Chronic Intestinal Pseudo-obstructionPhase 2NCT05724069
Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction (CIPO).
A Phase 2 study testing Velusetrag 15 mg once daily for 4 weeks. in people with Chronic Intestinal Pseudo-obstruction, run by Alfasigma S.p.A. at 4 sites in 3 countries.
Trial summary
This is a phase II, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of velusetrag once a day, compared to placebo, in subjects with CIPO. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Intestinal Pseudo-obstruction
- What is being tested?
- Velusetrag 15 mg once daily for 4 weeks.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 15 Dec 2021to 12 Apr 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with history of chronic idiopathic intestinal pseudo-obstruction or CIPO secondary to neurodegenerative or demyelinating disease.
- Subjects with estimated oral caloric intake of at least 30% of the daily age- and sex-recommended caloric intake.
- Subjects with at least 2 out of 4 CIPO gastrointestinal symptoms each of the 2 with a score ≥3 (on a 0 to 4 scale) at Day -1
- Subjects accepting to provide and legally capable of providing free and informed consent to all procedures included in the protocol.
- All sexually active male participants who are partner of women of childbearing potential must use condom during intercourse until the 90th day after the end of the entire study.
- Female participants are eligible if they are: i) of non-childbearing potential or ii) of childbearing potential with a negative pregnancy test result at screening and randomization AND agreeing to use a highly effective method of contraception (i.e., with failure rate of less than 1% per year) until the end of the entire study.
Who cannot join
- Subjects with primary CIPO or CIPO secondary to other known endocrine/metabolic, autoimmune diseases and neurologic conditions other than neurodegenerative or demyelinating diseases.
- Subjects with conditions characterized by mechanical intestinal obstruction.
- Nasogastric tube, gastrostomy tube, or jejunostomy feeding tube in place at randomization or planned throughout the duration of the study, or artificial food need scale stage 3.
- Presence of untreated clinically relevant thyroid dysfunction or known thyroid dysfunction not well controlled by treatment deemed clinically significant by the Investigator.
- Subjects with history of diabetes at screening.
- Clinically significant ECG abnormalities at screening and randomization.
Show all 26Show fewer
- Screening ECG with a QTcF >450 msec in males or >470 msec in females or family history of sudden cardiac death.
- Subjects requiring a low galactose diet.
- Hypersensitivity or documented intolerance to lactulose, lactose or any excipient of the lactulose preparation to be used for L-BT.
- History of sensitivity to velusetrag, or any of the velusetrag or placebo excipients.
- Use of scopolamine or erythromycin within 2 weeks prior to screening and/or planned throughout the duration of the study.
- Use of 5-HT4 receptor agonists within 5 days prior to randomization and/or planned throughout the duration of the study
- Use of opioids within 8 weeks from screening and/or planned throughout the duration of the study.
- Received strong cytochrome P450-isozyme 3A4 (CYP3A4) inhibitors within 2 weeks prior to screening and/or planned throughout the duration of the study.
- Received strong P-glycoprotein (P-gp) transporter inhibitors within 2 weeks prior to Screening and/or planned throughout the duration of the study.
- Received strong breast cancer resistance protein transporter inhibitors within 2 weeks prior to screening and/or planned throughout the duration of the study.
- Current swab-positive or suspected (under investigation) COVID-19 infection.
- Cancer (excluding non-melanoma skin cancer) and/or need of any anti-cancer treatment (also including radiotherapy) within the last 5 years.
- Severe kidney impairment.
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) levels >2.5 times the upper limit of normal (ULN); bilirubin (unless deemed to be due to Gilbert's Syndrome) or alkaline phosphatase (ALP) >1.5 times ULN.
- Severe hepatic impairment defined as Child-Pugh C.
- History of any of the following cardiac disorders: i) torsade de pointes, ventricular tachycardia, ventricular fibrillation; ii) previous myocardial infarction, unstable angina pectoris, acute coronary syndrome, coronary artery or cerebral revascularization procedure or stroke within the previous 18 months; iii) angina pectoris class 2-4 during the last 12 months prior to screening; iv) congestive heart failure NYHA class III-IV during the last 18 months prior to screening.
