Overactive BladderPhase 3NCT04103450
Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia
A Phase 3 study testing Vibegron in people with Overactive Bladder, run by Urovant Sciences GmbH at 35 sites in 2 countries.
Trial summary
This study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (OAB) symptoms on pharmacological therapy for Benign Prostatic Hyperplasia (BPH) who previously completed treatment in Study URO-901-3005 (NCT03902080). Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Vibegron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 35 sitesin 2 countries
- Study dates
- 19 Sep 2019to 29 Jul 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has completed participation of the 24-week double-blind treatment period in Study URO-901-3005 (NCT03902080) and demonstrated compliance with the study procedures and study medication schedule in the opinion of the investigator.
- Participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Participant has the ability to continue to receive a stable dose of Benign Prostatic Hyperplasia (BPH) treatment with either a) alpha blocker monotherapy or b) alpha blocker +5-ARI.
- In the opinion of the investigator, the participant is able and willing to comply with the requirements of the protocol, including completing study questionnaires and the Bladder Diary.
Who cannot join
- Participant experienced any Serious Adverse Event in Study URO-901-3005 that was reported as "possibly or probably related" to study treatment by the investigator.
- Participant is using any prohibited medications
- Participant has uncontrolled hyperglycemia (defined as fasting blood glucose >150 milligrams per deciliter [mg/dL] or 8.33 millimoles per Liter [mmol/L] and/or non-fasting blood glucose >200 mg/dL or 11.1 mmol/L) based on most recent available lab results in Study URO-901-3005 or uncontrolled in the opinion of the investigator.
- Participant has uncontrolled hypertension (systolic blood pressure of ≥180 millimeters of mercury [mmHg] and/or diastolic blood pressure of ≥100 mmHg) or has a resting heart rate (by pulse) >100 beats per minute.
- Participant has systolic blood pressures ≥160 mmHg but <180 mmHg, unless deemed by the investigator as safe to proceed in this study and able to complete the study per protocol.
- Participant has current evidence of any clinically significant condition, therapy, lab abnormality, or other circumstances that might, in the opinion of the investigator, confound the results of the study, interfere with the participant's ability to comply with study procedures, or make participation in the study not in the participant's best interest.
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States31 sites
Boston Clinical Trials Inc - Urology
Boston, Massachusetts, 02131
Imagine Research of Palm Beach County - Urology
Boynton Beach, Florida, 33435
Seattle Urology Research Center
Burien, Washington, 98166
Tampa Bay Medical Research
Clearwater, Florida, 33761
Premier Urology Group, LLC
Edison, New Jersey, 08837
New Jersey Urology NJU
Englewood, New Jersey, 07631
AccuMed Research Associates
Garden City, New York, 11530
Urological Surgeons of Long Island
Garden City, New York, 11530
Advances In Health, Inc.
Houston, Texas, 77030
Private Practice
Huntsville, Alabama, 35801
Excel Clinical Research - Internal Medicine
Las Vegas, Nevada, 89109
Private Practice
Las Vegas, Nevada, 89144
Clinical Trials Research
Lincoln, California, 95648
American Institute of Research
Los Angeles, California, 90017
Quantum Clinical Trials
Miami, Florida, 33140
Clinical Research Solutions
Middleburg Heights, Ohio, 44130
Tri Valley Urology Medical Group
Murrieta, California, 92562
DelRicht Research
New Orleans, Louisiana, 70115
Adult & Pediatric Urology P.C. - Urology
Omaha, Nebraska, 68114
Urology Center Of Florida
Pompano Beach, Florida, 33060
Poplar Bluff Urology
Poplar Bluff, Missouri, 63901
Beaumont Hospital Royal Oak - Urology Research
Royal Oak, Michigan, 48703
Northern California Research Corp
Sacramento, California, 95821
Wasatch Clinical Research LLC
Salt Lake City, Utah, 84107
San Diego Clinical Trials
San Diego, California, 91942
CentraCare Clinic - Adult & Pediatric Urology
Sartell, Minnesota, 56377
Regional Urology, LLC
Shreveport, Louisiana, 71106
Precision Clinical Research
Sunrise, Florida, 33351
Skyline Urology
Torrance, California, 90505
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, 02472
Clinical Research of Central Florida
Winter Haven, Florida, 33880
Poland4 sites
Centrum Medyczne Linden
Krakow
Centrum Medyczne PROMED
Krakow
Medicome Sp. z o.o.
