Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as exendin 9-39
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 post bariatric hypoglycemia, a metabolic condition that can occur after bariatric surgery. It is in Phase 3 clinical development and has received Breakthrough Therapy and Orphan Drug designations from the FDA for this indication.
Avexitide is a GLP1R antagonist. It works by blocking the glucagon-like peptide-1 receptor (GLP1R), which is involved in regulating insulin secretion. By antagonizing this receptor, Avexitide aims to reduce excessive insulin release that can lead to low blood sugar in post bariatric hypoglycemia.
Avexitide is being developed by Amylyx Pharmaceuticals, Inc., which trades under the ticker AMLX. The company is responsible for its clinical development in post bariatric hypoglycemia.
Avexitide is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA. The ongoing Phase 3 trial is active but not recruiting, and no trials have been completed yet.
Avexitide is being evaluated in a Phase 3 clinical trial, NCT06747468, titled "Avexitide for Treatment of Post-Bariatric Hypoglycemia." The trial is active but not recruiting, with an estimated enrollment of 75 participants. It is randomized, double-blind, and placebo-controlled, and is being conducted in the United States.
Avexitide is the primary name for this drug. No alternative names are provided in the available information.