What is Acromegaly?
Acromegaly is typically caused by a growth hormone (GH) secreting tumor in the pituitary. Excess GH secretion gradually results in excess production of insulin-like growth factor-1 (IGF-1) from the liver, which gradually causes bone overgrowth, organ enlargement, and changes in glucose and lipid metabolism. Symptoms of acromegaly include:1
- Abnormal growth of hands and feet
- Alteration of facial features and enlargement of lips, nose, and tongue
- Excessive sweating
- Fatigue and muscle weakness
- Joint pain
- Impaired vision
- Sleep apnea
- Enlargement of heart, liver, and other organs
1https://www.mayoclinic.org/diseases-conditions/acromegaly/symptoms-causes/syc-20351222. Accessed April 29, 2019
What is a Clinical Trial?
A clinical trial is a type of research that studies a test or treatment given to people. Clinical trials study how safe and helpful tests and treatments are. When found to be safe and helpful, they may become tomorrow’s standard of care. Clinical trials can study many things, such as:
- New drugs not yet approved by health authorities such as the U.S. Food and Drug Administration (FDA),
- New uses of drugs already approved by health authorities,
- New ways to give drugs, such as in pill form,
- Use of alternative medicines, such as herbs and vitamins,
- New tests to find and track disease, and
- Drugs or procedures that relieve symptoms.
Source: National Comprehensive Cancer Network https://www.nccn.org/patients/resources/clinical_trials/explanation.aspx
Can I Participate?
Key Eligibility Criteria
• Adults 18 to 75 years old
• Diagnosis of acromegaly
• Currently receiving octreotide, lanreotide, or pasireotide
Additional Eligibility for ACROBAT EVOLVE:
Acromegaly that is controlled (IGF-1 ≤ULN) on a stable, approved dose of octreotide LAR or lanreotide depot*
Additional Eligibility for ACROBAT EDGE:
Acromegaly with a partial or complete response to SSA-based therapy regimens, including octreotide LAR (Sandostatin LAR®), lanreotide depot (Somatuline Depot®), and pasireotide (Signifor® LAR)*
How Long is the Study?
Each of the ACROBAT Studies is up to 23 weeks.
What Can I Expect From This Study?
- All study-related care at no charge
- Regular visits with the study team
- An opportunity to advance medical science for acromegaly
What is the Purpose of the Acrobat Study?
The ACROBAT Studies are evaluating paltusotine (also known as CRN00808), an oral, non-peptide, once-daily somatostatin agonist being evaluated as an alternative to SSA injection therapy for acromegaly.