Trial · NCT04837040
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly
NCT04837040, 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. Trials, record NCT04837040. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04837040
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
- NCT number
- NCT04837040
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 58 participants, actual
- Lead sponsor
- Crinetics Pharmaceuticals Inc.
- Conditions
- Acromegaly
- Interventions
- Paltusotine, Placebo
- First posted
- 2021-04-08
- Last updated
- 2026-07-15
- Other registries' IDs
- eudract:2020-005431-70
- Results first posted
- 2026-01-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Maintain Biochemical Response in IGF-1 (≤1.0× the Upper Limit of Normal [ULN]) at the End of the Randomized Control Phase (EOR) | 36 Weeks | A value \>1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Response is defined as an IGF-1 level ≤1.0×ULN based on the average of last 2 measurements (weeks 34 and 36). |
| Secondary | Change From Baseline in IGF-1 to EOR | Baseline to 36 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 With GH <1.0 ng/mL at Week 34 | Week 34 | GH maintenance of response was analyzed in participants with GH\<1.0 ng/mL at week 34, out of those who had GH\<1.0 ng/mL at Baseline, using the same methodology as the primary endpoint. |
| Secondary | Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOR | Baseline to 36 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
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Maintain Biochemical Response in IGF-1 (≤1.0× the Upper Limit of Normal [ULN]) at the End of the Randomized Control Phase (EOR) | 36 Weeks | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in IGF-1 to EOR | Baseline to 36 Weeks | Full Analysis Set | nanograms per milliliter (ng/ml) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With GH <1.0 ng/mL at Week 34 | Week 34 | Full Analysis Set. Only those participants with data available at specified timepoints have been presented. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOR | Baseline to 36 Weeks | Full Analysis Set | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Maintain Biochemical Response in IGF-1 (≤1.0× the Upper Limit of Normal [ULN]) at the End of the Randomized Control Phase (EOR) | Paltusotine | 83.3 | percentage of participants | ||
| Percentage of Participants Who Maintain Biochemical Response in IGF-1 (≤1.0× the Upper Limit of Normal [ULN]) at the End of the Randomized Control Phase (EOR) | Placebo | 3.6 | percentage of participants | ||
| Change From Baseline in IGF-1 to EOR | Paltusotine | 0.042 | Standard Error 0.0932 | nanograms per milliliter (ng/ml) | |
| Change From Baseline in IGF-1 to EOR | Placebo | 0.833 | Standard Error 0.0962 | nanograms per milliliter (ng/ml) | |
| Percentage of Participants With GH <1.0 ng/mL at Week 34 | Paltusotine | 87.0 | percentage of participants | ||
| Percentage of Participants With GH <1.0 ng/mL at Week 34 | Placebo | 27.8 | percentage of participants | ||
| Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOR | Paltusotine | -0.606 | Standard Error 1.5044 | units on a scale | |
| Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOR | Placebo | 4.558 | Standard Error 1.5926 | units on a scale |
Source ClinicalTrials.gov
Participant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| RC Phase (Up to Week 36) | STARTED | Paltusotine | 30 | |
| RC Phase (Up to Week 36) | STARTED | Placebo | 28 | |
| RC Phase (Up to Week 36) | COMPLETED | Paltusotine | 30 | |
| RC Phase (Up to Week 36) | COMPLETED | Placebo | 27 | |
| RC Phase (Up to Week 36) | NOT COMPLETED | Paltusotine | 0 | |
| RC Phase (Up to Week 36) | NOT COMPLETED | Placebo | 1 | |
| OLE Phase (Up to Week 240) | STARTED | Paltusotine | 27 | |
| OLE Phase (Up to Week 240) | STARTED | Placebo | 26 | |
| OLE Phase (Up to Week 240) | Ongoing | Paltusotine | 27 | |
| OLE Phase (Up to Week 240) | Ongoing | Placebo | 26 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events56
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 | Arthralgia | Musculoskeletal and connective tissue disorders | Paltusotine | 9 | 30 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 16 | 28 | |
| other | Muscular weakness | Musculoskeletal and connective tissue disorders | Paltusotine | 1 | 30 | |
| other | Muscular weakness | Musculoskeletal and connective tissue disorders | Placebo | 3 | 28 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Paltusotine | 1 | 30 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 2 | 28 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Paltusotine | 0 | 30 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Placebo | 3 | 28 | |
| other | Diarrhoea | Gastrointestinal disorders | Paltusotine | 7 | 30 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 4 | 28 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paltusotine | 0 | 30 |
| Total, all-cause mortality | Placebo | 0 | 28 |
| Total, other adverse events | Paltusotine | 24 | 30 |
| Total, other adverse events | Placebo | 28 | 28 |
| Total, serious adverse events | Paltusotine | 0 | 30 |
| Total, serious adverse events | Placebo | 1 | 28 |
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 |
|---|---|
| Paltusotine vs Placebo: deaths from any cause | Trial comparisons |
| Paltusotine 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/NCT04837040
GET https://conductscience.org/api/trials/v1/NCT04837040/events?page=2