- History of any alcohol or drug abuse or dependence within the last year (Investigator's judgement).
- Any current significant health condition that in the Investigator's judgement may: i) jeopardize the patient's safe participation in the trial or ii) make unlikely the patient's completion of the study or iii) make unlikely the patient's compliance with the study procedures.
- Pregnant or breastfeeding woman.
- Use of any experimental drug within 12 weeks prior to screening
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Italy2 sites
Policlinico S.Orsola-Malpighi
Bologna, 40128
Aou Arcispedale Sant'Anna Di Cona
Cona, 30010
About this study
Official title: Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction (CIPO). A Multicenter, Double-blind, Placebo-controlled, Cross-over, Multiple (n=1) Trial.
This is a phase II, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of velusetrag once a day, compared to placebo, in subjects with CIPO.
- Conditions
- Chronic Intestinal Pseudo-obstruction
- Being tested
- Velusetrag 15 mg once daily for 4 weeks., Placebo once daily for 4 weeks.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Velusetrag 15 mg once daily for 4 weeks.Drug
Subjects will be randomly allocated in a blinded fashion to 1 out of the 4 treatment sequences (each sequence include 4 periods, 2 periods with velusetrag and 2 periods with placebo). There will be a wash-out period between each treatment period.
Placebo once daily for 4 weeks.Drug
Subjects will be randomly allocated in a blinded fashion to 1 out of the 4 treatment sequences (each sequence include 4 periods, 2 periods with velusetrag and 2 periods with placebo). There will be a wash-out period between each treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Other | Eligible subjects will be treated for 4 periods with either velusetrag 15 mg once a day (2 periods) or placebo (2 periods), with a wash-out period of 2 weeks between treatment periods.
The progression order of this sequence is: velusetrag first intervention 4 weeks, 2 weeks of wash-out period, then second intervention of placebo for 4 weeks, 2 weeks of wash-out period, then third intervention of velusetrag for other 4 weeks, 2 weeks of wash-out period and last 4 weeks of placebo as fourth intervention. Receives: Drug: Velusetrag 15 mg once daily for 4 weeks.; Drug: Placebo once daily for 4 weeks. |
| Sequence B | Other | Eligible subjects will be treated for 4 periods with either velusetrag 15 mg once a day (2 periods) or placebo (2 periods), with a wash-out period of 2 weeks between treatment periods.
The progression order of this sequence is: placebo first intervention 4 weeks, 2 weeks of wash-out period, then second intervention of velusetrag for 4 weeks, 2 weeks of wash-out period, then third intervention of placebo for other 4 weeks, 2 weeks of wash-out period and last 4 weeks of velusetrag as fourth intervention. Receives: Drug: Velusetrag 15 mg once daily for 4 weeks.; Drug: Placebo once daily for 4 weeks. |
| Sequence C | Other | Eligible subjects will be treated for 4 periods with either velusetrag 15 mg once a day (2 periods) or placebo (2 periods), with a wash-out period of 2 weeks between treatment periods.
The progression order of this sequence is: velusetrag first intervention 4 weeks, 2 weeks of wash-out period, then second intervention of placebo for 4 weeks, 2 weeks of wash-out period, then third intervention of placebo for other 4 weeks, 2 weeks of wash-out period and last 4 weeks of velusetrag as fourth intervention. Receives: Drug: Velusetrag 15 mg once daily for 4 weeks.; Drug: Placebo once daily for 4 weeks. |
| Sequence D | Other | Eligible subjects will be treated for 4 periods with either velusetrag 15 mg once a day (2 periods) or placebo (2 periods), with a wash-out period of 2 weeks between treatment periods.
The progression order of this sequence is: placebo first intervention 4 weeks, 2 weeks of wash-out period, then second intervention of velusetrag for 4 weeks, 2 weeks of wash-out period, then third intervention of velusetrag for other 4 weeks, 2 weeks of wash-out period and last 4 weeks of placebo as fourth intervention. Receives: Drug: Velusetrag 15 mg once daily for 4 weeks.; Drug: Placebo once daily for 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Weekly Global Gastrointestinal Symptoms Average Index Score (WGGSAIS).
Mean change in weekly global gastrointestinal symptoms average index score (WGGSAIS) from pretreatment (PRE) to the end of each treatment period (EOT). The weekly global gastrointestinal symptoms average index score is obtained by averaging the scores for each of the 4 symptoms, abdominal pain, bloating, nausea and vomiting, assessed using a subject's e-diary. Each symptom was rated using a recall period of 7 days and a Likert scale with the following categories: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe according to its influence on usual activity. The WGGSAIS thus ranges between 0 and 4 with lower scores representing better health.
Measured: 4 weeks. The change is derived as the end of treatment period minus the pre-treatment value of the period, for each period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start15 Dec 2021
- Primary completion12 Apr 2023
- Study completion12 Apr 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 (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Intestinal Pseudo-obstructionStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alfasigma S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724069
- Sponsor's protocol ID
- VE-CIP2001/2021
- Status last verified
- Jul 2025
- First submitted
- 2 Feb 2023
- Last updated
- 3 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Malagelada C, De Giorgio R, Cogliandro RF, Alcala-Gonzalez L, Costanzini A, Scuderi V, Manzoni S, Pasquali E, Tack J, Stanghellini V. Clinical Trial: Efficacy and Safety of Velusetrag in Chronic Intestinal Pseudo-Obstruction: A Randomized, Phase 2, Placebo-Controlled, Crossover, Multiple (n = 1), Proof-of-Concept Study. Neurogastroenterol Motil. 2026 Jan;38(1):e70246. doi: 10.1111/nmo.70246.
PubMed 41553253
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction (CIPO). A Multicenter, Double-blind, Placebo-controlled, Cross-over, Multiple (n=1) Trial.
- ClinicalTrials.gov ID
- NCT05724069
- Acronym / sponsor ID
- VE-CIP2001/2021
- Conditions
- Chronic Intestinal Pseudo-obstruction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Alfasigma S.p.A.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Posted 3 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of velusetrag once a day, compared to placebo, in subjects with CIPO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Other | Drug: Velusetrag 15 mg once daily for 4 weeks., Drug: Placebo once daily for 4 weeks.Eligible subjects will be treated for 4 periods with either velusetrag 15 mg once a day (2 periods) or placebo (2 periods), with a wash-out period of 2 weeks between treatment periods. The progression order of this sequence is: velusetrag first intervention 4 weeks, 2 weeks of wash-out period, then second intervention of placebo for 4 weeks, 2 weeks of wash-out period, then third intervention of velusetrag for other 4 weeks, 2 weeks of wash-out period and last 4 weeks of placebo as fourth intervention. |
| Sequence B | Other | Drug: Velusetrag 15 mg once daily for 4 weeks., Drug: Placebo once daily for 4 weeks.Eligible subjects will be treated for 4 periods with either velusetrag 15 mg once a day (2 periods) or placebo (2 periods), with a wash-out period of 2 weeks between treatment periods. The progression order of this sequence is: placebo first intervention 4 weeks, 2 weeks of wash-out period, then second intervention of velusetrag for 4 weeks, 2 weeks of wash-out period, then third intervention of placebo for other 4 weeks, 2 weeks of wash-out period and last 4 weeks of velusetrag as fourth intervention. |
| Sequence C | Other | Drug: Velusetrag 15 mg once daily for 4 weeks., Drug: Placebo once daily for 4 weeks.Eligible subjects will be treated for 4 periods with either velusetrag 15 mg once a day (2 periods) or placebo (2 periods), with a wash-out period of 2 weeks between treatment periods. The progression order of this sequence is: velusetrag first intervention 4 weeks, 2 weeks of wash-out period, then second intervention of placebo for 4 weeks, 2 weeks of wash-out period, then third intervention of placebo for other 4 weeks, 2 weeks of wash-out period and last 4 weeks of velusetrag as fourth intervention. |
| Sequence D | Other | Drug: Velusetrag 15 mg once daily for 4 weeks., Drug: Placebo once daily for 4 weeks.Eligible subjects will be treated for 4 periods with either velusetrag 15 mg once a day (2 periods) or placebo (2 periods), with a wash-out period of 2 weeks between treatment periods. The progression order of this sequence is: placebo first intervention 4 weeks, 2 weeks of wash-out period, then second intervention of velusetrag for 4 weeks, 2 weeks of wash-out period, then third intervention of velusetrag for other 4 weeks, 2 weeks of wash-out period and last 4 weeks of placebo as fourth intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with history of chronic idiopathic intestinal pseudo-obstruction or CIPO secondary to neurodegenerative or demyelinating disease.
