AchalasiaPhase 2NCT02931565

Study of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Type I or II Achalasia

A Phase 2 study testing Olinciguat in people with Achalasia, run by Cyclerion Therapeutics at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The objectives of this study are as follows: In participants with primary Type I or II achalasia, following a single 5-mg dose of olinciguat (IW-1701), To assess the safety and tolerability To determine the effects on measures of esophageal function by high-resolution impedance manometry (HRIM) To determine the… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Achalasia
What is being tested?: Olinciguat
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 9 participants
Where: 5 sitesUnited States
Study dates: 6 Apr 2017to 1 May 2018
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has a diagnosis of primary Type I or II achalasia.
Patient has no contraindications to the performance of the baseline and postdose HRIM procedures per Investigator discretion.

Who cannot join

Patient has had any prior esophageal, periesophageal, or gastric surgery, or treatment with sclerosing agent.
More than 1 pneumatic dilation procedure to a diameter of > 2 cm in their lifetime.
Pneumatic dilation procedure to a diameter of > 2 cm within 1 year prior to randomization. Prior bougie dilation(s) or pneumatic dilation(s) ≤ 2 cm are allowed.
Prior esophageal injection of botulinum toxin (Botox) within 6 months prior to randomization or more than 2 esophageal Botox injection procedures in their lifetime.
Patients with malignant or premalignant esophageal lesions.
Patient has taken any drug that can affect gastrointestinal (GI) motility in the 72 hours before check-in through discharge from the clinic.
Other inclusion and exclusion criteria specified in the protocol.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Connecticut Clinical Research Foundation, Gastroenterology Institute
Bristol, Connecticut, 06010
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah School of Medicine, Division of Gastroenterology, Hepatology & Nutrition
Salt Lake City, Utah, 84132
Washington University in St. Louis - School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Single-dose, Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 in Patients With Achalasia

The objectives of this study are as follows:

In participants with primary Type I or II achalasia, following a single 5-mg dose of olinciguat (IW-1701),

To assess the safety and tolerability
To determine the effects on measures of esophageal function by high-resolution impedance manometry (HRIM)
To determine the pharmacokinetic (PK) parameters

Conditions: Achalasia
Being tested: Olinciguat, Matching Placebo
Medical subject headings: Esophageal Achalasia

What participants receive

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

OlinciguatDrug
Also called IW-1701
oral tablet
Matching PlaceboDrug
oral tablet

Study groups in NCT02931565
Study group	Role	What they receive
IW-1701	Experimental	Single 5-mg dose of IW-1701 administered orally Receives: Drug: Olinciguat
Placebo	Placebo comparator	Matching placebo administered orally Receives: Drug: Matching Placebo

What is being measured

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

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs)
An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with study treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: death; life-threatening: the patient was at immediate risk of death from the reaction as it occurred; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical event. Deaths and SAEs include those that occurred on or after the participant signed the informed consent at the Screening Visit through the End-of-Trial Visit. TEAEs are defined as adverse events that occurred on/after administration of the double-blind study drug and within 72 hours after the double-blind study drug administration.
Measured: Deaths, SAEs, and AEs: from enrollment through end-of-trial visit Day 21 (±7 days). TEAEs: from first dose of study drug through 72 hours postdose.
Change From Baseline in Supine Bolus Flow Time (BFT)
Supine BFT defined as the median measurement from the 10 available swallows in supine position as measured by high resolution impedance manometry (HRIM), and determined by the central read (seconds; longer times=more severe achalasia). Change=(postdose supine BFT - predose supine BFT).
Measured: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Change From Baseline in Upright BFT
Upright BFT defined as the median measurement from the 5 available swallows in the upright position as measured by HRIM, and determined by the central read (seconds; longer times=more severe achalasia). Change = (postdose upright BFT - predose upright BFT).
Measured: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Change From Baseline in Supine Integrated Relaxation Pressure (IRP)
Supine IRP defined as the median measurement from the 10 available swallows in supine position as determined by the central read (mmHg; higher pressure=more severe achalasia), measured by HRIM. Change = (postdose supine IRP - predose supine IRP).
Measured: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Change From Baseline in Upright IRP
Upright IRP is defined as the median measurement from the 5 available swallows in the supine position as determined by the central read (mmHg; higher pressure=more severe achalasia), measured by HRIM. Change = (postdose upright IRP - predose upright IRP).
Measured: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Change From Baseline in 1 Minute Impedance Bolus Height (IBH)
1 minute IBH defined by the height in esophagus of 200 mL saline bolus 1 minute post-bolus as measured by HRIM and determined by the central read (cm; greater height=more severe achalasia). Change = (postdose height 1 min IBH - predose height 1 min IBH)
Measured: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Change From Baseline in 2 Minute IBH
2 minute IBH defined by the height in esophagus of 200 mL saline bolus 2 minutes post-bolus as measured by HRIM and determined by the central read (cm; greater height=more severe achalasia). Change = (postdose height 2 min IBH - predose height 2 min IBH).
Measured: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Change From Baseline in 5 Minute IBH
5 minute IBH defined by the height in esophagus of 200 mL saline bolus 5 minutes post-bolus as determined by the central read (cm; greater height=more severe achalasia). Change = (postdose height 5 min IBH - predose height 5 min IBH).
Measured: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Area Under the Plasma Concentration Time Curve From Time 0 to the Last Observation (AUClast)
Measured: Day 1 predose: 0 (≤15 minutes); Day 1 postdose: 0.5 hours (±2 minutes), 1, 2, 3, 4, 5, 6, 8 hours (±5 minutes), 12, 17 hours (±15 minutes). Day 2 postdose 24 hours (±30 minutes). End of Treatment Visit: Day 21 (±7 days).
Maximum Observed Plasma Concentration (Cmax)
Measured: Day 1 predose: 0 (≤15 minutes); Day 1 postdose: 0.5 hours (±2 minutes), 1, 2, 3, 4, 5, 6, 8 hours (±5 minutes), 12, 17 hours (±15 minutes). Day 2 postdose 24 hours (±30 minutes). End of Treatment Visit: Day 21 (±7 days).
Time of Maximum Observed Plasma Concentration (Tmax)
Measured: Day 1 predose: 0 (≤15 minutes); Day 1 postdose: 0.5 hours (±2 minutes), 1, 2, 3, 4, 5, 6, 8 hours (±5 minutes), 12, 17 hours (±15 minutes). Day 2 postdose 24 hours (±30 minutes). End of Treatment Visit: Day 21 (±7 days).

Timeline

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

6 Apr 20171 May 2018

First posted13 Oct 2016 (estimated)
Study start6 Apr 2017
Primary completion1 May 2018
Study completion1 May 2018

Why it stopped: The study was prematurely terminated due to enrollment challenges.

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 AchalasiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02931565
Sponsor's protocol ID: C1701-201
Status last verified: Apr 2021
First submitted: 11 Oct 2016
Last updated: 4 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

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
RecruitingPhase 2
Full-thickness Versus Progressive Myotomy in Peroral Endoscopic Esophageal Myotomy in Achalasia: A Randomized Controlled Trial
Achalasia Cardia, Achalasia
RecruitingPhase 3
PREcision MEDicine In Achalasia (PREMEDIA)
Type I Achalasia, Type II Achalasia
RecruitingObservational study
PREcision MEDicine In Achalasia (PREMEDIA) - Cohort
Type III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features
RecruitingPhase 4
VZV in the Enteric Nervous System: Pathogenesis and Consequences
Achalasia

All Achalasia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Single-dose, Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 in Patients With Achalasia
ClinicalTrials.gov ID: NCT02931565
Acronym / sponsor ID: C1701-201
Conditions: Achalasia
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was prematurely terminated due to enrollment challenges.
Enrolment: 9 participants (actual)
Lead sponsor: Cyclerion TherapeuticsIndustry (pharma, biotech, devices)
Study start: 6 Apr 2017 (actual)
Primary completion: 1 May 2018 (actual)
Study completion: 1 May 2018 (actual)
First posted: 13 Oct 2016 (estimated)
Results: Posted 4 May 2021

