Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
NCT07922148, Phase 2, Not yet recruiting, Beckey Trinh
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study | ClinicalTrials.gov |
| NCT number | NCT07922148 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 44 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beckey Trinh | ClinicalTrials.gov |
| Conditions | Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2) | ClinicalTrials.gov |
| Interventions | Osilodrostat (Isturisa), Placebo, hydrocortisone 10mg, Placebo (for hydrocortisone) | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from baseline in HbA1c at week 12 | Baseline and week 12 | Between-group difference in HbA1c change (%). Time Frame: Baseline and week 12 | ClinicalTrials.gov |
| Secondary | CGM Time in Range (3.9-10.0 mmol/L, %) | baseline, week 6 and week 12 | 14-day windows preceding baseline, week 6 and week 12. | ClinicalTrials.gov |
| Secondary | CGM Time in Tight Range (3.9-7.8 mmol/L, %) | baseline, week 6 and week 12 | 14-day windows preceding baseline, week 6 and week 12. | ClinicalTrials.gov |
| Secondary | CGM Time below range (<3.9 and <3.0 mmol/L, %) | baseline, week 6 and week 12 | 14-day windows preceding baseline, week 6 and week 12 | ClinicalTrials.gov |
| Secondary | CGM Time above range (>10.0 and >13.9 mmol/L, %) | baseline, week 6 and week 12 | 14-day windows preceding baseline, week 6 and week 12. | ClinicalTrials.gov |
| Secondary | Change in blood pressure | Baseline and week 12 | ClinicalTrials.gov | |
| Secondary | Change in lipid profile | Baseline and week 12 | ClinicalTrials.gov | |
| Secondary | Change in body weight and waist/hip circumference | Baseline and week 12 | ClinicalTrials.gov | |
| Secondary | Change in DXA-derived body composition | Baseline and week 12 | ClinicalTrials.gov | |
| Secondary | Proportion of participants requiring reduction of hypoglycemia-causing therapy (insulin/sulfonylurea) | Baseline to week 12 | ClinicalTrials.gov | |
| Secondary | Change in antihypertensive medication | Baseline to week 12 | ClinicalTrials.gov | |
| Secondary | Change in plasma cortisol | Baseline and week 12 | ClinicalTrials.gov | |
| Secondary | Change in salivary cortisol | Baseline to week 12 | ClinicalTrials.gov | |
| Secondary | Change in 24-h urinary cortisol | Baseline and week 12 | ClinicalTrials.gov | |
| Secondary | Change from baseline in health-related quality of life (SF-36) | Baseline and week 12 | 8 subscales + physical/mental component summaries, 0-100, higher = better | ClinicalTrials.gov |
| Secondary | Change from baseline in disease-specific quality of life (CushingQoL questionnaire) | Baseline and week 12 | higher = better | ClinicalTrials.gov |
| Secondary | Change from baseline in sleep quality (Pittsburgh Sleep Quality Index, PSQI) | Baseline and week 12 | global score 0-21, higher = worse sleep | ClinicalTrials.gov |
| Other | Change from baseline in bone mineral density by DXA (g/cm²) | Baseline and week 12 | ClinicalTrials.gov | |
| Other | Change from baseline in serum β-CTX (C-terminal telopeptide of type I collagen) | Baseline and week 12 | ClinicalTrials.gov | |
| Other | Change from baseline in serum P1NP (procollagen type I N-terminal propeptide) | Baseline and week 12 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 37318239 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)