Diabetic RetinopathyPhase 2NCT06770933
A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01
A Phase 2 study testing VX-01 in people with Diabetic Retinopathy and NPDR - Non Proliferative Diabetic Retinopathy, run by Vantage Biosciences Ltd at 27 sites in 5 countries.
Trial summary
The goal of this clinical trial is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of VX-01 as stand-alone treatment for Diabetic Retinopathy of Non-Proliferative Type (NPDR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, NPDR - Non Proliferative Diabetic Retinopathy
- What is being tested?
- VX-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 27 sitesin 5 countries
- Study dates
- 11 Feb 2025to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Written informed consent must be obtained from the subject prior to any study-related procedures.
- Subject must be aged > 18 years at the time of Screening.
- Subject must have a body mass index (BMI) of between 18 and 40 kg/m2, inclusive.
- Subject has a documented diagnosis of T1DM or T2DM.
- Subject has moderate to severe NPDR, as determined by a Central Reading Centre (CRC) using DRSS in at least one eye
- Subject must have clear ocular media and be able to undergo adequate pupil dilation to allow adequate fundus imaging of both eyes.
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- Female subject must be either:
- Of non-childbearing potential: post-menopausal or documented surgically sterile post hysterectomy (at least 1 month prior to Screening)
- Or, if of childbearing potential, must have a negative serum pregnancy test at Screening and must use 2 acceptable forms of contraception, starting at Screening and throughout the study period and for 28 days after the final IP administration.
- Female subject must not be breastfeeding at Screening or during the study period, and for 28 days after the final IP administration.
- Male subject must be surgically sterile (> 30 days since vasectomy with no viable sperm), or if engaged in sexual relations with a female of childbearing potential, the couple should agree to use 2 acceptable contraceptive methods from Screening, during the study, and for 28 days after last IP administration.
- Female subject must not donate ova or male subject must not donate sperm starting at Screening and throughout the study period, and for 28 days after the final IP administration.
- Subject must have Best Corrected Visual Acuity (BCVA) assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) protocol letters score of ≥ 70 letters in study eye, and ≥ 20 letters in the non-qualified fellow eye.
- Subject must have the ability, in the opinion of the Investigator, and willingness to return for all scheduled visits and perform all assessments.
- Subject agrees not to participate in another interventional study after signing the informed consent and until the End of Study (EOS) visit has been completed.
Who cannot join
- Ophthalmic:
- Presence of CI-DME (with central subfield thickness [CST] measured greater than 325 μm on spectral domain optical coherence tomography [SD-OCT]) threatening the center of the macula (within 1,000 μm of the foveal center) in either eye, or presence of DME requiring treatment.
- Presence of moderate to high-risk PDR (DRSS level 65 or higher).
- Any prior treatment (in either eye) with:
- Focal or grid laser photocoagulation within the past 6 months prior to Screening or pan-retinal photocoagulation (PRP) at any time.
- Systemic or intravitreal anti-vascular endothelial growth factor (VEGF) agents within the last 12 months prior to Screening.
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- Intraocular, sub-tenon or periocular steroids, including triamcinolone and dexamethasone implant within the last 6 months, or suprachoroidal triamcinolone within the last 3 months prior to Screening.
- Fluocinolone implant within the last 3 years prior to Screening.
- Prior treatment for NPDR with any other treatment which is not labelled for NPDR within 1 year prior to Screening (e.g., calcium dobesilate, fibrate medication).
- Vitrectomy at any timepoint prior to Screening.
- Yttrium-Aluminium-Granate (YAG) capsulotomy within 3 months prior to Screening.
- Active uveitis, vitritis, or infection in either eye including infectious conjunctivitis, keratitis, scleritis, or endophthalmitis.
- History of corneal transplant and/or vitrectomy or any other ocular incisional surgery in either eye (e.g., shunt surgery). Note: Subjects who have had cataract or refractive surgery in either that was more than 3 months prior to Screening may be permitted at the discretion of the Investigator.