Oświęcim
Nzoz Heureka
Piaseczno
About this study
Official title: A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
This study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (OAB) symptoms on pharmacological therapy for Benign Prostatic Hyperplasia (BPH) who previously completed treatment in Study URO-901-3005 (NCT03902080).
- Conditions
- Overactive Bladder
- Being tested
- Vibegron
- Keywords
- Overactive Bladder, Benign Prostatic Hyperplasia, Vibegron, Beta-3 adrenergic receptor (β3-AR), β3-AR agonist
- Medical subject headings
- Urinary Bladder, Overactive, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibegronDrug
Also called RVT-901, MK-4618, KRP-114V, URO-901
oral administration
| Study group | Role | What they receive |
|---|---|---|
| Vibegron | Experimental | Participants will receive 75 milligrams (mg) vibegron orally once daily (QD). Receives: Drug: Vibegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%)
Adverse events were collected in participants from time each participant provided informed consent in parent study through Follow-up Visit (approximately 5 days after the last dose of study drug) in this extension study (URO-901-3006 [NCT03902080]). For the 28-Week Vibegron group, AEs recorded prior to initiation of vibegron (ie, while receiving placebo in the parent study) were reported as AEs in the parent study. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAE of >5% has been reported.
Measured: Up to Week 52
Number of Participants With Clinically Significant Changes in Hematology Parameters
Blood samples were collected for the analysis of hematology parameters - Hematocrit, hemoglobin, platelet count, white blood cells (WBC [total and differential]), and red blood cells (RBC).
Measured: Up to Week 52
Number of Participants With Clinically Significant Changes in Chemistry Parameters
Blood samples were collected for the analysis of chemistry parameters - Albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, calcium, chloride, creatininea, glucose (fasting or nonfasting), potassium, sodium, total bilirubin, direct bilirubin, blood urea nitrogen (BUN), and total cholesterol.
Measured: Up to Week 52
Number of Participants With Clinically Significant Changes in Urinary Parameters
Urine samples were collected for the analysis of urinary parameters- Blood, glucose, protein, specific gravity, microscopic exam (RBCs, WBCs, epithelial cells, and bacteria), potential of hydrogen (pH) and color
Measured: Up to Week 52
Number of Participants With Clinically Significant Changes in Coagulation Parameter
Blood samples were collected for the analysis of coagulation parameters- international normalized ratio (INR), prothrombin time (PT) and activated partial thromboplastin time (APTT).
Measured: Up to Week 52
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Blood pressure measurements were taken with the participant in the sitting position. Baseline is defined as the last recorded value on or prior to the date of randomization in the parent study URO-901-3005. Change from Baseline was calculated as maximum post-Baseline value minus Baseline value.
Measured: Baseline; Week 52
Change From Baseline in Heart Rate
Heart Rate was measured with the participant in the sitting position. Baseline is defined as the last recorded value on or prior to the date of randomization in the parent study URO-901-3005. CFB was calculated as maximum post-Baseline value minus Baseline value.
