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
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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
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
RECRUITINGMedical University Graz
Graz, Austria
RECRUITING...and 60 more locations
Time frame: Up to 96 Weeks