A Phase 3 interventional study of Paltusotine and Placebo in Acromegaly, sponsored by Crinetics Pharmaceuticals Inc.. Terminated at 39 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Crinetics Pharmaceuticals Inc. (part of Vertex Pharmaceuticals Incorporated) · Phase 3, Interventional, and Treatment
A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.
202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.
This study's enrollment of 58 is above the median of 43 across 115 interventional studies indexed under Acromegaly.
Browse Acromegaly studies →Crinetics Pharmaceuticals Inc. is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 6 (50%) have results posted.
First submitted before Crinetics Pharmaceuticals Inc. became part of Vertex Pharmaceuticals Incorporated.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Paltusotine
Drug: Placebo
Paltusotine, tablets, once daily by mouth
Also known as: CRN00808
Placebo, tablets, once daily by mouth
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)
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).
Time frame: 36 Weeks
Change From Baseline in IGF-1 to EOR
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).
Time frame: Baseline to 36 Weeks
Percentage of Participants With GH <1.0 ng/mL at 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.
Time frame: Week 34
Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOR
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.
Time frame: Baseline to 36 Weeks
This is a Phase 3, multicenter, randomized, placebo-controlled study where a total of 115 participants were screened, of which 58 participants were randomized (30 participants in the total paltusotine group and 28 participants in the placebo group) to the randomized control (RC) Phase.
| Milestone | Paltusotine | Placebo |
|---|---|---|
| Started | 30 | 28 |
| Completed | 30 | 27 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Milestone | Paltusotine | Placebo |
|---|---|---|
| Started | 27 | 26 |
| Ongoing | 27 | 26 |
| Completed | 0 | 0 |
| Not completed | 27 | 26 |
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).
| percentage of participants | Paltusotine | Placebo |
|---|---|---|
| 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) | 83.3 | 3.6 |
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).
| nanograms per milliliter (ng/ml) | Paltusotine | Placebo |
|---|---|---|
| Change From Baseline in IGF-1 to EOR | 0.042 ± 0.0932 | 0.833 ± 0.0962 |
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.
| percentage of participants | Paltusotine | Placebo |
|---|---|---|
| Percentage of Participants With GH <1.0 ng/mL at Week 34 | 87.0 | 27.8 |
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.
| units on a scale | Paltusotine | Placebo |
|---|---|---|
| Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOR | -0.606 ± 1.5044 | 4.558 ± 1.5926 |
Collected over Up to 36 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paltusotine | 0/30 (0%) | 0/30 (0%) | 24/30 (80%) |
| Placebo | 0/28 (0%) | 1/28 (3.6%) | 28/28 (100%) |
| Event | Paltusotine | Placebo |
|---|---|---|
| cholecystitis acuteHepatobiliary disorders | 0/30 | 1/28 |
| Event | Paltusotine | Placebo |
|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 9/30 | 16/28 |
| Peripheral swellingGeneral disorders | 2/30 | 10/28 |
| HeadacheNervous system disorders | 6/30 | 10/28 |
| ParaesthesiaNervous system disorders | 0/30 | 7/28 |
| DiarrhoeaGastrointestinal disorders | 7/30 | 4/28 |
| COVID-19Infections and infestations | 0/30 | 6/28 |
| FatigueGeneral disorders | 2/30 | 5/28 |
| Abdominal painGastrointestinal disorders | 5/30 | 3/28 |
| ConstipationGastrointestinal disorders | 2/30 | 4/28 |
| AstheniaGeneral disorders | 1/30 | 4/28 |
The Full Analysis Set (FAS) was defined from the intention-to-treat principle and included all randomized participants.
| Age, Continuous(years) | Paltusotine | Placebo | Total |
|---|---|---|---|
| Mean | 55.9 ± 14.57 | 53.9 ± 12.89 | 54.9 ± 13.70 |
| Sex: Female, Male(Participants) | Paltusotine | Placebo | Total |
|---|---|---|---|
| Female | 15 | 17 | 32 |
| Male | 15 | 11 | 26 |
| Ethnicity (NIH/OMB)(Participants) | Paltusotine | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 8 | 19 |
| Not Hispanic or Latino | 17 | 18 | 35 |
| Unknown or Not Reported | 2 | 2 | 4 |
| Race (NIH/OMB)(Participants) | Paltusotine | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 23 | 19 | 42 |
| More than one race | 3 | 4 | 7 |
| Unknown or Not Reported | 2 | 2 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2021 to primary completion in Jul 2023, 25 months.
Results were first posted in Jan 2026, 2 years 6 months after primary completion. A results delay was requested in Jul 2024.
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This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Paltusotine
Crinetics Pharmaceuticals Inc. →