Short Bowel SyndromePhase 2STARSnutritionNCT04964986

Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)

A Phase 2 study testing Apraglutide in people with Short Bowel Syndrome, run by VectivBio AG at 2 sites in 2 countries.

Completed

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

Trial summary

The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Short Bowel Syndrome
What is being tested?: Apraglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 2 sitesin 2 countries
Study dates: 14 Jun 2021to 6 Jun 2023
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent for this trial prior to any trial specific assessment.
Male and female subjects with SBS-IF and CIC, receiving parenteral support (PS), secondary to surgical resection of the small intestine with < 200 cm from duodenojejunal flexure.
Subject must require parenteral support (PS) at least 2 days per week and be considered stable.
No restorative surgery intended to change PS requirements in the trial period.
Age ≥ 18 years at screening.

Who cannot join

Pregnancy or lactation.
Body mass index equal or higher than 30 kg/m^2 at the time of screening.
Major abdominal surgery in the last 6 months prior to screening.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Belgium1 site

UZ Leuven
Leuven, 3000

Other trials in Belgium

France1 site

Beaujon Hospital
Clichy, 92110

Other trials in France

About this study

Official title: A Multicenter, Open-label, Metabolic Balance Study to Evaluate the Effects of Apraglutide on Intestinal Absorption in Adult Subjects With Short Bowel Syndrome, Intestinal Failure (SBS-IF), and Colon-in-Continuity (CIC)

The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC.

Read the detailed description

This is an international, multicenter trial to evaluate the safety of apraglutide in adult participants with SBS-IF and CIC. The active pharmaceutical ingredient is apraglutide, an investigational glucagon-like peptide-2 (GLP-2) analogue. The trial consists of an evaluation period of 52 weeks.

Conditions: Short Bowel Syndrome
Being tested: Apraglutide
Keywords: Intestinal Failure, SBS, SBS-IF, CIC, Colon-in-Continuity
Medical subject headings: Short Bowel Syndrome, Intestinal Failure

What participants receive

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

ApraglutideDrug
Also called TA799
Apraglutide is a synthetic peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2.

Study groups in NCT04964986
Study group	Role	What they receive
Apraglutide	Experimental	All participants received apraglutide administered subcutaneously (SC) once weekly for 52 weeks. Receives: Drug: Apraglutide

What is being measured

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

Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE)
A TEAE was any unfavorable and unintended sign, symptom, or disease temporally associated with apraglutide, whether or not related, that occurred or worsened after the dose of apraglutide. A serious TEAE was defined as any TEAE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. Clinically significant changes from baseline in clinical chemistry, hematology, hemostasis, anti-drug antibodies (ADAs), and urine analysis were reported as adverse events.
Adverse events of special interest (AESI) included injection site reaction, gastrointestinal obstruction, gallbladder, biliary, and pancreatic disease, fluid overload, colorectal polyps, malignancies.
Measured: Day 1 up to approximately 55 weeks
Absolute Change in Absorption of Energy Over Metabolic Balance (MB) Periods From Baseline at Week 48
Applicable to Protocol V3.0 implemented in France (classed as secondary endpoint in Protocol V4.0 [implemented in Belgium]).
The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.
Measured: Baseline and Week 48

Secondary outcomes (18)

Relative Change From Baseline in Actual Weekly Parenteral Support (PS) Volume at Weeks 4, 24, and 52
The sum of daily PS volume (including extra fluids) from weekly PS diary data recorded for the corresponding analysis timepoint was used for analysis.
Measured: Baseline, Week 4, Week 24, and Week 52
Absolute Change From Baseline in Actual Weekly PS Volume at Weeks 24 and 52
The sum of daily PS volume (including extra fluids) from weekly PS diary data recorded for the corresponding analysis timepoint was used for analysis.
Measured: Baseline, Week 24 and Week 52
Number of Participants Who Achieved a Reduction of at Least 1 Day Per Week of PS From Baseline at Weeks 24 and 52
Participants were considered to have a reduction of at least one day per week of PS from Baseline (incl. extra fluids) if the number of days with PS from weekly PS diary data recorded for the corresponding analysis timepoint was smaller compared to the number of days with PS from weekly PS diary data for Baseline.
Measured: Baseline, Week 24 and Week 52
Number of Participants Considered Clinical Responders at Weeks 24 and 52
Clinical response was defined as a 20% reduction of PS volume from Baseline. The sum of daily PS volume (including extra fluids) from weekly PS diary data recorded for the corresponding analysis timepoint was used for analysis.
Measured: Baseline, Week 24 and 52
Number of Participants Who Achieved Enteral Autonomy at Weeks 24 and 52
Enteral autonomy was defined as a participant not receiving PS for hydration or parenteral nutrition (PN) for calories. Participants may have still receive minimal fluid to maintain patency of the central line or for specific elemental/micro-nutrient needs (e.g., <100 mL fluid for administration of magnesium).
Measured: Weeks 24 and 52
Absolute Change in Total Energy in PN From Baseline at Weeks 24 and 52
PN was defined as PS that includes protein, carbohydrate, fat, vitamins, and/or trace elements.
Measured: Baseline, Week 24 and Week 52
Relative Change in Absorption of Energy Over MB Periods From Baseline at Week 48
The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.
Measured: Baseline and Week 48
Absolute Change in Absorption of Macronutrients Over MB Periods From Baseline at Weeks 4 and 48
The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.
Measured: Baseline, Week 4 and Week 48
Absolute Change in Urine Volume Over MB Periods From Baseline at Week 4 and Week 48
Based on average daily urine volume data derived as per balance period calculations.
Measured: Baseline, Week 4 and Week 48
Absolute Change in Absorption of Energy Over MB Periods From Baseline at Week 4
The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.
Measured: Baseline and Week 4
Absolute Change in Urinary Electrolytes Over MB Periods From Baseline at Week 4 and Week 48
Since urinary electrolytes data were measured over the 72-hour MB period, the average of all available results were used for analyses for each MB parameter at a given analysis time point.
Measured: Baseline, Week 4 and Week 48
Change From Baseline in Pittsburgh Sleep Quality Inventory (PSQI) Total Score at Week 24 and Week 52
The PSQI is a patient-reported questionnaire used to measure the quality and patterns of sleep, over the past month. The PSQI has seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. Minimum Score = 0 (better); Maximum Score = 21 (worse). A negative change from baseline represents an reduction in symptoms.
Measured: Baseline, Week 24 and Week 52
Change From Baseline in Patient Global Impression of Change (PGIC) at Week 24 and Week 52
PGIC v2.0 is a single-item questionnaire using a 5-point verbal rating scale, to assess overall change in the participants status after taking the study drug. Response options range from 2= very much better to -2= very much worse.
Measured: Baseline, Week 24 and Week 52
Secondary: Patient Global Impression of Treatment Satisfaction (PGI-TS) at Week 24 and Week 52
This form is a single-item questionnaire assessing the participant's satisfaction with the trial medication over the preceding 7 days. Response options range from -2 to 2, very dissatisfied to very satisfied.
Measured: Week 24 and Week 52
Change From Baseline in Patient Global Impression of Satisfaction With Parenteral Support (PGI-SPS) at Week 24 and Week 52
This is a single-item questionnaire assessing the participant's satisfaction with PS over the preceding 7 days. Response options range from -2 to 2, very dissatisfied to very satisfied. A reduction from baseline represents a decrease in satisfaction.
Measured: Baseline, Week 24 and Week 52
Change From Baseline in Patient Global Impression of Parenteral Support Impact (PGI-PSI) at Week 24 and Week 52
This is a three-item questionnaire assessing the impact of PS on the participant's sleep, daily activities, and quality of life (QoL) over the past 7 days. All questions have response options ranging from 0 to 4, not at all to extremely. A reduction from baseline represents a decrease in symptoms.
Measured: Baseline, Week 24 and Week 52
Trough Apraglutide Plasma Concentration (Ctrough)
Measured: Pre-dose on Weeks 2, 4, 12, 24, 32, 40, 48, and 52
Mean Plasma Citrulline Level
Measured: Baseline and Weeks 2, 4, 12, 24, 32, 40, 48, and 52

Timeline

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

14 Jun 20216 Jun 2023

First posted16 Jul 2021
Study start14 Jun 2021
Primary completion6 Jun 2023
Study completion6 Jun 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.
Publications (2)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04964986
Sponsor's protocol ID: TA799-013
Other IDs: 2020-005129-99
Acronym: STARSnutrition
Status last verified: Jun 2025
First submitted: 27 May 2021
Last updated: 18 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Ekhlas D, Verbiest A, Stas M, De Meyere L, Vandermeulen G, Toth J, Geboers K, Timmermans L, Verspecht C, Wauters L, Vermeersch P, Jeppesen PB, Verbeke K, Joly F, Derrien M, Raes J, Vanuytsel T. Early ecological changes in intestinal microbiota with the long-acting GLP-2 analog apraglutide in short bowel syndrome. Clin Nutr ESPEN. 2026 Jun;73:103138. doi: 10.1016/j.clnesp.2026.103138. Epub 2026 Mar 26.
PubMed 41903849
Verbiest A, Hvistendahl MK, Bolognani F, Li C, Youssef NN, Huh S, Menys A, Bhatnagar G, Vanslembrouck R, Peeters R, Sartoris R, Vermeersch P, Wauters L, Verbeke K, Jeppesen PB, Joly F, Vanuytsel T. Efficacy and safety of apraglutide in short bowel syndrome with intestinal failure and colon-in-continuity: A multicenter, open-label, metabolic balance study. Clin Nutr. 2024 Dec;43(12):158-166. doi: 10.1016/j.clnu.2024.10.011. Epub 2024 Oct 16.
PubMed 39461299

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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All Short Bowel Syndrome trials

Study at a glance

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

Official title: A Multicenter, Open-label, Metabolic Balance Study to Evaluate the Effects of Apraglutide on Intestinal Absorption in Adult Subjects With Short Bowel Syndrome, Intestinal Failure (SBS-IF), and Colon-in-Continuity (CIC)
ClinicalTrials.gov ID: NCT04964986
Acronym / sponsor ID: STARSnutrition / TA799-013
Conditions: Short Bowel Syndrome
Keywords: Intestinal Failure, SBS, SBS-IF, CIC, Colon-in-Continuity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: VectivBio AGIndustry (pharma, biotech, devices)
Study start: 14 Jun 2021 (actual)
Primary completion: 6 Jun 2023 (actual)
Study completion: 6 Jun 2023 (actual)
First posted: 16 Jul 2021 (actual)
Results: Posted 18 Jun 2025

Clinical summary

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

The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC.

Detailed description

Study design

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

Arm	Type	Receives
Apraglutide	Experimental	Drug: ApraglutideAll participants received apraglutide administered subcutaneously (SC) once weekly for 52 weeks.

Who may qualify

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

Key inclusion criteria (5 listed)

Signed informed consent for this trial prior to any trial specific assessment.
Male and female subjects with SBS-IF and CIC, receiving parenteral support (PS), secondary to surgical resection of the small intestine with < 200 cm from duodenojejunal flexure.
Subject must require parenteral support (PS) at least 2 days per week and be considered stable.
No restorative surgery intended to change PS requirements in the trial period.
Age ≥ 18 years at screening.

Key exclusion criteria (3 listed)

Pregnancy or lactation.
Body mass index equal or higher than 30 kg/m^2 at the time of screening.
Major abdominal surgery in 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
ApraglutideAlso: TA799Apraglutide is a synthetic peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2.	Drug	Apraglutide

Primary outcome

Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE)
Time frame: Day 1 up to approximately 55 weeks
A TEAE was any unfavorable and unintended sign, symptom, or disease temporally associated with apraglutide, whether or not related, that occurred or worsened after the dose of apraglutide. A serious TEAE was defined as any TEAE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. Clinically significant changes from baseline in clinical chemistry, hematology, hemostasis, anti-drug antibodies (ADAs), and urine analysis were reported as adverse events. Adverse events of special interest (AESI) included injection site reaction, gastrointestinal obstruction, gallbladder, biliary, and pancreatic disease, fluid overload, colorectal polyps, malignancies.
Absolute Change in Absorption of Energy Over Metabolic Balance (MB) Periods From Baseline at Week 48
Time frame: Baseline and Week 48
Applicable to Protocol V3.0 implemented in France (classed as secondary endpoint in Protocol V4.0 [implemented in Belgium]). The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.