Clinical summary

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

The objectives of this study are as follows:

In participants with primary Type I or II achalasia, following a single 5-mg dose of olinciguat (IW-1701),

To assess the safety and tolerability
To determine the effects on measures of esophageal function by high-resolution impedance manometry (HRIM)
To determine the pharmacokinetic (PK) parameters

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
IW-1701	Experimental	Drug: OlinciguatSingle 5-mg dose of IW-1701 administered orally
Placebo	Placebo comparator	Drug: Matching PlaceboMatching placebo administered orally

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patient has a diagnosis of primary Type I or II achalasia.
Patient has no contraindications to the performance of the baseline and postdose HRIM procedures per Investigator discretion.

Key exclusion criteria (7 listed)

Patient has had any prior esophageal, periesophageal, or gastric surgery, or treatment with sclerosing agent.
More than 1 pneumatic dilation procedure to a diameter of > 2 cm in their lifetime.
Pneumatic dilation procedure to a diameter of > 2 cm within 1 year prior to randomization. Prior bougie dilation(s) or pneumatic dilation(s) ≤ 2 cm are allowed.
Prior esophageal injection of botulinum toxin (Botox) within 6 months prior to randomization or more than 2 esophageal Botox injection procedures in their lifetime.
Patients with malignant or premalignant esophageal lesions.

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
OlinciguatAlso: IW-1701oral tablet	Drug	IW-1701
Matching Placebooral tablet	Drug	Placebo

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs)
Time frame: Deaths, SAEs, and AEs: from enrollment through end-of-trial visit Day 21 (±7 days). TEAEs: from first dose of study drug through 72 hours postdose.
An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with study treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: death; life-threatening: the patient was at immediate risk of death from the reaction as it occurred; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical event. Deaths and SAEs include those that occurred on or after the participant signed the informed consent at the Screening Visit through the End-of-Trial Visit. TEAEs are defined as adverse events that occurred on/after administration of the double-blind study drug and within 72 hours after the double-blind study drug administration.
Change From Baseline in Supine Bolus Flow Time (BFT)
Time frame: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Supine BFT defined as the median measurement from the 10 available swallows in supine position as measured by high resolution impedance manometry (HRIM), and determined by the central read (seconds; longer times=more severe achalasia). Change=(postdose supine BFT - predose supine BFT).
Change From Baseline in Upright BFT
Time frame: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Upright BFT defined as the median measurement from the 5 available swallows in the upright position as measured by HRIM, and determined by the central read (seconds; longer times=more severe achalasia). Change = (postdose upright BFT - predose upright BFT).
Change From Baseline in Supine Integrated Relaxation Pressure (IRP)
Time frame: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Supine IRP defined as the median measurement from the 10 available swallows in supine position as determined by the central read (mmHg; higher pressure=more severe achalasia), measured by HRIM. Change = (postdose supine IRP - predose supine IRP).
Change From Baseline in Upright IRP
Time frame: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
Upright IRP is defined as the median measurement from the 5 available swallows in the supine position as determined by the central read (mmHg; higher pressure=more severe achalasia), measured by HRIM. Change = (postdose upright IRP - predose upright IRP).
Change From Baseline in 1 Minute Impedance Bolus Height (IBH)
Time frame: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
1 minute IBH defined by the height in esophagus of 200 mL saline bolus 1 minute post-bolus as measured by HRIM and determined by the central read (cm; greater height=more severe achalasia). Change = (postdose height 1 min IBH - predose height 1 min IBH)
Change From Baseline in 2 Minute IBH
Time frame: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
2 minute IBH defined by the height in esophagus of 200 mL saline bolus 2 minutes post-bolus as measured by HRIM and determined by the central read (cm; greater height=more severe achalasia). Change = (postdose height 2 min IBH - predose height 2 min IBH).
Change From Baseline in 5 Minute IBH
Time frame: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose
5 minute IBH defined by the height in esophagus of 200 mL saline bolus 5 minutes post-bolus as determined by the central read (cm; greater height=more severe achalasia). Change = (postdose height 5 min IBH - predose height 5 min IBH).
Area Under the Plasma Concentration Time Curve From Time 0 to the Last Observation (AUClast)
Time frame: Day 1 predose: 0 (≤15 minutes); Day 1 postdose: 0.5 hours (±2 minutes), 1, 2, 3, 4, 5, 6, 8 hours (±5 minutes), 12, 17 hours (±15 minutes). Day 2 postdose 24 hours (±30 minutes). End of Treatment Visit: Day 21 (±7 days).
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 predose: 0 (≤15 minutes); Day 1 postdose: 0.5 hours (±2 minutes), 1, 2, 3, 4, 5, 6, 8 hours (±5 minutes), 12, 17 hours (±15 minutes). Day 2 postdose 24 hours (±30 minutes). End of Treatment Visit: Day 21 (±7 days).
Time of Maximum Observed Plasma Concentration (Tmax)
Time frame: Day 1 predose: 0 (≤15 minutes); Day 1 postdose: 0.5 hours (±2 minutes), 1, 2, 3, 4, 5, 6, 8 hours (±5 minutes), 12, 17 hours (±15 minutes). Day 2 postdose 24 hours (±30 minutes). End of Treatment Visit: Day 21 (±7 days).

Results and safety

Results posted to the registry on 4 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	2	2
Olinciguat	7	7

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs)

Time frame: Deaths, SAEs, and AEs: from enrollment through end-of-trial visit Day 21 (±7 days). TEAEs: from first dose of study drug through 72 hours postdose.. Count of participants. Unit: Participants

Measure	Placebo n = 2	Olinciguat n = 7
>= 1 TEAE	1	2
Deaths	0	0
>= 1 SAE	0	0
>= 1 ADO	0	0

Population analysed: All participants who received study drug were included in the Safety Population and were evaluated for according to the treatment they actually received.

Primary outcome: Change From Baseline in Supine Bolus Flow Time (BFT)

Time frame: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose. Mean (Standard Deviation). Unit: seconds

Measure	Placebo n = 1	Olinciguat n = 6
Baseline	1.240 (NA)	0.297 (0.727)
Change From Baseline	-0.570 (NA)	0.270 (0.657)

Population analysed: Pharmacodynamic (PD) Population: All participants who received study drug had at least 1 postdose PD assessment.

Primary outcome: Change From Baseline in Upright BFT

Time frame: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose. Mean (Standard Deviation). Unit: seconds

Measure	Placebo n = 1	Olinciguat n = 7
Baseline	1.160 (NA)	0.002 (0.004)
Change From Baseline	0.580 (NA)	0.143 (0.356)

Population analysed: PD Population: All participants who received study drug and had at least 1 postdose PD assessment.

Primary outcome: Change From Baseline in Supine Integrated Relaxation Pressure (IRP)

Time frame: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose. Mean (Standard Deviation). Unit: mm Hg

Measure	Placebo n = 2	Olinciguat n = 7
Baseline	17.950 (9.263)	45.214 (15.730)
Change From Baseline	3.900 (8.556)	-7.471 (7.456)

Population analysed: PD Population: All participants who received study drug and had at least 1 postdose PD assessment.

Adverse events

Time frame: Deaths and SAEs: from enrollment through end-of trial visit Day 21 (±7 days). AEs: from first dose of study drug through Day 2 (±72 hours).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Olinciguat	0 of 7 (0%)	2 of 7 (28.6%)	0 of 7

Limitations and caveats (from the sponsor): The study was prematurely terminated due to enrollment challenges after 9 participants had completed the study. The small number of participants limits the interpretation of study results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Achalasia

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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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olinciguat in people with Achalasia, run by Cyclerion Therapeutics at 5 sites in United States.

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 2 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: stopped early, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2021). 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 Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs) (time frame: Deaths, SAEs, and AEs: from enrollment through end-of-trial visit Day 21 (±7 days). TEAEs: from first dose of study drug through 72 hours postdose.). The study lists 11 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 NCT02931565.

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 4 May 2021.