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

NCT02772718 | Completed Phase 2

• 1 other identifier: X358603
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Hypoglycemia

Keywords

Hypoglycemia

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Part 1 - single dose

EXPERIMENTAL

Cohorts A, B, and C

Drug: XOMA 358 single dose level A; Drug: XOMA 358 single dose level B; Drug: XOMA 358 single dose level C

Part 2 - multiple doses

EXPERIMENTAL

Cohort 1

Drug: XOMA 358 multiple dose level 1

Interventions

XOMA 358 single dose level A DRUG

XOMA 358 single dose level A administered by intravenous infusion

Part 1 - single dose

XOMA 358 single dose level B DRUG

XOMA 358 single dose level B administered by an intravenous infusion

Part 1 - single dose

XOMA 358 single dose level C DRUG

XOMA 358 single dose level C administered by an intravenous infusion

Part 1 - single dose

XOMA 358 multiple dose level 1 DRUG

XOMA 358 multiple dose level 1 administered by an intravenous infusion

Part 2 - multiple doses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• XOMA (US) LLC: lead

Study Sites (5)

Unknown Facility

Aurora, Colorado, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Rochester, Minnesota, United States

Location

MeSH Terms

Conditions

Hypoglycemia

Interventions

XOMA 358

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Allan Gordon, MD, PhD

  XOMA (US) LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 13, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 21, 2021

Record last verified: 2021-05

Locations

US (5)