An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.

Official Title
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An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery

Conditions
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Hypoglycemia

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1 - single dose<br>Cohorts A, B, and C | Drug: XOMA 358 single dose level A<br>* XOMA 358 single dose level A administered by intravenous infusion<br>Drug: XOMA 358 single dose level B<br>* XOMA 358 single dose level B administered by an intravenous infusion<br>Drug: XOMA 358 single dose level C<br>* XOMA 358 single dose level C administered by an intravenous infusion<br>|
| Experimental: Part 2 - multiple doses<br>Cohort 1 | Drug: XOMA 358 multiple dose level 1<br>* XOMA 358 multiple dose level 1 administered by an intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single dose Part 1 and Multiple dose Part 2 - Incidence of treatment-emergent adverse events - | Safety assessed by treatment-emergent adverse events | 42 days | 
| Single dose Part 1 - Change from baseline in glucose levels | Glucose measured using a continuous glucose monitor | Baseline and 22 days | 
| Single dose Part 1 - Blood glucose levels | Assessment of blood glucose with a bedside meter at multiple time points specified in the protocol | Daily through Day 11 and at Day 22 | 
| Multiple dose Part 2 - Change from baseline of duration of glucose by CGM at various levels as specified in the protocol | Glucose measured by continuous glucose monitoring every 5 min | 28 days | 
| 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 |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoglycemia