DNL921 / Healthy Participants / Alzheimer's Disease · Phase 1 Trial

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's Disease

ClinicalTrials.gov · August 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1/1b clinical trial registry record for DNL921, a candidate Alzheimer's disease therapeutic. The study is not yet recruiting and no results have been posted; the record documents planned design, endpoints, and enrollment only.

What was studied

Phase 1, Interventional, Randomized, Sequential, Double masking, Treatment purpose. Alzheimer's Disease, Healthy Participants; age from 18 Years; to 75 Years; accepts healthy volunteers. Intervention: Group 1. Compared with: Group 2 — Placebo Comparator. n = 178.

Key findings

Safety

No efficacy data, clinical outcomes, or adverse event findings are reported. Phase 1 design is not powered to detect clinical benefit; primary aim is safety, tolerability, PK, and PD for dose selection.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an early-phase, first-in-human Phase 1/1b trial registration with no results posted; it is designed to establish safety, tolerability, and dose-range, not to evaluate efficacy.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Part A: Incidence and severity of treatment-emergent averse events (TEAEs) (assessed at 46 days); Parts B and C: Incidence and severity of TEAEs in participants with AD (assessed at 242 days)

DesignPhase 1, Interventional, Randomized, Sequential, Double masking, Treatment purpose

PopulationAlzheimer's Disease, Healthy Participants; age from 18 Years; to 75 Years; accepts healthy volunteers

Sample size178

InterventionGroup 1

ComparatorGroup 2 — Placebo Comparator

Reported figures

Quoted from the source exactly as published.

Estimated enrollment178

PhasePhase 1/1b

Primary outcome measure (Part A)Incidence and severity of treatment-emergent adverse events (TEAEs) at 46 days

Primary outcome measure (Parts B and C)Incidence and severity of TEAEs in participants with AD at 242 days

Study typeInterventional, randomized, placebo-controlled, double-blind, multicenter

Caveats

This is a registry record; no trial results have been posted or published.
Recruitment status is NOT_YET_RECRUITING; enrollment has not begun.
No efficacy data, clinical outcomes, or adverse event findings are reported.
Phase 1 design is not powered to detect clinical benefit; primary aim is safety, tolerability, PK, and PD for dose selection.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Multicenter, randomized, placebo-controlled, double-blind Phase 1/1b design.

Directness

limited

Safety and PK/PD in healthy participants and AD population; not powered for clinical efficacy.

Consistency

insufficient

No results reported in this registry record; consistency cannot be assessed.

Risk of bias

moderate

Blinding and randomization planned; recruitment not yet started; risk mitigation adequate for Phase 1.

Sample adequacy

limited

178 estimated participants across parts A, B, and C; typical Phase 1 size but small for AD cohort.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07758595). This is a study registration, not published results. Lead sponsor: Denali Therapeutics Inc.. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 178 participants (ESTIMATED). Conditions: Alzheimer's Disease, Healthy Participants. Interventions: DRUG: DNL921; DRUG: Placebo. Primary outcome measures: Part A: Incidence and severity of treatment-emergent averse events (TEAEs) , 46 days; Parts B and C: Incidence and severity of TEAEs in participants with AD , 242 days. Brief summary: This is a Phase 1/1b, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of DNL921 in healthy participants and participants with Alzheimer's disease (AD). The principal aim of this study is to obtain safety and tolerability data. This information, together with PK and PD data, will inform dose selection and design of future studies.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

DNL921Healthy ParticipantsDenali TherapeuticsAlzheimer's DiseaseNCT07758595