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An open label, long-term extension study to evaluate the safety and efficacy of CRN00808 in subjects with acromegaly (ACROBAT ADVANCE)
EU CTIS ID: 2024-511921-75-00
What this study is testing
This study is designed to evaluate the long-term safety and tolerability of paltusotine in acromegaly subjects; to evaluate the efficacy of paltusotine in acromegaly patients.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Completed one of the parent studies (Acrobat Evolve (CRN00808-02) or Acrobat Edge (CRN00808-03))
- 2. Females must be non-pregnant and non-lactating either surgically sterile, post-menopausal, or using effective method(s) of birth control.
- 3. Willing to provide signed informed consent
You likely can't join if
- 1. Clinically significant concomitant disease including, but not limited to, cardiovascular disease; moderate or severe renal insufficiency; or significant liver disease (including cirrhosis)
- 10. Subjects with clinically significant abnormal findings during the Screening Period, and any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study
- 2. Pituitary radiation since completing participation in parent studies
- 3. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 year
- 4. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab).
- 5. History of alcohol or substance abuse in the past 12 months
See the full eligibility criteria
- 1. Completed one of the parent studies (Acrobat Evolve (CRN00808-02) or Acrobat Edge (CRN00808-03))
- 2. Females must be non-pregnant and non-lactating either surgically sterile, post-menopausal, or using effective method(s) of birth control.
- 3. Willing to provide signed informed consent
- 1. Clinically significant concomitant disease including, but not limited to, cardiovascular disease; moderate or severe renal insufficiency; or significant liver disease (including cirrhosis)
- 10. Subjects with clinically significant abnormal findings during the Screening Period, and any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study
- 2. Pituitary radiation since completing participation in parent studies
- 3. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 year
- 4. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab).
- 5. History of alcohol or substance abuse in the past 12 months
- 6. Use of any investigational drug (other than paltusotine) within the past 30 days or 5 half-lives, whichever is longer before Screening
- 7. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.
- 8. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
- 9. Subjects with symptomatic cholelithiasis
The study team makes the final eligibility decision.
Where it's taking place
- Serbia
- United Kingdom
- United States
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Serbia; United Kingdom; United States; Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.