- Uncontrolled glaucoma, as evidenced by intraocular pressure (IOP) > 25 mmHg despite up to 4 glaucoma medications, or evidence of glaucomatous visual field loss or has advanced glaucoma (e.g., prior shunt surgery) in either eye.
- Clinically significant ocular disease in either eye that in the opinion of the Investigator would preclude participation in the study.
- Presence of macular or retinal vascular disease including DME and/or retinopathy from causes other than diabetes, age-related macular degeneration, pattern dystrophy, choroidal neovascularisation of any cause, retinal vein occlusion, retinal artery occlusion in either eye.
- History of retinal detachment or full-thickness macular hole post intraocular surgery in either eye, or idiopathic or autoimmune uveitis in either eye.
- Any other ocular disease that may cause substantial reduction in BCVA.
- Systemic:
- Known, suspected hypersensitivity or contraindication to IP.
- Uncontrolled diabetes mellitus with HbA1c of ≥ 12%.
- Initiation of treatment with glucagon-like peptide-1 (GLP-1) modulators for glycaemic control and other indications within the last 3 months prior to Screening.
- Initiation of intensive insulin treatment (a pump or multiple daily injections) within 3 months prior to Screening or plans to do so in the next 3 months.
- Current use of coumarin anticoagulants (Coumadin/Warfarin).
- On dialysis or an estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73m2 as per CKD-EPI evaluation at Screening. (Active Diabetic Ketoacidosis or Hyperglycemic Hyperosmolar Nonketotic State).
- Hypertension with resting diastolic blood pressure (BP) > 100 mmHg or systolic BP > 180 mmHg on 2 consecutive measurements at least 5 minutes apart. Note: If the result is out of range, the assessment may be repeated once prior to randomisation for confirmation.
- Resting heart rate outside the specified range (50 to 110 beats per minute). Note: If the result is out of range, the assessment may be repeated once prior to randomisation for confirmation.
- History of chronic liver disease or presence of elevated (defined as > 3 × upper limit of normal) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) consistent with such diagnosis.
- Known to be immunocompromised or receiving immunosuppressive therapy. Note: Subjects receiving low dose corticosteroids may be eligible, at the discretion of the Investigator.
- Currently receiving treatment with a strong inhibitor of the P-glycoprotein transporter (see Section 6.4.2), which may interfere with the IP.
- History of allergy to fluorescein.
- Any disease or medical condition that in the opinion of the Investigator would interfere with the study, prevent the subject from successfully participating in the study, or which might confound the study results.
- Participation in any investigational study within 30 days prior to Screening or planning to participate in any other investigational drug or device clinical trials within 30 days of study completion.
- History of blood transfusion or severe blood loss within 3 months prior to Screening, known hemoglobinopathy, and severe anaemia.
Trial locations and contacts
27 sites in 5 countries.
27 sites in 5 countries
United States9 sites
Southeast Retina Center
Augusta, Georgia, 30909
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Erie Retina Research
Erie, Pennsylvania, 16507
Sterling Vision, PC
Eugene, Oregon, 97401
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740-5940
Florida Retina Institute - Jacksonville Southside
Jacksonville, Florida, 32216
Piedmont Eye Center
Lynchburg, Virginia, 24502
Stanford Byers Eye Institute
Palo Alto, California, 94303
California Retina Consultants- Santa Barbara
Santa Barbara, California, 93103
Australia8 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Eye Clinic Albury Wodonga
Albury, New South Wales, 2640
University of the Sunshine Coast Clinical Trials (Birtinya)
Birtinya, Queensland, 4575
Retina And Eye Consultants Hurstville
Hurstville, New South Wales, 2220
Marsden Eye Specialists
Parramatta, New South Wales, 2150
Sydney Eye Hospital
Sydney, New South Wales, 2000
Sydney Retina Clinic
Sydney, New South Wales, 2000
Sydney West Retina
Westmead, New South Wales, 2145
Malaysia5 sites
Hospital Pulau Pinang
George Town, Pulau Pinang, 10450
University Malaya Medical Centre
Petaling Jaya, Kuala Lumpur Federal Territory of Kuala Lumpur, 59100
Hospital Selayang
Selayang Baru Utara
Hospital Shah Alam
Shah Alam, Selangor, 40000
Hospital Al-sultan Abdullah Uitm
Sungai Buloh, Selangor, 47000
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Hong Kong2 sites
Prince of Wales Hospital The Chinese University of Hong Kong
Shatin
HKU Eye Centre
Wong Chuk Hang
About this study
Official title: A Phase II, Double-Masked, Randomised, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety of Orally Administered VX-01 in Diabetic Retinopathy OF Non-Proliferative Type (NPDR)
The goal of this clinical trial is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of VX-01 as stand-alone treatment for Diabetic Retinopathy of Non-Proliferative Type (NPDR).
