Trial results
$RZLT — ersodetug
Rezolute, Inc. (RZLT) ersodetug: trial results in Tumor hyperinsulinism (tumor HI), 2026.
The catalyst
"Enrollment is in progress and topline results are expected before the end of 2026."
— Rezolute, Inc., 8-K filed 2026-09-24 · the filing. Checked word for word against the stored document when this page was built; a sentence that did not check out would not be here.
- Event id
RZLT-ERSODETUG-2026- Company
- Rezolute, Inc.
- Kind
- Trial results
- Indication
- Tumor hyperinsulinism (tumor HI)
- Window
- 2026-12-01 – 2026-12-31
- Status
- bar_published
The bar
Published 2026-10-19 21:27 ET, before the event. The text below is the hashed text: paste it into the verify page and your browser will recompute the same digest.
Pass if: A primary responder must meet the stated reduction-from-baseline threshold in IV GIR · At least the company-stated open-label responder count meets the primary GIR threshold
Great if (any one): At least the prior EAP percentage achieves complete discontinuation of IV dextrose/TPN; this is…
6 items we could not source — full detail below
EVENT RZLT-ERSODETUG-2026 SCORED SET evaluable FLOOR floor_primary_gir_reduction_definition primary_gir_reduction_percent >= 50 | A primary responder must meet the stated reduction-from-baseline threshold in IV GIR. BAR bar_primary_responder_count primary_gir_responder_count >= 9 | At least the company-stated open-label responder count meets the primary GIR threshold. DIFF diff_complete_iv_dextrose_tpn_discontinuation complete_iv_dextrose_tpn_discontinuation_percent >= 75 | At least the prior EAP percentage achieves complete discontinuation of IV dextrose/TPN; this is supportive, not the registered primary endpoint.
- SHA-256
8f930339f9c4670b07ab0b4fa0ebeed8275a86d0a62266e84d3af6605f7096ab- Frozen
- yes
- Public post
- https://x.com/i/web/status/2112354938688860637
- OpenTimestamps
- RZLT-ERSODETUG-2026.txt.ots, submitted 2026-10-21 03:45 ET. A proof that this hash existed by then, anchored in Bitcoin and checkable with the standard
ots verifyclient beside the hashed text, without relying on us or on X. - Wayback Machine
- snapshot of this page, 2026-10-19 21:27 ET
Criteria as committed
Floor — all must pass
| Id | Field | Test | As written |
|---|---|---|---|
floor_primary_gir_reduction_definition |
primary_gir_reduction_percent |
>= 50 |
A primary responder must meet the stated reduction-from-baseline threshold in IV GIR. |
Bar — all must pass
| Id | Field | Test | As written |
|---|---|---|---|
bar_primary_responder_count |
primary_gir_responder_count |
>= 9 |
At least the company-stated open-label responder count meets the primary GIR threshold. |
Differentiators — one upgrades IN_LINE to BEAT
| Id | Field | Test | As written |
|---|---|---|---|
diff_complete_iv_dextrose_tpn_discontinuation |
complete_iv_dextrose_tpn_discontinuation_percent |
>= 75 |
At least the prior EAP percentage achieves complete discontinuation of IV dextrose/TPN; this is supportive, not the registered primary endpoint. |
What we could not source before the event
- No document states the upLIFT primary-result analysis population; scored_set is null.
- No separate formal alpha, confidence-interval, multiplicity, non-inferiority-margin, or power criterion was found.
- No numerical upLIFT safety or tolerability veto threshold was found.
- No manual comparator or options snapshot data were supplied.
- No exact event date was found; company guidance is limited to the second half of 2026.
- analysis population: evaluable — the registry lists a single-group study, which reports the patients it could assess; change it in the editor if the protocol says otherwise
Verdicts
No verdict has been published for this event yet.