AVX-001 (LUCIDITY) is a Phase 3 study to evaluate avexitide compared to placebo in participants with post bariatric hypoglycemia (PBH) related to Roux-en-Y gastric bypass (RYGB). The study will assess avexitide compared to placebo for safety and efficacy, measured by reduction of hypoglycemic events. The study includes a Screening period with a Run-in period (of up to 6- and 3-weeks, respectively); a randomized, double-blind, placebo-controlled study treatment period of 16 weeks; and a two-part open-label extension (OLE) period with a duration of approximately 32 weeks.
AVX-001 (LUCIDITY) is a Phase 3 multicenter study to evaluate avexitide compared to placebo in participants with post bariatric hypoglycemia (PBH) related to Roux-en-Y gastric bypass (RYGB). Eligible participants must have a confirmed diagnosis of PBH related to RYGB, must be a minimum of 1-year post-surgery, and must have experienced at least 3 discrete hypoglycemic events during the 3-week study Run-in period while adhering to consistent dietary management. The study includes a Screening period of up to 6 weeks in duration, inclusive of a 3-week Run-in period; a randomized, double-blind, placebo-controlled study treatment period of 16 weeks in duration; and a two-part open-label extension (OLE) period with a duration of 32 weeks. The Double-Blind period is designed to evaluate the efficacy and safety of 90 mg per day of avexitide (given by subcutaneous injection) compared to placebo in participants with PBH after Roux-en-Y gastric bypass (RYGB), who are not adequately controlled on dietary management for reduction of hypoglycemic events. The subsequent 32-week Open Label Extension (OLE) period is intended to further evaluate the safety and efficacy of avexitide (90 mg per day, given by subcutaneous injection) in participants who have completed the Double-Blind period. The OLE period consists of an 8-week initial Part A and a subsequent 24-week Part B. Participants will use a continuous glucose monitor (CGM) in blinded mode, a self-monitoring of blood glucose (SMBG) device (glucose meter), and an electronic diary (eDiary) on a smartphone to record hypoglycemic events and study drug administration during the screening period, 16-week double-blind period, and 8-week OLE Part A. While the CGM is in blinded mode, participants will not see their specific blood glucose values on their CGM, but they will receive an alert when their blood glucose is low; they may check their blood glucose via the SMBG glucose meter device at any time. During the 24-week OLE Part B, participants will use a CGM in unblinded mode (blood glucose values are visible to the participant) and the SMBG and eDiary devices will not be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
Avexitide (also known as exendin 9-39), a first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist, is a 31-amino acid peptide with a free amino group at the N-terminus and an amidated C-terminus. By binding to the GLP-1 receptor, avexitide inhibits GLP-1 receptor signaling, thereby reducing GLP-1 receptor-mediated insulin secretion
Matching placebo comparator
Stanford Health Care - Endocrinology Clinic
Stanford, California, United States
RECRUITINGUniversity of Colorado Health Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGEast Coast Institute for Research
Jacksonville, Florida, United States
RECRUITINGHanson Diabetes Center
Port Charlotte, Florida, United States
RECRUITINGGeorgia Clincal Research
Lawrenceville, Georgia, United States
RECRUITINGCotton-O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, United States
RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGJoslin Diabetes Center
Boston, Massachusetts, United States
RECRUITINGNYC Health + Hospitals/Queens - BRANY
New Hyde Park, New York, United States
RECRUITINGDuke Center for Metabolic and Weight Loss Surgery
Durham, North Carolina, United States
RECRUITING...and 11 more locations
Composite rate of Level 2 and Level 3 hypoglycemic events
Composite rate of Level 2 hypoglycemia (as measured by self-monitoring of blood glucose \[SMBG\]) and Level 3 hypoglycemia (per American Diabetes Association \[ADA\], European Association for the Study of Diabetes \[EASD\]; adjudicated by independent Event Adjudication Committee \[EAC\]), assessed during the Double-Blind study treatment period
Time frame: During the double-blind treatment period (approximately 16 weeks)
Safety and Tolerability of avexitide
Incidence of adverse events (AEs)-e.g., incidence of treatment-emergent AEs (TEAEs), serious AEs (SAEs), AEs of special interest (AESIs), and TEAEs leading to discontinuation-and other safety assessments (e.g., clinical laboratory results and vital sign measurements), assessed during the Double-Blind study treatment period
Time frame: During the double-blind treatment period (approximately 16 weeks)
Incidence of anti-drug antibodies (ADAb)
Incidence of ADAb, assessed during the Double-Blind study treatment period
Time frame: During the double-blind treatment period (approximately 16 weeks)
Further evaluate the efficacy of avexitide compared to placebo for reduction of hypoglycemia
Rates of the following, assessed during the Double-Blind study treatment period: * Level 2 hypoglycemia as measured by SMBG * Level 3 hypoglycemia, adjudicated by EAC * Level 2 hypoglycemia as measured by CGM
Time frame: During the double-blind treatment period (approximately 16 weeks)
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