CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Lyo avexitide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02771574
NCT02771574Phase 2Completed
CompareCT.gov

A Phase 2 Multi-Ascending Dose Trial to Assess the Efficacy, Tolerability and Pharmacokinetic Profile of Exendin (9-39) in Patients With Post-bariatric Hyperinsulinemic Hypoglycemia

Tracey McLaughlin·interventional·Posted May 13, 2016·Updated Nov 13, 2020

In Brief

A Phase 2 clinical trial evaluating Lyo avexitide and Liq avexitide for Post Bariatric Hypoglycemia. Completed, enrolled 19 participants across 1 site.

Detailed Summary

This study is designed to evaluate the efficacy, safety and pharmacokinetics of subcutaneous exendin (9-39) in subjects with post-bariatric hypoglycemia. Development of this subcutaneous formulation of exendin (9-39) would represent a targeted therapeutic approach for this rare disease with unmet clinical need.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Bariatric Hypoglycemia
CountriesUnited States
CollaboratorsEiger BioPharmaceuticals

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 13, 2016
Enrollment StartMay 1, 2016
Primary CompletionJun 1, 2017
TodayJul 3, 2026
Enrollment to primary: 1.1 yearsPosted 10.1 years ago

Interventions

Lyo avexitidedrug

Lyophilized avexitide (Lyo avexitide) administered subcutaneously (sc)

Liq avexitidedrug

Liquid avexitide (Liq avexitide) administered subcutaneously (sc)