The primary objective of the study is to evaluate the efficacy of daily oral doses of VX-01 versus placebo following 52 weeks of treatment.
Read the detailed description
This is a Phase 2, multi-center, double-masked, randomized, placebo-controlled, parallel group study to evaluate the efficacy of oral doses of VX-01 in subjects with moderate to severe NPDR, without CI-DME.
Approximately 100 male and female subjects aged ≥ 18 years with a documented diagnosis of Type 1 Diabetic Mellitus or Type 2 Diabetic Mellitus with moderate to severe NPDR (without CI-DME) will be enrolled, if they meet all the eligibility criteria for the study.
Subjects will be randomized 1:1 to 1 of 2 study cohorts:
- Cohort 1 (n = 50): VX-01 (film-coated tablets, 150 mg administered BID)
- Cohort 2 (n = 50): Placebo (film-coated tablets, administered BID)
Subjects will be stratified by the presence or absence of proliferative diabetic retinopathy (PDR) and by glycated hemoglobin (HbA1c) of ≥ 8.5% or < 8.5% at Screening. All subjects will take 1 tablet of VX-01 or placebo BID for 52 consecutive weeks. All subjects will be followed for 12 weeks after completion of treatment at Week 52.
The Sponsor, study site staff, monitors, personnel, and subjects will be masked to treatment assignment during the entirety of the study.
- Being tested
- VX-01, Placebo
- Keywords
- NPDR, Diabetic Retinopathy, AOC3, VAP-1, SSAO, VAP1, Amine Oxidase Copper containing 3, Amine Oxidase, HPAO
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX-01Drug
There is no physical difference in VX-01 and the placebo. The only difference lies in active ingredient found in VX-01, which is the compound that will be evaluated in the course of this study.
PlaceboDrug
Placebo will be supplied as a tablet identical to test drug but without VX-01. Placebo packaging will be identical to IP in order to keep study personnel and subjects masked.
| Study group | Role | What they receive |
|---|---|---|
| VX-01 | Experimental | Cohort 1 will include 50 subjects who will be randomized to take investigational drug VX-01 (film-coated tablets) at dose of 150 mg, administered BID. Receives: Drug: VX-01 |
| Placebo | Placebo comparator | Cohort 2 will include 50 subjects who will be randomized to receive the placebo drug (film-coated tablets), that will be administered BID. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of oral doses of VX-01 in subjects compared to placebo following 1 year of treatment.
The endpoint of this objective is the proportion of subjects who do not develop a worsening from Baseline in binocular ETDRS DRSS at Week 52. The diabetic retinopathy severity scale (DRSS) is a scale healthcare professionals use to measure the severity and progression of a person's diabetic retinopathy. The main DRSS is the Early Treatment Diabetic Retinopathy Study (ETDRS) scale which will be used in this study.
