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ACTH Receptor Antagonist
CRN04894 for Cushing's Syndrome
Phase 1 & 2
Recruiting
Research Sponsored by Crinetics Pharmaceuticals Inc.
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 up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will study a new drug to treat Cushing's Syndrome, a hormone disorder, to see if it is safe and effective.
Who is the study for?
This trial is for adults aged 18-75 with active ACTH-dependent Cushing's syndrome, vaccinated against COVID-19. Participants on short-term steroid inhibitors can join after a washout period. It excludes pregnant or lactating women, those with certain pituitary issues, recent unsuccessful surgery for Cushing's, and anyone with known cancer or extremely high urine cortisol levels.
What is being tested?
The study tests CRN04894 in people with Cushing's syndrome to see how safe it is and how the body processes it. This drug blocks the action of ACTH which causes overproduction of cortisol. The trial involves increasing doses to find out what amount works best without being harmful.
What are the potential side effects?
Potential side effects aren't specified but may include reactions related to lowering cortisol production too much such as fatigue, nausea, dizziness or potentially affecting other hormones regulated by ACTH.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Multiple Ascending DosesExperimental Treatment1 Intervention
Sequential, open-label, 10-day fixed-dose cohorts.
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Who is running the clinical trial?
Crinetics Pharmaceuticals Inc.Lead Sponsor
11 Previous Clinical Trials
593 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding.I had surgery for Cushing's syndrome that didn't work within the last 6 weeks.I have had both of my adrenal glands removed.I have been diagnosed with another type of cancer.I am currently taking mitotane.I am between 18 and 75 years old.I have been diagnosed with active Cushing's syndrome recently.I have Cushing's syndrome and can stop my current medication for 14 days if needed.
Research Study Groups:
This trial has the following groups:- Group 1: Multiple Ascending Doses
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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