NCT06747468Phase 3Active not recruiting

Avexitide for Treatment of Post-Bariatric Hypoglycemia

Study sponsor: Amylyx Pharmaceuticals Inc. · AMLX

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2026-07-08Actual

Enrollment · participants75Estimated

Source updated2026-08-24Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-08-24 · 2 fields changed

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~Mar 2026~~

+ After

8 Jul 2026

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Posted 2026-03-04 · 1 field changed

Recruitment status changed

− Before

~~Recruiting~~

+ After

Active not recruiting

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Study details

Conditions studied

Post Bariatric Hypoglycemia

Treatments or interventions studied

AvexitideDrugAlso known as exendin 9-39

Primary outcomes · main study measures

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measure: Composite rate of Level 2 and Level 3 hypoglycemic events; description: 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; timeFrame: During the double-blind treatment period (approximately 16 weeks); measure: Safety and Tolerability of avexitide; description: 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; timeFrame: During the double-blind treatment period (approximately 16 weeks); measure: Incidence of anti-drug antibodies (ADAb); description: Incidence of ADAb, assessed during the Double-Blind study treatment period; timeFrame: During the double-blind treatment period (approximately 16 weeks)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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