Measured: From enrollment to the end of treatment at week 52
Secondary outcomes (4)
To evaluate the efficacy of VX-01 in subjects with moderate to severe NPDR without CI-DME by determining the overall change from Baseline in BCVA letter scores.
Endpoint measurement of this objective will be improvement in Best Corrected Visual Acuity (BCVA), i.e. higher scoring at end of treatment compared to enrollment (baseline).
Measured: From enrollment to the end of treatment at week 52
To evaluate the efficacy of VX-01 in subjects with moderate to severe NPDR without CI-DME by determining the overall change from Baseline in the ETDRS DRSS scores.
Endpoint measurement of this objective will be improvement in the Early Treatment Diabetic Retinopathy score (ETDRS), i.e. higher score at end of treatment compared to enrollment (baseline measure)
Measured: From enrollment to the end of treatment at week 52
Incidence of Treatment-Emergent Adverse Events (TEAEs) when taking multiple oral doses of VX-01.
Endpoint measurement of this objective will include assessing the nature, frequency, and severity of systemic and ocular TEAEs across the duration of the study. A lower number of TEAEs would point towards a better safety and tolerability profile of VX-01
Measured: From enrollment to the end of treatment at week 52
Number of subjects developing moderate to high risk proliferative diabetic retinopathy
Measurement of proportion of subjects who develop moderate to high-risk proliferative diabetic retinopathy in either eye at Week 24 and also at Week 52 will be quantified. This will aid in understanding the safety of VX-01.
Measured: From enrollment to the end of treatment at week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start11 Feb 2025
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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
- Model description
- This is a multi-center, double-masked, randomized, placebo-controlled, parallel group study, where subjects will be randomized 1:1 to 1 of 2 study cohort of VX-01 and placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vantage Biosciences Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vantage Biosciences Australia Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770933
- Sponsor's protocol ID
- VX01-DR-201
- Status last verified
- Sep 2026
- First submitted
- 16 Dec 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Masked, Randomised, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety of Orally Administered VX-01 in Diabetic Retinopathy OF Non-Proliferative Type (NPDR)
- ClinicalTrials.gov ID
- NCT06770933
- Acronym / sponsor ID
- VX01-DR-201
- Keywords
- NPDR, Diabetic Retinopathy, AOC3, VAP-1, SSAO, VAP1, Amine Oxidase Copper containing 3, Amine Oxidase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vantage Biosciences LtdIndustry (pharma, biotech, devices)
- Collaborators
- Vantage Biosciences Australia Pty Ltd
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 13 Jan 2025 (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.
The goal of this clinical trial is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of VX-01 as stand-alone treatment for Diabetic Retinopathy of Non-Proliferative Type (NPDR).
The primary objective of the study is to evaluate the efficacy of daily oral doses of VX-01 versus placebo following 52 weeks of treatment.
Detailed description
This is a Phase 2, multi-center, double-masked, randomized, placebo-controlled, parallel group study to evaluate the efficacy of oral doses of VX-01 in subjects with moderate to severe NPDR, without CI-DME.
Approximately 100 male and female subjects aged ≥ 18 years with a documented diagnosis of Type 1 Diabetic Mellitus or Type 2 Diabetic Mellitus with moderate to severe NPDR (without CI-DME) will be enrolled, if they meet all the eligibility criteria for the study.
Subjects will be randomized 1:1 to 1 of 2 study cohorts:
- Cohort 1 (n = 50): VX-01 (film-coated tablets, 150 mg administered BID)
- Cohort 2 (n = 50): Placebo (film-coated tablets, administered BID)
Subjects will be stratified by the presence or absence of proliferative diabetic retinopathy (PDR) and by glycated hemoglobin (HbA1c) of ≥ 8.5% or < 8.5% at Screening. All subjects will take 1 tablet of VX-01 or placebo BID for 52 consecutive weeks. All subjects will be followed for 12 weeks after completion of treatment at Week 52.
