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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).
This is a Phase 2, multicenter, randomized, single-blind, placebo-controlled cross-over study in patients with refractory PBH.
Participants will be randomized and assigned in a 1:1 ratio to one of two treatment arms. All participants will receive 2 dosing regimens of exendin 9-39 and matching placebo self-administered via subcutaneous (SC) injection.
Participants will undergo in-clinic mixed meal tolerance test (MMTT) provocation with concomitant blood draws and symptom assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Experimental | patients will receive two dose regimens of exendin 9-39 and one placebo |
|
| Treatment Group 2 | Experimental | patients will receive two dose regimens of exendin 9-39 and one placebo (in a different sequence than Treatment Group 1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exendin 9-39 | Drug | Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial Glucose Nadir | Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT) | 3 hours following a liquid meal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colleen Craig, MD | Eiger BioPharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States | ||
| University of Colorado, Denver |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33616643 | Result | Craig CM, Lawler HM, Lee CJE, Tan M, Davis DB, Tong J, Glodowski M, Rogowitz E, Karaman R, McLaughlin TL, Porter L. PREVENT: A Randomized, Placebo-controlled Crossover Trial of Avexitide for Treatment of Postbariatric Hypoglycemia. J Clin Endocrinol Metab. 2021 Jul 13;106(8):e3235-e3248. doi: 10.1210/clinem/dgab103. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group 1 | Placebo first, then exendin 9-39 30 mg BID, then exendin 9-39 60 mg QD exendin 9-39: Exendin 9-39 is a competitive antagonist of glucagon-like peptide-1 (GLP-1) at its receptor. Placebo: Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39. |
| FG001 | Treatment Group 2 | Placebo first, then exendin 9-39 60 mg QD, then exendin 9-39 30 mg BID exendin 9-39: Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor. Placebo: Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (14 Days) |
| |||||||||||||
| Treatment Period 2 (14 Days) |
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| Treatment Period 3 (14 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group 1 (Placebo, Exendin 9-39 30 mg BID, Exendin 9-39 60 mg QD) | Placebo, exendin 9-39 30 mg BID, exendin 9-39 60 mg QD exendin 9-39: Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor. Placebo: Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postprandial Glucose Nadir | Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT) | Analysis population are both treatment group 1 and treatment group 2. One participant was excluded from the efficacy analysis due to major protocol deviation. | Posted | Mean | Standard Deviation | mg/dL | 3 hours following a liquid meal |
|
3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Avexitide 30 mg BID | patients (treatment group 1 + treatment 2) received 30 mg twice a day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| presyncope | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site bruising | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior VP, Clinical Development | Eiger BioPharmaceuticals, Inc. | 1-650-272-6138 | info@eigerbio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2021 | Apr 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C083773 | exendin (9-39) |
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| Placebo | Other | Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39. |
|
| Aurora |
| Colorado |
| 80045 |
| United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Duke Early Phase Clinical Research | Durham | North Carolina | 27710 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 |
| Treatment Group 2 (Placebo, Exendin 9-39 60 mg QD, Exendin 9-39 30 mg BID) |
Placebo, exendin 9-39 60 mg QD, exendin 9-39 30 mg BID exendin 9-39: Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor. Placebo: Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| OG002 |
| Placebo |
Patients received placebo in treatment period 1 (initial 14 days) in the study. |
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 3 |
| 18 |
| EG001 | Avexitide 60 mg QD | patients (treatment group 1 + treatment group 2)) received 60 mg once a day. | 0 | 18 | 1 | 18 | 9 | 18 |
| EG002 | Placebo | Patients received placebo in treatment period 1 (initial 14 days) in the study. | 0 | 18 | 0 | 18 | 14 | 18 |
| Headache | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Injection site pain | General disorders | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
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