Trial · NCT05192382
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)
NCT05192382, Phase 3, Terminated, Crinetics Pharmaceuticals Inc.; results first posted 2026-01-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2). Trials, record NCT05192382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05192382
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)
- NCT number
- NCT05192382
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 111 participants, actual
- Lead sponsor
- Crinetics Pharmaceuticals Inc.
- Conditions
- Acromegaly
- Interventions
- Paltusotine, Placebo
- First posted
- 2022-01-14
- Last updated
- 2026-07-15
- Other registries' IDs
- eudract:2021-001703-32
- Results first posted
- 2026-01-13
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Biochemical Response in Insulin-like Growth Factor-1 (IGF-1) at the End of the Randomized Control Phase (EOR) | Week 24 | A value \>1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Response is defined as an IGF-1 level ≤1.0×ULN based on the average of last 2 measurements. |
| Secondary | Change in IGF-1 From Baseline to EOT | Baseline to 24 weeks | A value \>1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Baseline was defined as the last non-missing assessment prior to first dose of study drug for all assessments except IGF-1, growth hormone (GH), and acromegaly symptoms diary (ASD). Change from Baseline was determined by calculating (post-Baseline value - Baseline value). |
| Secondary | Percentage of Participants Achieving IGF-1 <1.3×ULN at EOR | 24 weeks | A value \>1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Response is defined as an IGF-1 level \<1.3×ULN based on the average of last 2 measurements. |
| Secondary | Percentage of Participants With Growth Hormone (GH) Concentration <1 ng/mL at Week 22 | Week 22 | The average from integrated GH sampling at week 22 was used to determine response. |
| Secondary | Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOT | Baseline to 24 weeks | The ASD is a sponsor-developed daily diary to assess important acromegaly symptoms from the patient perspective. The weekly average ASD total score is calculated from 7 items associated with acromegaly (headache pain, joint pain, sweating, fatigue, weakness in legs, swelling, and numbness or tingling). The ASD total score ranges from 0 to 70 with each symptom contributing up to 10 points. A higher score = higher symptom severity. Change from baseline in total ASD was defined as the postbaseline total ASD score (the average of the available scores seven days on or prior to the scheduled visit date) minus the baseline total ASD score. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Biochemical Response in Insulin-like Growth Factor-1 (IGF-1) at the End of the Randomized Control Phase (EOR) | Week 24 | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Change in IGF-1 From Baseline to EOT | Baseline to 24 weeks | Full Analysis Set | nanograms per milliliter (ng/ml) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving IGF-1 <1.3×ULN at EOR | 24 weeks | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Growth Hormone (GH) Concentration <1 ng/mL at Week 22 | Week 22 | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOT | Baseline to 24 weeks | Full Analysis Set | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Biochemical Response in Insulin-like Growth Factor-1 (IGF-1) at the End of the Randomized Control Phase (EOR) | Paltusotine | 55.6 | percentage of participants | ||
| Percentage of Participants With a Biochemical Response in Insulin-like Growth Factor-1 (IGF-1) at the End of the Randomized Control Phase (EOR) | Placebo | 5.3 | percentage of participants | ||
| Change in IGF-1 From Baseline to EOT | Paltusotine | -0.819 | Standard Error 0.0789 | nanograms per milliliter (ng/ml) | |
| Change in IGF-1 From Baseline to EOT | Placebo | 0.087 | Standard Error 0.0751 | nanograms per milliliter (ng/ml) | |
| Percentage of Participants Achieving IGF-1 <1.3×ULN at EOR | Paltusotine | 66.7 | percentage of participants | ||
| Percentage of Participants Achieving IGF-1 <1.3×ULN at EOR | Placebo | 14 | percentage of participants | ||
| Percentage of Participants With Growth Hormone (GH) Concentration <1 ng/mL at Week 22 | Paltusotine | 57.4 | percentage of participants | ||
| Percentage of Participants With Growth Hormone (GH) Concentration <1 ng/mL at Week 22 | Placebo | 17.5 | percentage of participants | ||
| Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOT | Paltusotine | -2.669 | Standard Error 1.4221 | units on a scale | |
| Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOT | Placebo | 2.754 | Standard Error 1.3641 | units on a scale |
Source ClinicalTrials.gov
Participant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| RC Phase (Up to Week 24) | STARTED | RC: Paltusotine Then OLE | 54 | |
| RC Phase (Up to Week 24) | STARTED | RC: Placebo Then OLE | 57 | |
| RC Phase (Up to Week 24) | STARTED | Direct to OLE: Paltusotine | 0 | |
| RC Phase (Up to Week 24) | COMPLETED | RC: Paltusotine Then OLE | 52 | |
| RC Phase (Up to Week 24) | COMPLETED | RC: Placebo Then OLE | 54 | |
| RC Phase (Up to Week 24) | COMPLETED | Direct to OLE: Paltusotine | 0 | |
| RC Phase (Up to Week 24) | NOT COMPLETED | RC: Paltusotine Then OLE | 2 | |
| RC Phase (Up to Week 24) | NOT COMPLETED | RC: Placebo Then OLE | 3 | |
| RC Phase (Up to Week 24) | NOT COMPLETED | Direct to OLE: Paltusotine | 0 | |
| OLE Phase (Up to Week 200) | STARTED | RC: Paltusotine Then OLE | 50 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events114
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 | Diarrhoea | Gastrointestinal disorders | Paltusotine | 18 | 54 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 10 | 57 | |
| other | Diarrhoea | Gastrointestinal disorders | Direct to OLE: Paltusotine | 1 | 11 | |
| other | Dyspepsia | Gastrointestinal disorders | Paltusotine | 3 | 54 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 6 | 57 | |
| other | Dyspepsia | Gastrointestinal disorders | Direct to OLE: Paltusotine | 0 | 11 | |
| other | Abdominal pain | Gastrointestinal disorders | Paltusotine | 6 | 54 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 2 | 57 | |
| other | Abdominal pain | Gastrointestinal disorders | Direct to OLE: Paltusotine | 0 | 11 | |
| other | Nausea | Gastrointestinal disorders | Paltusotine | 5 | 54 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paltusotine | 0 | 54 |
| Total, all-cause mortality | Placebo | 0 | 57 |
| Total, all-cause mortality | Direct to OLE: Paltusotine | 0 | 11 |
| Total, other adverse events | Paltusotine | 49 | 54 |
| Total, other adverse events | Placebo | 49 | 57 |
| Total, other adverse events | Direct to OLE: Paltusotine | 6 | 11 |
| Total, serious adverse events | Paltusotine | 0 | 54 |
| Total, serious adverse events | Placebo | 1 | 57 |
| Total, serious adverse events | Direct to OLE: Paltusotine | 0 | 11 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT05192382
GET https://conductscience.org/api/trials/v1/NCT05192382/flow?page=2