Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia

NCT03373435 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-07-18

Study results available
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Summary

This clinical study will evaluate whether taking an investigational drug called exendin 9-39 is safe, well-tolerated, and helps to prevent low blood sugar in people who have had bariatric surgery and later develop a rare condition called postbariatric hypoglycemia (PBH).

Conditions

Interventions

DRUG

exendin 9-39

Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.

OTHER

Placebo

Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.

Sponsors & Collaborators

  • Eiger BioPharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Colleen Craig, MD · Eiger BioPharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-03-19
Primary Completion
2019-01-30
Completion
2019-03-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03373435 on ClinicalTrials.gov