Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Avexitide · 1 trial · 1 indication
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
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
Incidence of ADAb, assessed during the Double-Blind study treatment period
| Arm | Type | Description |
|---|---|---|
| AVEXITIDE | EXPERIMENTAL | Avexitide (90 mg via subcutaneous \[SC\] injection) will be taken once per day, in the morning at least 60 minutes before the morning meal, through the duration of the treatment and OLE periods. |
| PLACEBO | PLACEBO_COMPARATOR | Placebo will be taken once per day, via subcutaneous \[SC\] injection, in the morning at least 60 minutes before the morning meal, through the duration of the treatment period. Participants receiving Placebo in the double-blind treatment period will transition to Avexitide 90 mg (via subcutaneous \[SC\] injection) in the open-label extension (OLE) period. |
| Name | Type | Description |
|---|---|---|
| Avexitide | DRUG | 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 |
| Placebo | OTHER | Matching placebo comparator |
Inclusion Criteria: * Able to provide written informed consent and understand the purpose and risks of the study * Willing and able to adhere to study requirements, including the use of the study-provided CGM device, SMBG device, and eDiary device as well as the other study evaluations and procedur...
Avexitide is an investigational small molecule being developed for the treatment of Post Bariatric Hypoglycemia, a condition of low blood sugar that can occur after bariatric surgery. It is currently in Phase 3 clinical development.
Avexitide is being developed by Amylyx Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol AMLX.
Avexitide is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. It has received Breakthrough Therapy, Rare Pediatric Disease, and Orphan Drug designations from the FDA.
Avexitide is being studied in a Phase 3 clinical trial with the identifier NCT06747468. This trial is active but not recruiting, with an estimated enrollment of 75 participants in the United States. The study is randomized, double-blind, and placebo-controlled.
Avexitide is classified as a small molecule with a target class described as '-tide (peptide)'. This classification indicates it is related to peptide-based therapies, though it is specifically a small molecule.