Open Angle GlaucomaPhase 2NCT06441643

Next Generation Rocklatan

A Phase 2 study testing AR-17043 Ophthalmic Solution, PG043 Ophthalmic Solution and Latanoprost 0.005% Ophthalmic Solution in people with Open Angle Glaucoma and Ocular Hypertension, run by Alcon Research at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this two-stage clinical trial is to assess the safety and hypotensive efficacy of AR-17043 and PG043 ophthalmic solutions in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Open Angle Glaucoma, Ocular Hypertension
What is being tested?: AR-17043 Ophthalmic Solution, PG043 Ophthalmic Solution and Latanoprost 0.005% Ophthalmic Solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 426 participants
Where: 12 sitesUnited States
Study dates: 4 Sep 2024to 14 Nov 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Stage 1 Key Inclusion Criteria;

Diagnosis of OAG or OHT in both eyes.
High unmedicated IOP measurements in the study eye as specified in the protocol.
Corrected visual acuity equal to or better than +1.0 logMAR (Snellen equivalent equal to or better than 20/200) in the study eye.
Other protocol-specified inclusion criteria may apply.

Stage 2 Key Inclusion Criteria:

Diagnosis of OAG or OHT in both eyes.
High unmedicated IOP measurements in the study eye as specified in the protocol.
Corrected visual acuity equal to or better than +0.7 logMAR (Snellen equivalent equal to or better than 20/100) in the study eye.
Other protocol-specified inclusion criteria may apply.

Stage 1 and Stage 2 Key Exclusion Criteria:

Current use of more than 2 ocular hypotensive medications within 30 days (either eye).
Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening.
Glaucoma other than OAG.
Previous glaucoma surgery.
Any abnormality preventing reliable measurements.
Unable to demonstrate proper eyedrop instillation.
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, 80528
Orange County Ophthalmology Medical Group
Garden Grove, California, 92843
United Medical Research Institute
Inglewood, California, 90301
Piedmont Eye Center
Lynchburg, Virginia, 24502
University Eye Specialists
Maryville, Tennessee, 37803
Total Eye Care PA
Memphis, Tennessee, 38119
Eye Research Foundation
Newport Beach, California, 92663
North Bay Eye Associates
Petaluma, California, 94954
Rochester Ophthalmological Group
Rochester, New York, 14618
Coastal Research Associates
Roswell, Georgia, 30076
James D. Branch Ophthalmology
Winston-Salem, North Carolina, 27101

Other trials in United States

About this study

Official title: A Phase II, Prospective, Two-Stage, Double-Masked, Randomized, Multi-Center, Controlled, Dose-Response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-17043 and PG043 (AR-17043/Latanoprost) Ophthalmic Solutions in Subjects With Elevated Intraocular Pressure

Read the detailed description

During Stage 1, approximately 100 adult subjects with OAG or OHT will be randomized to 5 arms: 3 different concentrations of AR-17043, placebo comparator, or netarsudil 0.02% (Rhopressa®) for a treatment duration of 7 days.

During Stage 2, approximately 350 adult subjects with OAG or OHT will be randomized to 5 arms: low and high concentrations of PG043 (AR-17043/latanoprost 0.005%), AR-17043 high concentration, latanoprost, or netarsudil 0.02%/latanoprost 0.005% (Rocklatan®) for a treatment duration of 28 days.

Conditions: Open Angle Glaucoma, Ocular Hypertension
Being tested: AR-17043 Ophthalmic Solution, PG043 Ophthalmic Solution, Latanoprost 0.005% Ophthalmic Solution, Netarsudil 0.02% Ophthalmic Solution, Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution
Keywords: Glaucoma, IOP
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AR-17043 Ophthalmic SolutionDrug
Investigational monotherapy supplied in three concentration levels: low, medium, high
PG043 Ophthalmic SolutionDrug
Investigational fixed dose combination supplied in two concentration levels: low and high
Latanoprost 0.005% Ophthalmic SolutionDrug
Also called Latanoprost
Marketed monotherapy
Netarsudil 0.02% Ophthalmic SolutionDrug
Also called Rhopressa®
Marketed monotherapy
Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic SolutionDrug
Also called Rocklatan®
Marketed fixed dose combination
AR-17043 VehicleDrug
Placebo comparator

Study groups in NCT06441643
Study group	Role	What they receive
AR-17043 low concentration (Stage 1)	Experimental	AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7. Receives: Drug: AR-17043 Ophthalmic Solution
AR-17043 medium concentration (Stage 1)	Experimental	AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7. Receives: Drug: AR-17043 Ophthalmic Solution
AR-17043 high concentration (Stage 1)	Experimental	AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7. Receives: Drug: AR-17043 Ophthalmic Solution
AR-17043 vehicle (Stage 1)	Placebo comparator	AR-17043 Vehicle, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7. Receives: Drug: AR-17043 Vehicle
Rhopressa (Stage 1)	Active comparator	Netarsudil 0.02% Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7. Receives: Drug: Netarsudil 0.02% Ophthalmic Solution
PG043 low concentration (Stage 2)	Experimental	PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. Receives: Drug: PG043 Ophthalmic Solution
PG043 high concentration (Stage 2)	Experimental	PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. Receives: Drug: PG043 Ophthalmic Solution
AR-17043 high concentration (Stage 2)	Active comparator	AR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. Receives: Drug: AR-17043 Ophthalmic Solution
Latanoprost (Stage 2)	Active comparator	Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. Receives: Drug: Latanoprost 0.005% Ophthalmic Solution
Rocklatan (Stage 2)	Active comparator	Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. Receives: Drug: Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean diurnal IOP at Day 8 (Stage 1)
Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the four measurements.
Measured: Day 8 (8:00, 10:00, 12:00, 16:00)
Mean diurnal IOP at Day 29 (Stage 2)
Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the three measurements.
Measured: Day 29 (8:00, 10:00, 16:00)

