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Completed

NCT Number: NCT02772718

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

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

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Key information

Conditions

Hypoglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aurora, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XOMA 358 single dose level A

Drug

XOMA 358 single dose level A administered by intravenous infusion

XOMA 358 single dose level B

Drug

XOMA 358 single dose level B administered by an intravenous infusion

XOMA 358 single dose level C

Drug

XOMA 358 single dose level C administered by an intravenous infusion

XOMA 358 multiple dose level 1

Drug

XOMA 358 multiple dose level 1 administered by an intravenous infusion

Primary outcomes

  1. 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

  2. Single dose Part 1 - Change from baseline in glucose levels

    Time frame: Baseline and 22 days

    Glucose measured using a continuous glucose monitor

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

XOMA (US) LLC

Industry

Registry information

Acronym: XOMA 358

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
May 13, 2016
Registry last updated
May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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