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NCT04253223 · ClinicalTrials.gov registry record · Phase 1

A Study to Determine Safety and Efficacy of (REMD-477) in Controlling Hyperglycemia Due to Copanlisib

A Phase 1 study, sponsored by Duke University.

Terminated
Registry status
Phase 1
Development phase
1
Enrollment target

NCT04253223 is a Phase 1 study that was terminated before completion, run by Duke University. The registered enrollment target is 1 participants.

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The verdict

NCT04253223, a Phase 1 study, was terminated before completion, sponsored by Duke University.

TERMINATED
Registry status
Phase 1
Development phase
1 participants
Enrollment target

Study Summary

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

Interventions

  • BIOLOGICAL REMD-477

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2020-04-07
Est. Completion 2021-05-05
Phase Phase 1

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT04253223

The ClinicalTrials.gov registry entry for NCT04253223 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which REMD-477 is the first listed.

NCT04253223 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04253223 about?

NCT04253223 is a clinical study titled "A Study to Determine Safety and Efficacy of (REMD-477) in Controlling Hyperglycemia Due to Copanlisib". 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 glycog...

What is the current status of trial NCT04253223?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2020-04-07. Estimated completion is 2021-05-05.

What interventions are being tested in trial NCT04253223?

The interventions under investigation include: REMD-477 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04253223?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.