The Sponsor, study site staff, monitors, personnel, and subjects will be masked to treatment assignment during the entirety of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multi-center, double-masked, randomized, placebo-controlled, parallel group study, where subjects will be randomized 1:1 to 1 of 2 study cohort of VX-01 and placebo.
| Arm | Type | Receives |
|---|---|---|
| VX-01 | Experimental | Drug: VX-01Cohort 1 will include 50 subjects who will be randomized to take investigational drug VX-01 (film-coated tablets) at dose of 150 mg, administered BID. |
| Placebo | Placebo comparator | Drug: PlaceboCohort 2 will include 50 subjects who will be randomized to receive the placebo drug (film-coated tablets), that will be administered BID. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent must be obtained from the subject prior to any study-related procedures.
- Subject must be aged > 18 years at the time of Screening.
- Subject must have a body mass index (BMI) of between 18 and 40 kg/m2, inclusive.
- Subject has a documented diagnosis of T1DM or T2DM.
- Subject has moderate to severe NPDR, as determined by a Central Reading Centre (CRC) using DRSS in at least one eye
Key exclusion criteria (34 listed)
- Presence of CI-DME (with central subfield thickness [CST] measured greater than 325 μm on spectral domain optical coherence tomography [SD-OCT]) threatening the center of the macula (within 1,000 μm of the foveal center) in either eye, or presence of DME requiring treatment.
- Presence of moderate to high-risk PDR (DRSS level 65 or higher).
- Any prior treatment (in either eye) with:
- Active uveitis, vitritis, or infection in either eye including infectious conjunctivitis, keratitis, scleritis, or endophthalmitis.
- History of corneal transplant and/or vitrectomy or any other ocular incisional surgery in either eye (e.g., shunt surgery). Note: Subjects who have had cataract or refractive surgery in either that was more than 3 months prior to Screening may be permitted at the discretion of the Investigator.
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 |
|---|---|---|
| VX-01There is no physical difference in VX-01 and the placebo. The only difference lies in active ingredient found in VX-01, which is the compound that will be evaluated in the course of this study. | Drug | VX-01 |
| PlaceboPlacebo will be supplied as a tablet identical to test drug but without VX-01. Placebo packaging will be identical to IP in order to keep study personnel and subjects masked. | Drug | Placebo |
Primary outcome
Evaluate the efficacy of oral doses of VX-01 in subjects compared to placebo following 1 year of treatment.
Time frame: From enrollment to the end of treatment at week 52
The endpoint of this objective is the proportion of subjects who do not develop a worsening from Baseline in binocular ETDRS DRSS at Week 52. The diabetic retinopathy severity scale (DRSS) is a scale healthcare professionals use to measure the severity and progression of a person's diabetic retinopathy. The main DRSS is the Early Treatment Diabetic Retinopathy Study (ETDRS) scale which will be used in this study.
4 secondary outcomes
To evaluate the efficacy of VX-01 in subjects with moderate to severe NPDR without CI-DME by determining the overall change from Baseline in BCVA letter scores.
Time frame: From enrollment to the end of treatment at week 52
To evaluate the efficacy of VX-01 in subjects with moderate to severe NPDR without CI-DME by determining the overall change from Baseline in the ETDRS DRSS scores.
Time frame: From enrollment to the end of treatment at week 52
Incidence of Treatment-Emergent Adverse Events (TEAEs) when taking multiple oral doses of VX-01.
Time frame: From enrollment to the end of treatment at week 52
Number of subjects developing moderate to high risk proliferative diabetic retinopathy
Time frame: From enrollment to the end of treatment at week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VX-01 in people with Diabetic Retinopathy and NPDR - Non Proliferative Diabetic Retinopathy, run by Vantage Biosciences Ltd at 27 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 34 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Australia, Malaysia, South Korea, Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
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?
Evaluate the efficacy of oral doses of VX-01 in subjects compared to placebo following 1 year of treatment. (time frame: From enrollment to the end of treatment at week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.