← Back to Search

Steroidogenesis Inhibitor

Levoketoconazole DL3 for Cushing's syndrome (SONICS Trial)

Phase 3
Waitlist Available
Research Sponsored by Cortendo AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months of maintenance phase therapy without a prior dose increase during that phase
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

The primary objectives of this study are to evaluate the clinical responder rate, defined as the proportion of subjects with normal UFC after 6 months of treatment with COR-003 in the Maintenance Phase without dose increase, and to evaluate the range of effective doses in subjects with various levels of hypercortisolism.

Eligible Conditions
  • Cushing's syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months of maintenance phase therapy without a prior dose increase during that phase
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months of maintenance phase therapy without a prior dose increase during that phase for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cushing Syndrome

Side effects data

From 2020 Phase 3 trial • 84 Patients • NCT03277690
14%
Hypertension
9%
Fatigue
9%
Nausea
9%
Headache
5%
Vomiting
5%
Pyrexia
5%
Decreased appetite
5%
Hypercholesterolaemia
5%
Hypokalaemia
5%
Paraesthesia
5%
Cystitis
5%
Tonsillitis
5%
Depression
5%
Tachycardia paroxysmal
5%
Dry skin
5%
Adrenal insufficiency
5%
Wrist fracture
5%
Ovarian cyst
5%
Hypokalemia
5%
Constipation
5%
Diarrhoea
5%
Dyspepsia
5%
Gastroenteritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levoketoconazole-ITT RW Phase
Placebo- ITT RW Phase
Safety Population

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

8Treatment groups
Experimental Treatment
Group I: Levoketoconazole DL7Experimental Treatment1 Intervention
Levoketoconazole Tablets Dose Level 7 Twice Daily
Group II: Levoketoconazole DL6Experimental Treatment1 Intervention
Levoketoconazole Tablets Dose Level 6 Twice Daily
Group III: Levoketoconazole DL5Experimental Treatment1 Intervention
Levoketoconazole Tablets Dose Level 5 Twice Daily
Group IV: Levoketoconazole DL4Experimental Treatment1 Intervention
Levoketoconazole Tablets Dose Level 4 Twice Daily
Group V: Levoketoconazole DL3Experimental Treatment1 Intervention
Levoketoconazole Tablets Dose Level 3 Twice Daily
Group VI: Levoketoconazole DL2Experimental Treatment1 Intervention
Levoketoconazole Tablets Dose Level 1 Twice Daily
Group VII: Levoketoconazole DL1Experimental Treatment1 Intervention
Levoketoconazole Tablets Dose Level 1 Twice Daily
Group VIII: Levoketoconazole DL0Experimental Treatment1 Intervention
Levoketoconazole Tablets Dose Level 0 Once Daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levoketoconazole
FDA approved

Find a Location

Who is running the clinical trial?

Cortendo ABLead Sponsor
5 Previous Clinical Trials
223 Total Patients Enrolled
Fredric J Cohen, MDStudy DirectorCortendo AB
~8 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top