Trial · NCT02931565
Study of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Type I or II Achalasia
NCT02931565, Phase 2, Terminated, Cyclerion Therapeutics; results first posted 2021-05-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Type I or II Achalasia. Trials, record NCT02931565. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02931565
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Type I or II Achalasia
- NCT number
- NCT02931565
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Cyclerion Therapeutics
- Conditions
- Achalasia
- Interventions
- Olinciguat, Matching Placebo
- First posted
- 2016-10-13
- Last updated
- 2021-05-04
- Results first posted
- 2021-05-04
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs) | 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. |
| Primary | Change From Baseline in Supine Bolus Flow Time (BFT) | 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). |
| Primary | Change From Baseline in Upright BFT | 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). |
| Primary | Change From Baseline in Supine Integrated Relaxation Pressure (IRP) | 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). |
| Primary | Change From Baseline in Upright IRP | 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). |
| Primary | Change From Baseline in 1 Minute Impedance Bolus Height (IBH) | 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) |
| Primary | Change From Baseline in 2 Minute IBH | 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). |
| Primary | Change From Baseline in 5 Minute IBH | 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). |
| Primary | Area Under the Plasma Concentration Time Curve From Time 0 to the Last Observation (AUClast) | 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). | |
| Primary | Maximum Observed Plasma Concentration (Cmax) | 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). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs) | 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. | All participants who received study drug were included in the Safety Population and were evaluated for according to the treatment they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Supine Bolus Flow Time (BFT) | Day 1: predose (baseline) and 3 hours (+15 minutes) postdose | Pharmacodynamic (PD) Population: All participants who received study drug had at least 1 postdose PD assessment. | seconds | MEAN |
| PRIMARY | Change From Baseline in Upright BFT | Day 1: predose (baseline) and 3 hours (+15 minutes) postdose | PD Population: All participants who received study drug and had at least 1 postdose PD assessment. | seconds | MEAN |
| PRIMARY | Change From Baseline in Supine Integrated Relaxation Pressure (IRP) | Day 1: predose (baseline) and 3 hours (+15 minutes) postdose | PD Population: All participants who received study drug and had at least 1 postdose PD assessment. | mm Hg | MEAN |
| PRIMARY | Change From Baseline in Upright IRP | Day 1: predose (baseline) and 3 hours (+15 minutes) postdose | PD Population: All participants who received study drug and had at least 1 postdose PD assessment. | mm Hg | MEAN |
| PRIMARY | Change From Baseline in 1 Minute Impedance Bolus Height (IBH) | Day 1: predose (baseline) and 3 hours (+15 minutes) postdose | PD Population: All participants who received study drug and had at least 1 postdose PD assessment. | cm | MEAN |
| PRIMARY | Change From Baseline in 2 Minute IBH | Day 1: predose (baseline) and 3 hours (+15 minutes) postdose | PD Population: All participants who received study drug and had at least 1 postdose PD assessment. | cm | MEAN |
| PRIMARY | Change From Baseline in 5 Minute IBH | Day 1: predose (baseline) and 3 hours (+15 minutes) postdose | PD Population: All participants who received study drug and had at least 1 postdose PD assessment. | cm | MEAN |
| PRIMARY | Area Under the Plasma Concentration Time Curve From Time 0 to the Last Observation (AUClast) | 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). | Pharmacokinetic (PK) Population: All participants who received olinciguat and had at least 1 evaluable postdose PK parameter assessment. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) | 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). | PK Population: All participants who received olinciguat and had at least 1 evaluable postdose PK parameter assessment. | ng/mL | GEOMETRIC_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs) | Placebo | >= 1 TEAE | 1 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs) | Olinciguat | >= 1 TEAE | 2 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs) | Placebo | Deaths | 0 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs) | Olinciguat | Deaths | 0 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs) | Placebo | >= 1 SAE | 0 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs) | Olinciguat | >= 1 SAE | 0 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs) | Placebo | >= 1 ADO | 0 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs) | Olinciguat | >= 1 ADO | 0 | Participants | |
| Change From Baseline in Supine Bolus Flow Time (BFT) | Placebo | Baseline | 1.240 | Standard Deviation NA | seconds |
| Change From Baseline in Supine Bolus Flow Time (BFT) | Olinciguat | Baseline | 0.297 | Standard Deviation 0.727 | seconds |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 2 | |
| Overall Study | STARTED | Olinciguat | 7 | |
| Overall Study | COMPLETED | Placebo | 2 | |
| Overall Study | COMPLETED | Olinciguat | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Olinciguat | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Presyncope | Nervous system disorders | Placebo | 0 | 2 | |
| other | Presyncope | Nervous system disorders | Olinciguat | 1 | 7 | |
| other | Dizziness | Nervous system disorders | Placebo | 1 | 2 | |
| other | Dizziness | Nervous system disorders | Olinciguat | 0 | 7 | |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 2 | |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Olinciguat | 1 | 7 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 2 |
| Total, all-cause mortality | Olinciguat | 0 | 7 |
| Total, other adverse events | Placebo | 1 | 2 |
| Total, other adverse events | Olinciguat | 2 | 7 |
| Total, serious adverse events | Placebo | 0 | 2 |
| Total, serious adverse events | Olinciguat | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Olinciguat vs Placebo: deaths from any cause | Trial comparisons |
| Olinciguat vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02931565
GET https://conductscience.org/api/trials/v1/NCT02931565/results?page=2