Measured: Baseline; Week 52
Secondary outcomes (6)
Change From Baseline at Week 52 in the Average Number of Micturition Episodes Per Day
Micturition is defined as "Urinated in Toilet" as indicated on Bladder Diary. Micturition episodes are the number of times participants voided in the toilet as indicated on the Bladder Diary, either by marking the 'urinated in toilet' question as yes or recording non-zero volume voided. Average number of micturition episodes/day was calculated using records within the diary analysis visit divided by non-missing diary days (diary days with at least one void reported). A "Diary Day" is defined as the time between when the participants gets up for the day (ie, the time the participant got up for the day yesterday to the time participant got up for the day today; approximately a 24-hour period). The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline; Week 52
Change From Baseline at Week 52 in the Average Number of Urgency Episodes Per Day
The number of urgency episodes was defined as the number of times a participant checked that they had the need to urinate immediately as indicated on the Bladder Diary. Average number of daily urgency episodes at each study visit was calculated as the total number of urgency episodes using records within the diary analysis visit windows divided by non-missing diary days. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline; Week 52
Change From Baseline at Week 52 in the Average Number of Nocturia Episodes Per Night
A nocturia episode is defined as waking to pass urine during the main sleep period as indicated on the Bladder diary. Average number of nocturia episode at each study visit was calculated as the total number of nocturia episode recorded within the diary analysis visit windows divided by non-missing diary days. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline; Week 52
Change From Baseline at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day in Participants With Incontinence
The number of UUI episodes was defined as the number of times a participant checked that they had "urge" as the main reason for leakage. Average UUI episodes per day at each study visit was calculated as total number of UUI episodes within the diary analysis visit windows divided by non-missing diary days. The UUI was analyzed for participants with UI at Baseline. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Week 52
Change From Baseline at Week 52 in the Average of the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall)
The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS is based on 7 questions concerning urinary symptoms and 1 question concerning quality of life. Each question concerning urinary symptoms allows the participant to choose 1 out of 6 answers indicating increasing severity of the symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Higher scores represent greater severity of symptoms. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Week 52
Change From Baseline at Week 52 in the Average Volume Voided Per Micturition
Total volume voided was calculated using all urinary volumes collected regardless of whether participant checked "Urinated in Toilet" or not. Average volume voided per micturition at each study visit was calculated as the total volume voided recorded divided by the number of micturitions with volume recorded. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start19 Sep 2019
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive BladderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Long-term extension
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urovant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Urovant Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103450
- Sponsor's protocol ID
- URO-901-3006
- Other IDs
- 2018-003136-72, 2018
- Status last verified
- Jun 2024
- First submitted
- 23 Sep 2019
- Last updated
- 21 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Urovant is committed to sharing patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Data requests will be reviewed and approved on the basis of scientific merit. All data provided will be anonymized according to applicable laws and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT04103450
- Acronym / sponsor ID
- URO-901-3006
- Conditions
- Overactive Bladder
- Keywords
- Overactive Bladder, Benign Prostatic Hyperplasia, Vibegron, Beta-3 adrenergic receptor (β3-AR), β3-AR agonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Urovant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Posted 21 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (OAB) symptoms on pharmacological therapy for Benign Prostatic Hyperplasia (BPH) who previously completed treatment in Study URO-901-3005 (NCT03902080).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Long-term extension
| Arm | Type | Receives |
|---|---|---|
| Vibegron | Experimental | Drug: VibegronParticipants will receive 75 milligrams (mg) vibegron orally once daily (QD). |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant has completed participation of the 24-week double-blind treatment period in Study URO-901-3005 (NCT03902080) and demonstrated compliance with the study procedures and study medication schedule in the opinion of the investigator.
- Participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Participant has the ability to continue to receive a stable dose of Benign Prostatic Hyperplasia (BPH) treatment with either a) alpha blocker monotherapy or b) alpha blocker +5-ARI.
- In the opinion of the investigator, the participant is able and willing to comply with the requirements of the protocol, including completing study questionnaires and the Bladder Diary.
Key exclusion criteria (6 listed)
- Participant experienced any Serious Adverse Event in Study URO-901-3005 that was reported as "possibly or probably related" to study treatment by the investigator.
- Participant is using any prohibited medications
- Participant has uncontrolled hyperglycemia (defined as fasting blood glucose >150 milligrams per deciliter [mg/dL] or 8.33 millimoles per Liter [mmol/L] and/or non-fasting blood glucose >200 mg/dL or 11.1 mmol/L) based on most recent available lab results in Study URO-901-3005 or uncontrolled in the opinion of the investigator.
- Participant has uncontrolled hypertension (systolic blood pressure of ≥180 millimeters of mercury [mmHg] and/or diastolic blood pressure of ≥100 mmHg) or has a resting heart rate (by pulse) >100 beats per minute.
- Participant has systolic blood pressures ≥160 mmHg but <180 mmHg, unless deemed by the investigator as safe to proceed in this study and able to complete the study per protocol.
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 |
|---|---|---|
| VibegronAlso: RVT-901, MK-4618, KRP-114V, URO-901oral administration | Drug | Vibegron |
Primary outcome
Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%)
Time frame: Up to Week 52
Adverse events were collected in participants from time each participant provided informed consent in parent study through Follow-up Visit (approximately 5 days after the last dose of study drug) in this extension study (URO-901-3006 [NCT03902080]). For the 28-Week Vibegron group, AEs recorded prior to initiation of vibegron (ie, while receiving placebo in the parent study) were reported as AEs in the parent study. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAE of >5% has been reported.
Number of Participants With Clinically Significant Changes in Hematology Parameters
Time frame: Up to Week 52
Blood samples were collected for the analysis of hematology parameters - Hematocrit, hemoglobin, platelet count, white blood cells (WBC [total and differential]), and red blood cells (RBC).
Number of Participants With Clinically Significant Changes in Chemistry Parameters
Time frame: Up to Week 52
Blood samples were collected for the analysis of chemistry parameters - Albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, calcium, chloride, creatininea, glucose (fasting or nonfasting), potassium, sodium, total bilirubin, direct bilirubin, blood urea nitrogen (BUN), and total cholesterol.
Number of Participants With Clinically Significant Changes in Urinary Parameters
Time frame: Up to Week 52
Urine samples were collected for the analysis of urinary parameters- Blood, glucose, protein, specific gravity, microscopic exam (RBCs, WBCs, epithelial cells, and bacteria), potential of hydrogen (pH) and color
Number of Participants With Clinically Significant Changes in Coagulation Parameter
Time frame: Up to Week 52
Blood samples were collected for the analysis of coagulation parameters- international normalized ratio (INR), prothrombin time (PT) and activated partial thromboplastin time (APTT).
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Time frame: Baseline; Week 52
Blood pressure measurements were taken with the participant in the sitting position. Baseline is defined as the last recorded value on or prior to the date of randomization in the parent study URO-901-3005. Change from Baseline was calculated as maximum post-Baseline value minus Baseline value.
Change From Baseline in Heart Rate
Time frame: Baseline; Week 52
Heart Rate was measured with the participant in the sitting position. Baseline is defined as the last recorded value on or prior to the date of randomization in the parent study URO-901-3005. CFB was calculated as maximum post-Baseline value minus Baseline value.
6 secondary outcomes
Change From Baseline at Week 52 in the Average Number of Micturition Episodes Per Day
Time frame: Baseline; Week 52
Change From Baseline at Week 52 in the Average Number of Urgency Episodes Per Day
Time frame: Baseline; Week 52
Change From Baseline at Week 52 in the Average Number of Nocturia Episodes Per Night
Time frame: Baseline; Week 52
Change From Baseline at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day in Participants With Incontinence
Time frame: Baseline; Week 52
Change From Baseline at Week 52 in the Average of the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall)
Time frame: Baseline; Week 52
Change From Baseline at Week 52 in the Average Volume Voided Per Micturition
Time frame: Baseline; Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Urovant is committed to sharing patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Data requests will be reviewed and approved on the basis of scientific merit. All data provided will be anonymized according to applicable laws and regulations.
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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.
Study Director study director
Urovant Sciences
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vibegron in people with Overactive Bladder, run by Urovant Sciences GmbH at 35 sites in 2 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Poland. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%) (time frame: Up to Week 52). The study lists 7 primary outcomes in all. 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 21 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.