IMPACT-MACS: Adrenalectomy vs Semaglutide for Metabolic Outcomes in Mild Autonomous Cortisol Secretion
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: kidney, endocrine
- Who it enrolls
- age 18 Years to no upper limit; excludes diabetes; BMI ≥27 required; conditions: Mild Autonomous Cortisol Secretion (MACS); Autonomous Cortisol Secretion (ACS); Subclinical Cushing's; Mild Autonomous Cortisol Excess
- Interventions
- Intervention 1: Adrenalectomy; Intervention 2: Semaglutide
- Conditions
- Mild Autonomous Cortisol Secretion (MACS); Autonomous Cortisol Secretion (ACS); Subclinical Cushing's; Mild Autonomous Cortisol Excess
- Phase and size
- NA · 75 participants
- Dates
- Start 2026-03-05
Primary completion 2030-05-31 - Sponsor
- University of Texas Southwestern Medical Center (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Change in Insulin Sensitivity (M-value), mg/kg/minBaseline to Week 26
02Eligibility
Who can take part
Inclusion Criteria: * Adults ≥18 years * MACS groups: adrenal adenoma + DST cortisol \>1.8 µg/dL + no overt Cushing + eligible for adrenalectomy * Willingness to postpone surgery 6 months if randomized * Controls: no adrenal abnormalities + normal DST + BMI ≥27 + ≥2 cardiometabolic conditions * Stable medication doses for ≥4 weeks * Negative pregnancy test if applicable Exclusion Criteria: * Prior GLP-1 RA within 90 days * Weight change \>5 kg in past 90 days * Prior obesity/diabetes surgery * Type 1 diabetes or other diabetes types * Severe organ disease * Recent pancreatitis * Pregnancy, breastfeeding * Contraindication to semaglutide * Contraindication to surgery delay * Chronic glucocorticoid use
03Change log
Registry changes
No changes recorded since the trial was added.