“A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ATR-101 for the Treatment of Cushing’s Syndrome” is a study for adults with Cushing’s Syndrome and is sponsored by Millendo Therapeutics, Inc. This study will evaluate the efficacy and safety of ATR-101 which is an oral study medication for the treatment of endogenous Cushing’s syndrome. The study will follow patients for up to 20 weeks including a screening period of up to 8 weeks, 6-week open-label treatment with increasing doses of study medication, 4-week double-blinded withdrawal period with study medication or placebo, and a 2 week follow-up period.
Patients should meet the following requirements to participate:
- Confirmed diagnosis of endogenous Cushing’s syndrome with elevated urinary free cortisol
- BMI 18-45 kg/m2
- If previous pituitary surgery, patients must be at least 6 months since surgery at the time of screening
- Radiotherapy within 1 year prior to or during the screening period is excluded
- Patients who are eligible for surgical treatment of Cushing’s syndrome are excluded, unless surgery is not anticipated to occur during the study
Further information is available at clinicaltrials.gov: NCT03053271