- Subjects with estimated oral caloric intake of at least 30% of the daily age- and sex-recommended caloric intake.
- Subjects with at least 2 out of 4 CIPO gastrointestinal symptoms each of the 2 with a score ≥3 (on a 0 to 4 scale) at Day -1
- Subjects accepting to provide and legally capable of providing free and informed consent to all procedures included in the protocol.
- All sexually active male participants who are partner of women of childbearing potential must use condom during intercourse until the 90th day after the end of the entire study.
Key exclusion criteria (26 listed)
- Subjects with primary CIPO or CIPO secondary to other known endocrine/metabolic, autoimmune diseases and neurologic conditions other than neurodegenerative or demyelinating diseases.
- Subjects with conditions characterized by mechanical intestinal obstruction.
- Nasogastric tube, gastrostomy tube, or jejunostomy feeding tube in place at randomization or planned throughout the duration of the study, or artificial food need scale stage 3.
- Presence of untreated clinically relevant thyroid dysfunction or known thyroid dysfunction not well controlled by treatment deemed clinically significant by the Investigator.
- Subjects with history of diabetes at 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 |
|---|---|---|
| Velusetrag 15 mg once daily for 4 weeks.Subjects will be randomly allocated in a blinded fashion to 1 out of the 4 treatment sequences (each sequence include 4 periods, 2 periods with velusetrag and 2 periods with placebo). There will be a wash-out period between each treatment period. | Drug | Sequence A, Sequence B, Sequence C, Sequence D |
| Placebo once daily for 4 weeks.Subjects will be randomly allocated in a blinded fashion to 1 out of the 4 treatment sequences (each sequence include 4 periods, 2 periods with velusetrag and 2 periods with placebo). There will be a wash-out period between each treatment period. | Drug | Sequence A, Sequence B, Sequence C, Sequence D |
Primary outcome
Mean Change in Weekly Global Gastrointestinal Symptoms Average Index Score (WGGSAIS).
Time frame: 4 weeks. The change is derived as the end of treatment period minus the pre-treatment value of the period, for each period.
Mean change in weekly global gastrointestinal symptoms average index score (WGGSAIS) from pretreatment (PRE) to the end of each treatment period (EOT). The weekly global gastrointestinal symptoms average index score is obtained by averaging the scores for each of the 4 symptoms, abdominal pain, bloating, nausea and vomiting, assessed using a subject's e-diary. Each symptom was rated using a recall period of 7 days and a Likert scale with the following categories: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe according to its influence on usual activity. The WGGSAIS thus ranges between 0 and 4 with lower scores representing better health.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41553253Malagelada C, De Giorgio R, Cogliandro RF, Alcala-Gonzalez L, Costanzini A, Scuderi V, Manzoni S, Pasquali E, Tack J, Stanghellini V. Clinical Trial: Efficacy and Safety of Velusetrag in Chronic Intestinal Pseudo-Obstruction: A Randomized, Phase 2, Placebo-Controlled, Crossover, Multiple (n = 1), Proof-of-Concept Study. Neurogastroenterol Motil. 2026 Jan;38(1):e70246. doi: 10.1111/nmo.70246.
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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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Velusetrag 15 mg once daily for 4 weeks. in people with Chronic Intestinal Pseudo-obstruction, run by Alfasigma S.p.A. at 4 sites in 3 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 6 inclusion and 26 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 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Belgium, Spain. 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 3 Aug 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?
Mean Change in Weekly Global Gastrointestinal Symptoms Average Index Score (WGGSAIS). (time frame: 4 weeks. The change is derived as the end of treatment period minus the pre-treatment value of the period, for each period.). 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 NCT05724069, which also lists 1 linked publication.
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 3 Aug 2025.