An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery (XOMA 358)
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ClinicalTrials.gov Identifier: NCT02772718 |
Recruitment Status : Unknown
Verified February 2017 by XOMA (US) LLC.
Recruitment status was: Recruiting
First Posted : May 13, 2016
Last Update Posted : February 6, 2017
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Condition or disease | Intervention/treatment | Phase |
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Hypoglycemia | Drug: XOMA 358 single dose level A Drug: XOMA 358 single dose level B Drug: XOMA 358 single dose level C Drug: XOMA 358 multiple dose level 1 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery |
Study Start Date : | April 2016 |
Estimated Primary Completion Date : | September 2017 |
Estimated Study Completion Date : | October 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Part 1 - single dose
Cohorts A, B, and C
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Drug: XOMA 358 single dose level A
XOMA 358 single dose level A administered by intravenous infusion Drug: XOMA 358 single dose level B XOMA 358 single dose level B administered by an intravenous infusion Drug: XOMA 358 single dose level C XOMA 358 single dose level C administered by an intravenous infusion |
Experimental: Part 2 - multiple doses
Cohort 1
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Drug: XOMA 358 multiple dose level 1
XOMA 358 multiple dose level 1 administered by an intravenous infusion |
- Single dose Part 1 and Multiple dose Part 2 - Incidence of treatment-emergent adverse events - [ Time Frame: 42 days ]Safety assessed by treatment-emergent adverse events
- Single dose Part 1 - Change from baseline in glucose levels [ Time Frame: Baseline and 22 days ]Glucose measured using a continuous glucose monitor
- Single dose Part 1 - Blood glucose levels [ Time Frame: Daily through Day 11 and at Day 22 ]Assessment of blood glucose with a bedside meter at multiple time points specified in the protocol
- Multiple dose Part 2 - Change from baseline of duration of glucose by CGM at various levels as specified in the protocol [ Time Frame: 28 days ]Glucose measured by continuous glucose monitoring every 5 min
- Multiple dose Part 2 - Change from baseline of number of episodes and percent of episodes of hypoglycemia per day with glucose by CGM at various levels as defined in the protocol [ Time Frame: 28 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Aged at least 18 years of age
- Body Mass Index < 35 kg/m2 at baseline, unless discussed with Medical Monitor and patients with higher body mass index do not have significant medical co-morbidities that would confound ability to assess safety and efficacy of study drug.
- Received gastric bypass surgery more than 1 year before dosing
- Occurrence of postprandial hypoglycemia (blood glucose less than 60mg/dL) during the Baseline provocation assessments and/or by continuous glucose monitoring, as defined in the protocol.
Exclusion Criteria:
- History of type 1 diabetes
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Planned use of the following medications on or after Day -3 (Part 1):
- Any agent for hypoglycemia, such as diazoxide or octreotide
- Antihyperglycemic agents, including subcutaneous insulin therapy, sulfonylureas, SGLT2 inhibitors, and GLP-1 agonists
- Systemic glucocorticoids or β agonists that may affect glucose metabolism
- Long-acting somatostatin analogs or glucose-affecting medications
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During Part 2, the following therapies are prohibited as specified below:
- Tramadol and any other medications not used in the treatment of post-bariatric surgery hypoglycemia that may cause hypoglycemia or fluctuations in blood glucose levels.
- Acetaminophen-containing products during periods of continuous glucose monitoring.
Medications such as tramadol may cause hypoglycemia or fluctuations in blood glucose levels and, as such, use of such medications is subject to the restrictions as described above during the study. Acetaminophen can interfere with the accuracy of the glucose sensor of the continuous glucose monitoring system and is, therefore, prohibited during continuous glucose monitoring.
- Major general surgery within 3 months before study entry or anticipated during the study period
Other protocol-defined inclusion/exclusion criteria may apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772718
Contact: Ann Neale | 510-204-7515 |
United States, Colorado | |
Recruiting | |
Aurora, Colorado, United States | |
United States, Illinois | |
Not yet recruiting | |
Chicago, Illinois, United States | |
United States, Maryland | |
Recruiting | |
Baltimore, Maryland, United States | |
United States, Massachusetts | |
Recruiting | |
Boston, Massachusetts, United States | |
United States, Minnesota | |
Recruiting | |
Rochester, Minnesota, United States |
Study Director: | Allan Gordon, MD, PhD | XOMA (US) LLC |
Responsible Party: | XOMA (US) LLC |
ClinicalTrials.gov Identifier: | NCT02772718 |
Other Study ID Numbers: |
X358603 |
First Posted: | May 13, 2016 Key Record Dates |
Last Update Posted: | February 6, 2017 |
Last Verified: | February 2017 |
Hypoglycemia |
Hypoglycemia Glucose Metabolism Disorders Metabolic Diseases |
Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |