Short Bowel SyndromePhase 3EASE SBS 4NCT04991311

The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome

A Phase 3 study testing Glepaglutide in people with Short Bowel Syndrome, run by Zealand Pharma at 1 site in Denmark.

Completed

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

Trial summary

The purpose of this trial is to investigate the long-term effect of glepaglutide on the intestinal absorption, nutritional status of participants with Short Bowel Syndrome (SBS). The trial will also investigate whether glepaglutide is safe during long-term use. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Short Bowel Syndrome
What is being tested?: Glepaglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteDenmark
Study dates: 10 Aug 2021to 5 Sep 2023
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 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Age greater than or equal to 18 years and less than or equal to 90 years at screening
Stable condition of SBS either with intestinal failure (SBS-IF) or intestinal insufficiency. For patients with SBS-IF, a stable condition is defined as less than 25 percent change in parenteral support (PS) volume or energy content for 4 weeks prior to screening.
Stable body weight (less than 5 percent change in weight in the 3 months prior to screening)
Wet weight of fecal excretion greater than or equal to 1500 grams per day demonstrated during a hospital stay prior to screening

Who cannot join

More than 2 SBS-related or PS-related hospitalizations (e.g., catheter-related bacteremia/sepsis, bowel obstruction, severe water-electrolytes disturbances, etc.) within 6 months prior to screening
Poorly controlled inflammatory bowel disease (IBD) that is moderately or severely active or fistula interfering with measurements or examinations required in the trial
Current bowel obstruction
Known radiation enteritis or significant villous atrophy, e.g., due to active celiac disease
Cardiac disease defined as: decompensated heart failure (New York Heart Association [NYHA] Class III-IV), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to screening
Any history of colon cancer. History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free state for at least 5 years
Use of glucagon-like peptide-1 (GLP-1), GLP-2, human growth hormone (HGH), somatostatin, or analogs thereof, within 3 months prior to screening

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Rigshospitalet
Copenhagen

Other trials in Denmark

About this study

Official title: A Single-Center Phase 3b Trial Investigating the Long-term Effect on Intestinal Absorption, Nutritional Status and Long-Term Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome (SBS)

Participants will have 14 visits with the study doctor. At 2 of these, participants will spend 48 hours at the trial site, one visit at the start of the trial and one after 24 weeks of treatment with glepaglutide. At all visits, participants will meet with trial staff and will have blood tests along with other clinical checks and tests done. Participants will be asked about their health and medical history.

Conditions: Short Bowel Syndrome
Being tested: Glepaglutide
Medical subject headings: Short Bowel Syndrome

What participants receive

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

GlepaglutideDrug
Also called ZP1848
Glepaglutide will be delivered in a single-use autoinjector.

Study groups in NCT04991311
Study group	Role	What they receive
once-weekly glepaglutide	Experimental	All participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.) Receives: Drug: Glepaglutide

What is being measured

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

Change in Absorption of Wet Weight/Fluids
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
Measured: from Week 0 (baseline) to Week 24

Secondary outcomes (26)

Change in Absorption of Energy
Oral intake minus fecal excretion: measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. Energy absorption was measured by bomb calorimetry.
Measured: from Week 0 (baseline) to Week 24
Change in Absorption of Carbohydrates
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
Measured: from Week 0 (baseline) to Week 24
Change in Absorption of Lipids
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
Measured: from Week 0 (baseline) to Week 24
Change in Absorption of Proteins
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
Measured: from Week 0 (baseline) to Week 24
Change in Absorption of Sodium
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
Measured: from Week 0 (baseline) to Week 24
Change in Absorption of Potassium
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
Measured: from Week 0 (baseline) to Week 24
Change in Absorption of Calcium
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
Measured: from Week 0 (baseline) to Week 24
Change in Absorption of Magnesium
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
Measured: from Week 0 (baseline) to Week 24
Change in Weekly Parenteral Support (PS) Volume
Only for participants with Short Bowel Syndrome with Intestinal Failure (SBS-IF). PS use was recorded in patient diaries throughout the trial, including type and volume used.
Measured: from Week 0 (baseline) to Week 12
Change in Weekly PS Volume
Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
Measured: from Week 0 (baseline) to Week 24
Change in Weekly PS Carbohydrates
Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
Measured: from Week 0 (baseline) to Week 12
Change in Weekly PS Carbohydrates
Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
Measured: from Week 0 (baseline) to Week 24
Change in Weekly PS Lipids
Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
Measured: from Week 0 (baseline) to Week 12
Change in Weekly PS Lipids
Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
Measured: from Week 0 (baseline) to Week 24
Change in Weekly PS Proteins
Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
Measured: from Week 0 (baseline) to Week 12
Change in Weekly PS Proteins
Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
Measured: from Week 0 (baseline) to Week 24
Change in Weekly PS Sodium
Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
Measured: from Week 0 (baseline) to Week 12
Change in Weekly PS Sodium
Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
Measured: from Week 0 (baseline) to Week 24
Change in Weekly PS Potassium
Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
Measured: from Week 0 (baseline) to Week 12
Change in Weekly PS Potassium
Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
Measured: from Week 0 (baseline) to Week 24
Change in Weekly PS Magnesium
Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
Measured: from Week 0 (baseline) to Week 12
Change in Weekly PS Magnesium
Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
Measured: from Week 0 (baseline) to Week 24
Anti-glepaglutide Antibodies
Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56
Measured: Week 56
Reactivity to ZP1848
Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56. Anti-drug antibodies (ADA) positive samples were analyzed for reactivity to ZP1848.
Measured: Week 56
Cross-reactivity to Glucagon-like Peptide-2 (GLP-2)
Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56. ADA positive samples were analyzed for cross-reactivity to glucagon-like peptide-2 (GLP-2).
Measured: Week 56
Glepaglutide Neutralizing Antibodies
Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56
Measured: Week 56

Timeline

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

10 Aug 20215 Sep 2023

First posted5 Aug 2021
Study start10 Aug 2021
Primary completion2 Feb 2023
Study completion5 Sep 2023

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 Short Bowel SyndromeStudies 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
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04991311
Sponsor's protocol ID: ZP1848-20060
Other IDs: 2020-005194-27, U1111-1260-2961
Acronym: EASE SBS 4
Status last verified: Sep 2024
First submitted: 14 Jul 2021
Last updated: 22 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
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

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 3
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Short Bowel Syndrome
Not yet recruitingPhase 2
Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
Enteric Hyperoxaluria
RecruitingPhase 3
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Short Bowel Syndrome
Active, not recruitingObservational study
Registry for Participants With Short Bowel Syndrome
Short Bowel Syndrome

All Short Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center Phase 3b Trial Investigating the Long-term Effect on Intestinal Absorption, Nutritional Status and Long-Term Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome (SBS)
ClinicalTrials.gov ID: NCT04991311
Acronym / sponsor ID: EASE SBS 4 / ZP1848-20060
Conditions: Short Bowel Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Zealand PharmaIndustry (pharma, biotech, devices)
Study start: 10 Aug 2021 (actual)
Primary completion: 2 Feb 2023 (actual)
Study completion: 5 Sep 2023 (actual)
First posted: 5 Aug 2021 (actual)
Results: Posted 22 Nov 2024

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
once-weekly glepaglutide	Experimental	Drug: GlepaglutideAll participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.)

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Age greater than or equal to 18 years and less than or equal to 90 years at screening
Stable condition of SBS either with intestinal failure (SBS-IF) or intestinal insufficiency. For patients with SBS-IF, a stable condition is defined as less than 25 percent change in parenteral support (PS) volume or energy content for 4 weeks prior to screening.
Stable body weight (less than 5 percent change in weight in the 3 months prior to screening)
Wet weight of fecal excretion greater than or equal to 1500 grams per day demonstrated during a hospital stay prior to screening

Key exclusion criteria (7 listed)

More than 2 SBS-related or PS-related hospitalizations (e.g., catheter-related bacteremia/sepsis, bowel obstruction, severe water-electrolytes disturbances, etc.) within 6 months prior to screening
Poorly controlled inflammatory bowel disease (IBD) that is moderately or severely active or fistula interfering with measurements or examinations required in the trial
Current bowel obstruction
Known radiation enteritis or significant villous atrophy, e.g., due to active celiac disease
Cardiac disease defined as: decompensated heart failure (New York Heart Association [NYHA] Class III-IV), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to screening

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
GlepaglutideAlso: ZP1848Glepaglutide will be delivered in a single-use autoinjector.	Drug	once-weekly glepaglutide

Primary outcome

Change in Absorption of Wet Weight/Fluids
Time frame: from Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.

26 secondary outcomes

Change in Absorption of Energy
Time frame: from Week 0 (baseline) to Week 24
Change in Absorption of Carbohydrates
Time frame: from Week 0 (baseline) to Week 24
Change in Absorption of Lipids
Time frame: from Week 0 (baseline) to Week 24
Change in Absorption of Proteins
Time frame: from Week 0 (baseline) to Week 24
Change in Absorption of Sodium
Time frame: from Week 0 (baseline) to Week 24
Change in Absorption of Potassium
Time frame: from Week 0 (baseline) to Week 24
Change in Absorption of Calcium
Time frame: from Week 0 (baseline) to Week 24
Change in Absorption of Magnesium
Time frame: from Week 0 (baseline) to Week 24
Change in Weekly Parenteral Support (PS) Volume
Time frame: from Week 0 (baseline) to Week 12
Change in Weekly PS Volume
Time frame: from Week 0 (baseline) to Week 24
Change in Weekly PS Carbohydrates
Time frame: from Week 0 (baseline) to Week 12
Change in Weekly PS Carbohydrates
Time frame: from Week 0 (baseline) to Week 24
Change in Weekly PS Lipids
Time frame: from Week 0 (baseline) to Week 12
Change in Weekly PS Lipids
Time frame: from Week 0 (baseline) to Week 24
Change in Weekly PS Proteins
Time frame: from Week 0 (baseline) to Week 12
Change in Weekly PS Proteins
Time frame: from Week 0 (baseline) to Week 24
Change in Weekly PS Sodium
Time frame: from Week 0 (baseline) to Week 12
Change in Weekly PS Sodium
Time frame: from Week 0 (baseline) to Week 24
Change in Weekly PS Potassium
Time frame: from Week 0 (baseline) to Week 12
Change in Weekly PS Potassium
Time frame: from Week 0 (baseline) to Week 24
Change in Weekly PS Magnesium
Time frame: from Week 0 (baseline) to Week 12
Change in Weekly PS Magnesium
Time frame: from Week 0 (baseline) to Week 24
Anti-glepaglutide Antibodies
Time frame: Week 56
Reactivity to ZP1848
Time frame: Week 56
Cross-reactivity to Glucagon-like Peptide-2 (GLP-2)
Time frame: Week 56
Glepaglutide Neutralizing Antibodies
Time frame: Week 56

Results and safety

Results posted to the registry on 22 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Once-weekly Glepaglutide	10	9

Primary outcome: Change in Absorption of Wet Weight/Fluids

Time frame: from Week 0 (baseline) to Week 24. Mean (Standard Deviation). Unit: g/day

Measure	Baseline Group - Week 0 n = 10	Week 24 Group n = 10
Value	841.6 (1839.10)	1240.0 (1529.74)

Baseline Group - Week 0 vs Week 24 Group: Mean Difference (Final Values): 398.4 (95% CI -17.6 to 814.4), p = 0.0585, Paired t-test (2-sided, alpha=0.05)

26 secondary outcomes are reported in the full results.

Adverse events

Time frame: Safety data cover the period since the first administrated dose till Week 56.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Once-weekly Glepaglutide	6 of 10 (60%)	10 of 10 (100%)	1 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Short Bowel Syndrome

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 3
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Short Bowel Syndrome
Not yet recruitingPhase 2
Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
Enteric Hyperoxaluria
RecruitingPhase 3
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Short Bowel Syndrome
Active, not recruitingObservational study
Registry for Participants With Short Bowel Syndrome
Short Bowel Syndrome

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.

Zealand Pharma study director

Zealand Pharma

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glepaglutide in people with Short Bowel Syndrome, run by Zealand Pharma at 1 site in Denmark.

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 5 inclusion and 7 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 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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 22 Nov 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?

Change in Absorption of Wet Weight/Fluids (time frame: from Week 0 (baseline) to Week 24). 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 NCT04991311.

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 22 Nov 2024.