Trial · NCT03845582

Phase 2/3 Study of ALK-001 in Geographic Atrophy

NCT03845582, Phase 2, Phase 3, Completed, Alkeus Pharmaceuticals, Inc.; results first posted 2025-10-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 2/3 Study of ALK-001 in Geographic Atrophy. Trials, record NCT03845582. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03845582

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase 2/3 Study of ALK-001 in Geographic Atrophy
NCT number: NCT03845582
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 200 participants, actual
Lead sponsor: Alkeus Pharmaceuticals, Inc.
Conditions: Geographic Atrophy, Age Related Macular Degeneration, AMD, Atrophy, Geographic
Interventions: ALK-001 oral capsule, Placebo oral capsule
First posted: 2019-02-19
Last updated: 2025-11-03
Results first posted: 2025-10-16

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Growth Rate of GA Lesions, as Assessed by Fundus Autofluorescence (FAF)	Baseline to 24 months
Secondary	Number of Participants With Adverse Events	Baseline to 24 months
Secondary	Changes in Visual Acuity	Baseline to 24 months	Changes in LLVA and BCVA

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Growth Rate of GA Lesions, as Assessed by Fundus Autofluorescence (FAF)	Baseline to 24 months	mm2/year	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With Adverse Events	Baseline to 24 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Changes in Visual Acuity	Baseline to 24 months	letters	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Growth Rate of GA Lesions, as Assessed by Fundus Autofluorescence (FAF)	ALK-001		1.62	Standard Error 0.081	mm2/year
Growth Rate of GA Lesions, as Assessed by Fundus Autofluorescence (FAF)	Placebo		1.87	Standard Error 0.116	mm2/year
Number of Participants With Adverse Events	ALK-001		97		Participants
Number of Participants With Adverse Events	Placebo		52		Participants
Changes in Visual Acuity	ALK-001	LLVA	-3.896	Standard Error 1.316	letters
Changes in Visual Acuity	Placebo	LLVA	-8.298	Standard Error 1.835	letters
Changes in Visual Acuity	ALK-001	BCVA	-6.862	Standard Error 1.251	letters
Changes in Visual Acuity	Placebo	BCVA	-10.161	Standard Error 1.771	letters

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	ALK-001	135
Overall Study	STARTED	Placebo	63
Overall Study	COMPLETED	ALK-001	94
Overall Study	COMPLETED	Placebo	43
Overall Study	NOT COMPLETED	ALK-001	41
Overall Study	NOT COMPLETED	Placebo	20

Source ClinicalTrials.gov

Adverse events98

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Blood triglycerides increased	Investigations	ALK-001	15	135
other	Blood triglycerides increased	Investigations	Placebo	5	63
other	Blood alkaline phosphatase increased	Investigations	ALK-001	10	135
other	Blood alkaline phosphatase increased	Investigations	Placebo	5	63
other	Glomerular filtration rate decreased	Investigations	ALK-001	6	135
other	Glomerular filtration rate decreased	Investigations	Placebo	4	63
other	Corona virus infection	Infections and infestations	ALK-001	7	135
other	Corona virus infection	Infections and infestations	Placebo	6	63
other	Urinary tract infection	Infections and infestations	ALK-001	5	135
other	Urinary tract infection	Infections and infestations	Placebo	5	63

1 to 10 of 98Source ClinicalTrials.gov

See all 98 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ALK-001	5	135
Total, all-cause mortality	Placebo	1	63
Total, other adverse events	ALK-001	59	135
Total, other adverse events	Placebo	34	63
Total, serious adverse events	ALK-001	26	135
Total, serious adverse events	Placebo	14	63

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21075840	BACKGROUND	PubMed
23914132	BACKGROUND	PubMed
26427432	BACKGROUND	PubMed
37702300	DERIVED	PubMed
42242606	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
ALK-001 vs Placebo: Number of Participants With Adverse Events	Trial comparisons
ALK-001 vs Placebo: deaths from any cause	Trial comparisons
ALK-001 vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03845582

GET https://conductscience.org/api/trials/v1/NCT03845582/events?page=2

API reference For AI assistants