18 secondary outcomes

Relative Change From Baseline in Actual Weekly Parenteral Support (PS) Volume at Weeks 4, 24, and 52
Time frame: Baseline, Week 4, Week 24, and Week 52
Absolute Change From Baseline in Actual Weekly PS Volume at Weeks 24 and 52
Time frame: Baseline, Week 24 and Week 52
Number of Participants Who Achieved a Reduction of at Least 1 Day Per Week of PS From Baseline at Weeks 24 and 52
Time frame: Baseline, Week 24 and Week 52
Number of Participants Considered Clinical Responders at Weeks 24 and 52
Time frame: Baseline, Week 24 and 52
Number of Participants Who Achieved Enteral Autonomy at Weeks 24 and 52
Time frame: Weeks 24 and 52
Absolute Change in Total Energy in PN From Baseline at Weeks 24 and 52
Time frame: Baseline, Week 24 and Week 52
Relative Change in Absorption of Energy Over MB Periods From Baseline at Week 48
Time frame: Baseline and Week 48
Absolute Change in Absorption of Macronutrients Over MB Periods From Baseline at Weeks 4 and 48
Time frame: Baseline, Week 4 and Week 48
Absolute Change in Urine Volume Over MB Periods From Baseline at Week 4 and Week 48
Time frame: Baseline, Week 4 and Week 48
Absolute Change in Absorption of Energy Over MB Periods From Baseline at Week 4
Time frame: Baseline and Week 4
Absolute Change in Urinary Electrolytes Over MB Periods From Baseline at Week 4 and Week 48
Time frame: Baseline, Week 4 and Week 48
Change From Baseline in Pittsburgh Sleep Quality Inventory (PSQI) Total Score at Week 24 and Week 52
Time frame: Baseline, Week 24 and Week 52
Change From Baseline in Patient Global Impression of Change (PGIC) at Week 24 and Week 52
Time frame: Baseline, Week 24 and Week 52
Secondary: Patient Global Impression of Treatment Satisfaction (PGI-TS) at Week 24 and Week 52
Time frame: Week 24 and Week 52
Change From Baseline in Patient Global Impression of Satisfaction With Parenteral Support (PGI-SPS) at Week 24 and Week 52
Time frame: Baseline, Week 24 and Week 52
Change From Baseline in Patient Global Impression of Parenteral Support Impact (PGI-PSI) at Week 24 and Week 52
Time frame: Baseline, Week 24 and Week 52
Trough Apraglutide Plasma Concentration (Ctrough)
Time frame: Pre-dose on Weeks 2, 4, 12, 24, 32, 40, 48, and 52
Mean Plasma Citrulline Level
Time frame: Baseline and Weeks 2, 4, 12, 24, 32, 40, 48, and 52

Results and safety

Results posted to the registry on 18 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Apraglutide SC Injections, Once Weekly	9	9

Primary outcome: Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE)

Time frame: Day 1 up to approximately 55 weeks. Count of participants. Unit: Participants

Measure	Apraglutide SC Injections, Once Weekly n = 9
At least one TEAE	9
At least one treatment-related TEAE	5
At least one TESAE	3
At least one treatment-related TESAE	1
At least one treatment-emergent AESI	3
At least one TEAE leading to dose interruption	1
At least one TEAE leading to permanent dose discontinuation	0

Primary outcome: Absolute Change in Absorption of Energy Over Metabolic Balance (MB) Periods From Baseline at Week 48

Time frame: Baseline and Week 48. Mean (Standard Deviation). Unit: kJ/day

Measure	Apraglutide SC Injections, Once Weekly n = 9
Value	1133.963 (1399.8793)

Apraglutide SC Injections, Once Weekly: p = 0.041, paired t-test

Population analysed: The full analysis set included all participants who received at least one dose of trial treatment and contributed at least one valid post-baseline efficacy point.

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to approximately 55 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Apraglutide SC Injections, Once Weekly	3 of 9 (33.3%)	9 of 9 (100%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41903849Ekhlas D, Verbiest A, Stas M, De Meyere L, Vandermeulen G, Toth J, Geboers K, Timmermans L, Verspecht C, Wauters L, Vermeersch P, Jeppesen PB, Verbeke K, Joly F, Derrien M, Raes J, Vanuytsel T. Early ecological changes in intestinal microbiota with the long-acting GLP-2 analog apraglutide in short bowel syndrome. Clin Nutr ESPEN. 2026 Jun;73:103138. doi: 10.1016/j.clnesp.2026.103138. Epub 2026 Mar 26.
Derived from this study: PubMed 39461299Verbiest A, Hvistendahl MK, Bolognani F, Li C, Youssef NN, Huh S, Menys A, Bhatnagar G, Vanslembrouck R, Peeters R, Sartoris R, Vermeersch P, Wauters L, Verbeke K, Jeppesen PB, Joly F, Vanuytsel T. Efficacy and safety of apraglutide in short bowel syndrome with intestinal failure and colon-in-continuity: A multicenter, open-label, metabolic balance study. Clin Nutr. 2024 Dec;43(12):158-166. doi: 10.1016/j.clnu.2024.10.011. Epub 2024 Oct 16.

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
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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.

Tomasz Masior study director

VectivBio AG

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apraglutide in people with Short Bowel Syndrome, run by VectivBio AG at 2 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 5 inclusion and 3 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 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium, France. 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 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?

Yes. Results are posted in the registry (first posted 18 Jun 2025). 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 Who Experienced a Treatment-Emergent Adverse Event (TEAE) (time frame: Day 1 up to approximately 55 weeks). 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 NCT04964986, which also lists 2 linked publications.

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 Jun 2025.