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Tirzepatide Following Adrenalectomy in Mild Autonomous Cortisol Secretion

ConditionsMild Autonomous Cortisol Secretion (MACS)Adrenalectomy; Status
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlaa Sada

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Bilateral adrenal lesions

Adrenal malignancy

Concurrent primary aldosteronism with MACS

Current use of GLP-1 receptor agonists

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: GLP-1 TreatmentActive comparator 1 intervention
Group B: Standard of Care armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in systolic blood pressure

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

Time frame
Baseline and 12 months

Secondary outcomes

1

weight

Change in participant weight, Kg

Time frame
Baseline and 12 months
2

medication

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

Time frame
Baseline and 12 months reported in WHO defined daily doses (DDDs)
3

HbA1c

change in HbA1c levels

Time frame
Baseline and 12 months
4

quality of life metrics

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.

Time frame
Baseline and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alaa Sada

Lead sponsor

University of Pittsburgh

Sponsor institution

Source ClinicalTrials.gov
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