A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)
← catalyst calendarNCT05262023 · readout ≤ 134 d
Sponsored by Denali Therapeutics Inc. (industry) · DNLI — their whole pipeline →. With Takeda.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
85actual
Sites
26
Countries
Belgium, Brazil, Colombia +9
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-02-01 | actual | When the study began enrolling |
| Primary completion | Dec 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Nov 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2022-03-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Frontotemporal Dementia
Interventions
- Drug: DNL593
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFIncidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)
measured up to 18 months
Incidence of treatment-emergent clinically significant abnormalities in safety laboratory values
measured up to 18 months
Change from baseline in vital sign measurements: systolic and diastolic blood pressure
measured up to 18 months
Change from baseline in vital sign measurements: heart rate
measured up to 18 months
Change from baseline in vital sign measurements: respiratory rate
measured up to 18 months
Change from baseline in vital sign measurements: body temperature
measured up to 18 months
Change from baseline in electrocardiogram (ECG) results including PR, QRS, and QTcF intervals
measured up to 18 months
Incidence of treatment-emergent clinically significant abnormalities in physical/neurological examination findings
measured up to 18 months
Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS; Parts B and C only)
measured up to 18 months
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