The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison to placebo at week 36.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
119
IM injection, a 12-week extended-release formulation of octreotide
IM injection of mannitol suspension
Double-blind Period: Percentage of Participants With IGF-1 ≤1x ULN
Time frame: 36 Weeks
Arm C: Percentage of Participants With IGF-1 ≤1x ULN
Time frame: 36 Weeks
Percent Change From Baseline in IGF-1 Values
Time frame: Up to 108 Weeks
Percentage of Participants With IGF-1 ≤1x ULN
Time frame: Up to 108 Weeks
Percentage of Participants With Growth Hormone (GH) Level <1 ng/mL
Time frame: Up to 108 Weeks
Double-blind Period: Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to 36 Weeks
Percentage of Participants Who Experienced at Least One TEAE
Time frame: Up to 113 Weeks
Local Tolerability of Debio 4126 as Assessed by Erythema, Swelling, and Induration at the Injection Site Using Investigator Assessment
Time frame: Up to 108 Weeks
Local Tolerability of Debio 4126 as Assessed by Pain at Injection Site Based on Pain Visual Analog Scale (VAS) Score
Time frame: Up to 108 Weeks
Double-blind Period: Percentage of Participants Taking Rescue Medication
Time frame: Up to 36 Weeks
Trough Plasma Concentration (Ctrough) of Debio 4126
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cedars Sinai Medical Center
Los Angeles, California, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGHarvard Medical School
Boston, Massachusetts, United States
RECRUITINGWashington University-School of Medicine
St Louis, Missouri, United States
RECRUITINGPalm Research Center Inc
Las Vegas, Nevada, United States
RECRUITINGNYU Grossman School of Medicine
New York, New York, United States
NOT_YET_RECRUITINGThe Cleveland Clinic
Cleveland, Ohio, United States
RECRUITINGThe Ohio State University
Columbus, Ohio, United States
RECRUITINGOregon Health & Science University
Portland, Oregon, United States
RECRUITINGThomas Jefferson University
Philadelphia, Pennsylvania, United States
RECRUITING...and 63 more locations
Time frame: Up to 96 Weeks