomized Clinical Trial of Tirzepatide Following Adrenalectomy in Mild Autonomous Cortisol Secretion

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 7, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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