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Trial · Interventional

RecruitingPhase 2Registry data

Tirzepatide Following Adrenalectomy in Mild Autonomous Cortisol Secretion

NCTNCT07573163 (opens ClinicalTrials.gov in a new tab)Other idSTUDY25030073
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 2
Enrollment
34 participants (estimated)
Sponsor
Alaa Sada · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
27 Jul 2026
Primary completion
31 Jul 2028 (estimated)
Completion
31 Dec 2028 (estimated)
First posted
7 May 2026
Last update posted
30 Jul 2026
Conditions
Mild Autonomous Cortisol Secretion (MACS) · Adrenalectomy; Status

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. Ph 2

    Tirzepatide Following Adrenalectomy in Mild Autonomous Cortisol Secretion

    NCT07573163

    27 Jul 2026 to est. 31 Dec 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug
  • Standard medical treatmentOther

Arms2

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in systolic blood pressure

    Time frame · Baseline and 12 months

    Registry description

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

Secondary outcomes(5)

  1. weight

    Time frame · Baseline and 12 months

    Registry description

    Change in participant weight, Kg

  2. medication

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

    Registry description

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

  3. HbA1c

    Time frame · Baseline and 12 months

    Registry description

    change in HbA1c levels

  4. quality of life metrics

    Time frame · Baseline and 12 months

    Registry description

    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

    Registry description

    Any change in BMI in kg/m2

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2024

8 results

Tirzepatide and blood pressure reduction: stratified analyses of the SURMOUNT-1 randomised controlled trial.

Krumholz et al. 2024Heart (British Cardiac Society)cited by 30

PMID 39084707PMC11420724DOI 10.1136/heartjnl-2024-324170PUB-39084707

Free to read · publisher termsCC BY-NC8 results
Read at sourceSee results (8)

Indexing hint: Meta-analysis (pooled) · 2023

9 results

Effect of tirzepatide on blood pressure and lipids: A meta-analysis of randomized controlled trials.

Kanbay et al. 2023Diabetes, obesity & metabolismcited by 37

PMID 37700437DOI 10.1111/dom.15272PUB-37700437

Full text at the publisher9 results
Publisher pageSee results (9)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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