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Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia

NCT02771574 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-11-13

Study results available
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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.

Conditions

  • Post Bariatric Hypoglycemia

Interventions

DRUG

Lyo avexitide

Lyophilized avexitide (Lyo avexitide) administered subcutaneously (sc)

DRUG

Liq avexitide

Liquid avexitide (Liq avexitide) administered subcutaneously (sc)

Sponsors & Collaborators

  • Eiger BioPharmaceuticals

    collaborator INDUSTRY

  • Tracey McLaughlin

    lead OTHER

Principal Investigators

  • Marilyn Tan, MD · Clinical Assistant Professor

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-06-30
Completion
2017-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02771574 on ClinicalTrials.gov