34 Participants NeededMy employer runs this trial

Tirzepatide for Autonomous Cortisol Secretion

MK
Overseen ByMeghan Kelley
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether tirzepatide can improve health outcomes for individuals with Mild Autonomous Cortisol Secretion (MACS) following adrenal gland surgery. MACS can lead to high blood pressure, diabetes, and weight gain, and some individuals continue to experience these issues post-surgery. The trial compares the effects of standard care with tirzepatide treatment. Suitable candidates for this trial have undergone or will undergo adrenal gland surgery, have high blood pressure, and a BMI of 27 or higher. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using GLP-1 receptor agonists. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that tirzepatide is likely to be safe for humans?

Research shows that tirzepatide is generally well-tolerated by patients. Earlier studies associated it with improved insulin sensitivity and weight loss, which benefit those with metabolic health issues. Some side effects, such as mild stomach problems, have been reported, but they are usually manageable and tend to lessen over time. Tirzepatide is already approved for treating type 2 diabetes, indicating a certain level of safety in humans. However, since this is a Phase 2 trial, the researchers aim to further confirm its safety and effectiveness for treating mild autonomous cortisol secretion.12345

Why do researchers think this study treatment might be promising for MACS?

Unlike the standard treatments for autonomous cortisol secretion, which typically involve surgery, medications like ketoconazole, or metyrapone, tirzepatide offers a novel approach by targeting the GLP-1 receptor. This treatment is unique because it acts as a dual agonist for the GLP-1 and GIP receptors, which could help in better regulating cortisol production. Researchers are excited about tirzepatide because it not only offers a potential new mechanism of action but also provides the convenience of a once-weekly injection, which could improve patient adherence compared to daily medication regimens.

What evidence suggests that tirzepatide might be an effective treatment for MACS?

Research has shown that tirzepatide can improve metabolic health. It significantly reduces body fat and enhances insulin use, which is crucial for managing weight and blood sugar levels. For individuals with conditions like mild autonomous cortisol secretion (MACS), these benefits could address issues such as high blood pressure and diabetes. In this trial, participants in the GLP-1 Treatment arm will receive tirzepatide. Studies indicate that it improves the function of insulin-producing cells. These findings suggest that tirzepatide might effectively enhance metabolic health after adrenal gland surgery.12346

Who Is on the Research Team?

AS

Alaa Sada, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults (18+) with mild autonomous cortisol secretion who have a BMI of 27 or higher, high blood pressure, and are having or have had adrenal gland surgery. Participants must meet specific hormone test results.

Inclusion Criteria

* BMI ≥27
I have had or am having surgery to remove my adrenal gland for MACS.
I am 18 years old or older.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo unilateral adrenalectomy

1 week
1 visit (in-person)

Treatment

Participants receive tirzepatide therapy for 12 months following adrenalectomy

12 months
Monthly visits for dose adjustments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tirzepatide

Trial Overview

The study compares standard care after adrenal gland removal to adding tirzepatide, a medication that may help improve metabolism. Patients are randomly assigned to either group to see if tirzepatide offers extra benefits.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Standard of Care armActive Control1 Intervention
Group II: GLP-1 TreatmentActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alaa Sada

Lead Sponsor

Citations

Tirzepatide Following Adrenalectomy in Mild Autonomous ...

This randomized study will evaluate whether treatment with tirzepatide after adrenalectomy improves metabolic outcomes in patients with MACS compared with ...

Tirzepatide Following Adrenalectomy in Mild Autonomous ...

This randomized study will evaluate whether treatment with tirzepatide after adrenalectomy improves metabolic outcomes in patients with MACS ...

Tirzepatide for Autonomous Cortisol Secretion

This Phase 2 medical study run by Alaa Sada needs participants to evaluate whether Tirzepatide will have tolerable side effects & efficacy for patients with ...

Tirzepatide Following Adrenalectomy in Mild Autonomous ...

This randomized study will evaluate whether treatment with tirzepatide after adrenalectomy improves metabolic outcomes in patients with MACS compared with ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40600855

Randomized trial studying metabolic outcomes and quality ...

After 2 years, normalization of cortisol levels post 1 mg dexamethasone suppression test was achieved in 19/21 adrenalectomy patients compared ...

Insights into the Mechanism of Action of Tirzepatide - PMC - NIH

In addition to improved β-cell function and insulin secretion, tirzepatide treatment is also associated with improvement in insulin sensitivity.