Secondary outcomes (10)

Mean IOP at each post-treatment timepoint (Stage 1)
Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint.
Measured: Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)
Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.
Measured: Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)
Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.
Measured: Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)
Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.
Measured: Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)
Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.
Measured: Baseline (8:00, 10:00, 12:00, 16:00); Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean IOP at each post-treatment timepoint (Stage 2)
Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint.
Measured: Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)
Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.
Measured: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)
Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.
Measured: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)
Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.
Measured: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)
Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.
Measured: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Sep 202414 Nov 2025

First posted4 Jun 2024
Study start4 Sep 2024
Primary completion14 Nov 2025
Study completion14 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 426 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06441643
Sponsor's protocol ID: GLR305-E001
Status last verified: Nov 2025
First submitted: 29 May 2024
Last updated: 18 Nov 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Prospective, Two-Stage, Double-Masked, Randomized, Multi-Center, Controlled, Dose-Response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-17043 and PG043 (AR-17043/Latanoprost) Ophthalmic Solutions in Subjects With Elevated Intraocular Pressure
ClinicalTrials.gov ID: NCT06441643
Acronym / sponsor ID: GLR305-E001
Conditions: Open Angle Glaucoma, Ocular Hypertension
Keywords: Glaucoma, IOP
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 426 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 4 Sep 2024 (actual)
Primary completion: 14 Nov 2025 (actual)
Study completion: 14 Nov 2025 (actual)
First posted: 4 Jun 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
AR-17043 low concentration (Stage 1)	Experimental	Drug: AR-17043 Ophthalmic SolutionAR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
AR-17043 medium concentration (Stage 1)	Experimental	Drug: AR-17043 Ophthalmic SolutionAR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
AR-17043 high concentration (Stage 1)	Experimental	Drug: AR-17043 Ophthalmic SolutionAR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
AR-17043 vehicle (Stage 1)	Placebo comparator	Drug: AR-17043 VehicleAR-17043 Vehicle, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Rhopressa (Stage 1)	Active comparator	Drug: Netarsudil 0.02% Ophthalmic SolutionNetarsudil 0.02% Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
PG043 low concentration (Stage 2)	Experimental	Drug: PG043 Ophthalmic SolutionPG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
PG043 high concentration (Stage 2)	Experimental	Drug: PG043 Ophthalmic SolutionPG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
AR-17043 high concentration (Stage 2)	Active comparator	Drug: AR-17043 Ophthalmic SolutionAR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Latanoprost (Stage 2)	Active comparator	Drug: Latanoprost 0.005% Ophthalmic SolutionLatanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Rocklatan (Stage 2)	Active comparator	Drug: Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic SolutionNetarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AR-17043 Ophthalmic SolutionInvestigational monotherapy supplied in three concentration levels: low, medium, high	Drug	AR-17043 high concentration (Stage 1), AR-17043 high concentration (Stage 2), AR-17043 low concentration (Stage 1), AR-17043 medium concentration (Stage 1)
PG043 Ophthalmic SolutionInvestigational fixed dose combination supplied in two concentration levels: low and high	Drug	PG043 high concentration (Stage 2), PG043 low concentration (Stage 2)
Latanoprost 0.005% Ophthalmic SolutionAlso: LatanoprostMarketed monotherapy	Drug	Latanoprost (Stage 2)
Netarsudil 0.02% Ophthalmic SolutionAlso: Rhopressa®Marketed monotherapy	Drug	Rhopressa (Stage 1)
Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic SolutionAlso: Rocklatan®Marketed fixed dose combination	Drug	Rocklatan (Stage 2)
AR-17043 VehiclePlacebo comparator	Drug	AR-17043 vehicle (Stage 1)

Primary outcome

Mean diurnal IOP at Day 8 (Stage 1)
Time frame: Day 8 (8:00, 10:00, 12:00, 16:00)
Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the four measurements.
Mean diurnal IOP at Day 29 (Stage 2)
Time frame: Day 29 (8:00, 10:00, 16:00)
Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the three measurements.

10 secondary outcomes

Mean IOP at each post-treatment timepoint (Stage 1)
Time frame: Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)
Time frame: Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)
Time frame: Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)
Time frame: Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)
Time frame: Baseline (8:00, 10:00, 12:00, 16:00); Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean IOP at each post-treatment timepoint (Stage 2)
Time frame: Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)
Time frame: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)
Time frame: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)
Time frame: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)
Time frame: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trial Lead, Pharma study director

Alcon Research, LLC

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean diurnal IOP at Day 8 (Stage 1) (time frame: Day 8 (8:00, 10:00, 12:00, 16:00)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06441643.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.