A Phase 1 interventional study of REMD-477 in Hyperglycemia Drug Induced, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-11.
Sponsored by Duke University · Phase 1, Interventional, and Treatment
REMD-477 (Volagidemab) is a human anti-glucagon receptor antibody. Its proposed mechanism of action in controlling hyperglycemia is by blocking glucagon receptor (GCGR) signaling. In this way, it increases hepatic glucose uptake, decreases hepatic glycogenolysis and gluconeogenesis, increases glycogen synthesis, and ultimately decreases blood glucose levels. This protocol will test the hypotheses that REMD-477 is safe and tolerable in patients with severe hyperglycemia on copanlisib and that it decreases the risk of severe hyperglycemia in patients receiving copanlisib for relapsed refractory lymphoma
699 studies on the registry are indexed under Hyperglycemia; 105 are open to participants now.
This study's enrollment of 1 is below the median of 46 across 521 interventional studies indexed under Hyperglycemia.
Browse Hyperglycemia studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
REMD-477 (human IgG2 anti-glucagon receptor antibody Volagidemab) will be administered as a subcutaneous injection for three weekly doses
Biological: REMD-477
REMD-477 will be administered as a subcutaneous injection for three weekly doses
Also known as: Volagidemab
Adverse Events
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase inhibitor
Time frame: 22 days
Serious Adverse Events
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Time frame: 22 days
Liver Function Tests (LFT) units per liter (u/L)
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Time frame: 22 days
Blood Glucose measurements
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Time frame: 22 days
Pulse beats per minute
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Time frame: 22 days
breathing Rate breaths per minute
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Time frame: 22 days
Fasting Glucose levels
Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia
Time frame: 22 days
Insulin levels
Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia
Time frame: 22 days
Plan to share: No
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This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Duke University