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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 day 15
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 day 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 15
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of the maximum observed plasma concentration of CRN04894
Assessment of the plasma area under the curve of CRN04894
Assessment of the time to achieve maximum observed plasma concentration of CRN04894
+3 moreSecondary outcome measures
Change from baseline in early morning serum cortisol
Trial Design
1Treatment groups
Experimental Treatment
Group I: Multiple Ascending DosesExperimental Treatment1 Intervention
Sequential, open-label, 10-day fixed-dose cohorts.
Find a Location
Who is running the clinical trial?
Crinetics Pharmaceuticals Inc.Lead Sponsor
11 Previous Clinical Trials
593 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do I qualify to partake in this experiment?
"In order to be eligible for this study, individuals should possess a confirmed diagnosis of cushing syndrome and fall within the 18-75 age bracket. Approximately 18 volunteer participants are being sought after."
Answered by AI
Can octogenarians partake in this research endeavor?
"The medical trial necessitates that individuals aged between 18 and 75 meet qualification criteria. There are 388 trials specifically for underage patients, while 1013 studies focus on those above the age of 65."
Answered by AI
How many participants are being accepted for this research program?
"Affirmative. According to clinicaltrials.gov, the medical trial that was first posted on April 1st 2023 is currently recruiting participants with 18 patients being sought after at single site."
Answered by AI
Is there currently an opportunity for individuals to join this research endeavor?
"According to information on clinicaltrials.gov, the enrollment process for this research is open and ongoing; it was initially posted April 1st 2023 and most recently updated March 27th 2023."
Answered by AI
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