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

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

Study Overview

• Status: Completed
• Conditions: Hypoglycemia
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States
  • Illinois
    • Chicago, Illinois, United States
  • Maryland
    • Baltimore, Maryland, United States
  • Massachusetts
    • Boston, Massachusetts, United States
  • Minnesota
    • Rochester, Minnesota, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Part 1 - single dose; Cohorts A, B, and C	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	Drug: XOMA 358 multiple dose level 1; XOMA 358 multiple dose level 1 administered by an intravenous infusion

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: XOMA (US) LLC

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ACTUAL): May 1, 2021
• Study Completion (ACTUAL): May 1, 2021

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (ESTIMATE): May 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 19, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Hypoglycemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: X358603