Clinical Trial Radar

Change in Insulin Sensitivity (M-value), mg/kg/min

Hyperinsulinemic-euglycemic clamp

Baseline to Week 26

Change in fasting plasma glucose, mg/dL

Baseline to Week 26

Change in hemoglobin A1C, %

fasting blood test

Baseline to Week 26

Change in fasting insulin, µU/mL

Fasting blood test

Baseline to Week 26

Change in glucagon, pg/mL

Fasting blood test

Baseline to Week 26

Change in c-peptide, nmol/L

Fasting blood test

Baseline to Week 26

Change in IGF-1, ng/mL

Fasting blood glucose

Baseline to Week 26

Change in IGF-II, ng/mL

Fasting blood test

Baseline to Week 26

Change in IGFBP-1, ng/mL

Fasting blood test

Baseline to Week 26

Change in leptin, ng/mL

Fasting blood glucose

Baseline to Week 26

Change in adiponectin, μg/mL

Fasting blood test

Baseline to Week 26

% of patients with normal dexamethasone suppression test, %

1-mg dexamethasone suppression test

Baseline to Week 26

Change in steroid profile, ng/24h

25-steroid profiling in the 24-hour urine, reported as aggregate

Baseline to Week 26

Mean change in systolic BP, mmHg

24-hour Ambulatory BP

Baseline to Week 26

Mean change in diastolic BP, mmHg

24-hour Ambulatory BP

Baseline to Week 26

Change in cholesterol, mg/dL

Fasting blood test

Baseline to Week 26

Change in Free Fatty Acids, mmol/L

Fasting blood test

Baseline to Week 26Baseline to Week 26

Change in C-reactive protein, pg/mL

Fasting blood test

Baseline to Week 26

Change in TNF-alpha, pg/mL

Fasting blood glucose

Baseline to Week 26

Change in Interleukin-1, pg/mL

Fasting blood test

Baseline to Week 26

Change in Interleukin-6, pg/mL

Fasting blood test

Baseline to Week 26

Change in body weight, kg

electronic scale

Baseline to Week 26

Change in BMI, kg/m2

calculated from weight and height

Baseline to Week 26

Change in waist circumference, cm

Tape measure

Baseline to Week 26

Change in fat area, cm2

Limited unenhanced CT

Baseline to Week 26

Change in muscle area, cm2

Limited unenhanced CT

Baseline to Week 26

Change in bone mineral density, mg/cm³

Limited unenhanced CT

Baseline to Week 26

Change in chair rise test, stands/30s

Time test, number of stands from chair in 30 seconds

Baseline to Week 26

Change in Hand Grip Strength, kg

Dynamometer

Baseline to Week 26

Change in overall quality of life, score

PROMIS Global Health Questionnaire, domain-specific scales; The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health v1.2 Questionnaire assesses overall health-related quality of life across multiple domains, including physical health, mental health, social functioning, fatigue, and general well-being. It yields two standardized T-score summary measures (Global Physical Health and Global Mental Health). Score Range: T-scores typically range from 20 to 80. Interpretation: Higher T-scores indicate better health-related quality of life. Assessment Method: Self-report questionnaire; estimated completion time 2-5 minutes.

Baseline to Week 26

Change in disease-specific QoL, score

Cushing Quality of Life Questionnaire (CushingQoL) Description: The Cushing Quality of Life Questionnaire (CushingQoL) is a disease-specific tool assessing health-related quality of life in individuals with hypercortisolism. It contains 12 items scored on a 5-point Likert scale. Score Range: 12 (minimum) to 60 (maximum). Interpretation: Higher scores indicate better quality of life; lower scores indicate poorer quality of life. Domains: Sleep disturbances, mood, physical appearance, social interaction, health concerns. Assessment Method: Self-administered; estimated completion time \~5 minutes.

Baseline to Week 26

Change in mood, score

PROMIS Depression Short Form \& PROMIS Anxiety Short Form Description: The PROMIS Depression Short Form and PROMIS Anxiety Short Form measure depressive and anxiety symptoms over the past seven days, assessing emotional distress, negative affect, and somatic symptoms. Responses are on a 5-point Likert scale ("Never" to "Always"), converted to standardized T-scores. Score Range: T-scores typically range from 20 to 80. Interpretation: Higher scores indicate worse depressive or anxiety symptoms. Assessment Method: Self-report questionnaires; estimated completion time 2-4 minutes each.

Baseline to Week 26

Change in cognition, seconds

Trail Making Test - Part A and Part B (TMT-A and TMT-B) Description: The Trail Making Test Parts A and B assess visual attention, processing speed, cognitive flexibility, and executive function. Part A requires sequential connection of numbers; Part B requires alternating between numbers and letters. Score Range: 0 to 300 seconds (maximum test time). Interpretation: Higher (longer) completion times indicate worse cognitive performance. Assessment Method: Performance-based timed test administered by study personnel; expected duration \~5 minutes.

Baseline to Week 26

Change in sleep, score

PROMIS Sleep Disturbance Short Form Description: The PROMIS Sleep Disturbance Short Form evaluates sleep quality, difficulty initiating and maintaining sleep, and overall sleep problems over the past seven days. Scores are converted into standardized T-scores. Score Range: T-scores typically range from 20 to 80. Interpretation: Higher scores indicate worse sleep disturbance. Assessment Method: Self-administered; estimated completion time 2-4 minutes.

Baseline to Week 26

Change in frailty, score

FRAIL Scale (Fatigue, Resistance, Ambulation, Illnesses, Loss of Weight) Description: The FRAIL Scale is a validated screening instrument assessing functional decline and physiological frailty. It consists of five yes/no items: fatigue, resistance, ambulation, illnesses, and weight loss. Score Range: 0 (minimum) to 5 (maximum). Interpretation: Higher scores indicate greater frailty. Frailty Categories: 0: Robust 1-2: Pre-frail 3-5: Frail Assessment Method: Administered by study personnel; duration \~1 minute.

Baseline to Week 26

Change in eating behavior, score

Eating Behavior and Appetite Questionnaire (EBAQ) Description: The Eating Behavior and Appetite Questionnaire (EBAQ) evaluates hunger, satiety, food cravings, and changes in appetite and eating behavior. It generates domain-specific and total scores. Score Range: Varies by version; treated as continuous scores with defined minimum and maximum values per subscale. Interpretation: Higher scores indicate greater appetite or more pronounced eating-behavior disturbances. Assessment Method: Self-administered; estimated completion time 3-5 minutes.

Baseline to Week 26

Adverse Events and Serious Adverse Events

Baseline through Week 30