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

NCT ID: NCT02771574

Last Updated: 2020-11-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Post-Bariatric Hypoglycemia (PBH) is a rare, but increasingly reported disease occurring after bariatric surgery, characterized by severe hypoglycemic episodes accompanied by symptoms of hypoglycemia. At the moment, no medical therapies have been developed for this disorder, but the clinical need is great. The major contributory factor is thought to be an exaggerated secretion of glucagon-like peptide-1 (GLP-1) due to altered nutrient transit after bariatric surgery. GLP-1 is an incretin hormone secreted primarily by the distal ileum that contributes to postprandial glucose regulation. Exendin (9-39) is a specific GLP-1 receptor antagonist, that when given via continuous IV infusion, has been shown to effectively prevent postprandial hypoglycemia and reduce symptoms of hypoglycemia in patients with PBH. This study is designed to assess the efficacy, safety and pharmacokinetic profile of a novel subcutaneous formulation of exendin (9-39).

Conditions

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Post Bariatric Hypoglycemia

Keywords

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Bariatric surgery complications Glucose Metabolism Disorders Exendin (9-39) GLP-1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Part A: Lyo avexitide 0.05 mg/kg

Participants will receive lyophilized avexitide (Lyo avexitide) twice daily for 3 days

Group Type EXPERIMENTAL

Lyo avexitide

Intervention Type DRUG

Lyophilized avexitide (Lyo avexitide) administered subcutaneously (sc)

Part A: Lyo avexitide 0.15 mg/kg

Participants will receive Lyo avexitide twice daily for 3 days

Group Type EXPERIMENTAL

Lyo avexitide

Intervention Type DRUG

Lyophilized avexitide (Lyo avexitide) administered subcutaneously (sc)

Part A: Lyo avexitide 0.35 mg/kg

Participants will receive Lyo avexitide twice daily for 3 days

Group Type EXPERIMENTAL

Lyo avexitide

Intervention Type DRUG

Lyophilized avexitide (Lyo avexitide) administered subcutaneously (sc)

Part A: Lyo avexitide 0.46 mg/kg

Participants will receive Lyo avexitide twice daily for 3 days

Group Type EXPERIMENTAL

Lyo avexitide

Intervention Type DRUG

Lyophilized avexitide (Lyo avexitide) administered subcutaneously (sc)

Part B: Liq avexitide 0.38 (±0.03) mg/kg

Participants will receive liquid avexitide (Liq avexitide) twice daily for 3 days

Group Type EXPERIMENTAL

Liq avexitide

Intervention Type DRUG

Liquid avexitide (Liq avexitide) administered subcutaneously (sc)

Interventions

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Lyo avexitide

Lyophilized avexitide (Lyo avexitide) administered subcutaneously (sc)

Intervention Type DRUG

Liq avexitide

Liquid avexitide (Liq avexitide) administered subcutaneously (sc)

Intervention Type DRUG

Other Intervention Names

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Exendin (9-39) Exendin (9-39)

Eligibility Criteria

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Inclusion Criteria

* Post-bariatric surgery more than 6 months prior to signing the informed consent
* Reported history of Whipple's triad: the occurrence of hypoglycemic symptoms associated with a capillary blood glucose of ≤55 mg/dL, and resolution with glucose or carbohydrate administration.
* Symptomatic hypoglycemia during the baseline/screening oral glucose tolerance test (OGTT), as defined by the presence of plasma glucose ≤55 mg/dL with concomitant autonomic and/or neuroglycopenic symptoms.

Exclusion Criteria

* Patients currently using sulfonylureas or other medications that may interfere with glucose metabolism within 5 half-lives of drug.
* Participation in any clinical investigation within 4 weeks prior to dosing
* History of or current insulinoma
* Active infection or significant acute illness within 2 weeks prior to dosing
* Female patients who are pregnant or lactating
* Women of childbearing potential and not utilizing effective contraceptive methods
* Inadequate end organ function
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eiger BioPharmaceuticals

INDUSTRY

Sponsor Role collaborator

Tracey McLaughlin

OTHER

Sponsor Role lead

Responsible Party

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Tracey McLaughlin

Associate Professor of Medicine (Endocrinology)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marilyn Tan, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Assistant Professor

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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Tan M, Lamendola C, Luong R, McLaughlin T, Craig C. Safety, efficacy and pharmacokinetics of repeat subcutaneous dosing of avexitide (exendin 9-39) for treatment of post-bariatric hypoglycaemia. Diabetes Obes Metab. 2020 Aug;22(8):1406-1416. doi: 10.1111/dom.14048. Epub 2020 May 4.

Reference Type RESULT
PMID: 32250530 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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36673

Identifier Type: -

Identifier Source: org_study_id