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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: Clinical Trial Phase 1 study, sponsored by Duke University.
NCT04253223 is a Phase 1 study that was terminated before completion, run by Duke University. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase inhibitor
Interventions
- BIOLOGICAL REMD-477
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2020-04-07 |
| Est. Completion | 2021-05-05 |
| Phase | Phase 1 |
Why NCT04253223 stopped before completion
NCT04253223 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which REMD-477 is the first listed.
NCT04253223 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04253223's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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