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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005431-70 | EudraCT Number | ||
| 2024-511925-71-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paltusotine | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paltusotine | Drug | Paltusotine, tablets, once daily by mouth |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 36 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 36 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crinetics Study Site | Los Angeles | California | 90048 | United States | ||
| Crinetics Study Site |
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Participants were randomized to treatment or placebo in a 1:1 ratio. Participants who completed the RC phase or who met rescue criteria could enter the open-label extension (OLE) phase. The RC Phase is completed. The OLE Phase is ongoing.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paltusotine | Participants were randomized in a 1:1 ratio and received a daily dose paltusotine orally. |
| FG001 | Placebo | Participants were randomized to receive matching placebo tablets in a 1:1 ratio. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| RC Phase (Up to Week 36) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2024 | Oct 20, 2025 |
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| Placebo | Drug | Placebo, tablets, once daily by mouth |
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| 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. | 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. | Baseline to 36 Weeks |
| Torrance |
| California |
| 90502 |
| United States |
| Crinetics Study Site | Baltimore | Maryland | 21205 | United States |
| Crinetics Study Site | Boston | Massachusetts | 02114 | United States |
| Crinetics Study Site | Philadelphia | Pennsylvania | 19104 | United States |
| Crinetics Study Site | Pittsburgh | Pennsylvania | 15212 | United States |
| Crinetics Study Site | Nashville | Tennessee | 37203 | United States |
| Crinetics Study Site | CABA | Buenos Aires | C1012AAR | Argentina |
| Crinetics Study Site | Ciudad Autonoma de Buenos Aire | Buenos Aires | C1405BCH | Argentina |
| Crinetics Study Site | Córdoba | X5000 | Argentina |
| Crinetics Study Site | Ghent | 9000 | Belgium |
| Crinetics Study Site | Fortaleza | Ceará | 60430-275 | Brazil |
| Crinetics Study Site | Curitiba | Paraná | 80030-110 | Brazil |
| Crinetics Study Site | Porto Alegre | Rio Grande do Sul | 90410-000 | Brazil |
| Crinetics Study Site | Rio de Janeiro | 20231-092 | Brazil |
| Crinetics Study Site | Rio de Janeiro | 21941-913 | Brazil |
| Crinetics Study Site | Sofia | 1431 | Bulgaria |
| Crinetics Study Site | Bron | 69677 | France |
| Crinetics Study Site | Pessac | 33604 | France |
| Crinetics Study Site | Budapest | 1083 | Hungary |
| Crinetics Study Site | Pécs | 7624 | Hungary |
| Crinetics Study Site | Beersheba | 8410101 | Israel |
| Crinetics Study Site | Petah Tikva | 4941480 | Israel |
| Crinetics Study Site | Roma | 00168 | Italy |
| Crinetics Study Site | San Isidro | Lima region | 15023 | Peru |
| Crinetics Study Site | Bydgoszcz | 85-605 | Poland |
| Crinetics Study Site | Poznan | 60-355 | Poland |
| Crinetics Study Site | Kemerovo | Kemerovo Oblast | 650066 | Russia |
| Crinetics Study Site | Novosibirsk | Novosibirsk Oblast | 630005 | Russia |
| Crinetics Study Site | Novosibirsk | Novosibirsk Oblast | 630087 | Russia |
| Crinetics Study Site | Samara | Samara Oblast | 443041 | Russia |
| Crinetics Study Site | Kazan' | Tatarstan Republic | 420097 | Russia |
| Crinetics Study Site | Moscow | 117186 | Russia |
| Crinetics Study Site | Moscow | 119435 | Russia |
| Crinetics Study Site | Moscow | 125008 | Russia |
| Crinetics Study Site | Belgrade | 11000 | Serbia |
| Crinetics Study Site | Sheffield | South Yorkshire | S102JF | United Kingdom |
| Crinetics Study Site | Coventry | West Midlands | CV2 2DX | United Kingdom |
| Crinetics Study Site | London | W12 0HS | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| OLE Phase (Up to Week 240) |
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The Full Analysis Set (FAS) was defined from the intention-to-treat principle and included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Paltusotine | Participants were randomized in a 1:1 ratio and received a daily dose paltusotine orally. |
| BG001 | Placebo | Participants were randomized to receive matching placebo tablets in a 1:1 ratio. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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). | Full Analysis Set | Posted | Number | percentage of participants | 36 Weeks |
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| Secondary | 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). | Full Analysis Set | Posted | Least Squares Mean | Standard Error | nanograms per milliliter (ng/ml) | Baseline to 36 Weeks |
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| Secondary | 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. | Full Analysis Set. Only those participants with data available at specified timepoints have been presented. | Posted | Number | percentage of participants | Week 34 |
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| Secondary | 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. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 36 Weeks |
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Up to 36 Weeks
Serious TEAEs and TEAEs were collected in a safety analysis set which was comprised of all participants who received study drug with treatment assignment based on the treatment received. The adverse events are presented as of last participant visit in the RC phase only. Final adverse events from the ongoing OLE will be reported after study completion. All participants, irrespective of their dose level in the paltusotine or placebo arms, have been presented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paltusotine | Participants were randomized in a 1:1 ratio and received a daily dose of paltusotine orally. | 0 | 30 | 0 | 30 | 24 | 30 |
| EG001 | Placebo | Participants were randomized to receive matching placebo tablets in a 1:1 ratio. | 0 | 28 | 1 | 28 | 28 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cholecystitis acute | Hepatobiliary disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Hyperhidrosis | General disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Director | Crinetics Pharmaceuticals, Inc. | (833) 276-4636 | medinfo@crinetics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2023 | Oct 21, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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