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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002230-20 | EudraCT Number |
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An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paltusotine | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paltusotine | Drug | Paltusotine, capsules, once daily by mouth |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level | Change from baseline in IGF-1 level at Week 13/End of Treatment (W13/EoT) in Group 1 subjects Efficacy Analysis Set (EAS). | 13 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Their Last IGF-1 Measurement ≤ Upper Limit of Normal (ULN) | The secondary endpoint was the proportion of participants who maintained IGF-1 response, defined as the last assessment before the EoT with IGF-1 ≤1.0× ULN meet responder criteria, in Group 3, 4, and 5 subjects only at W13/EoT | 13 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Gonda Diabetes Center | Los Angeles | California | 90095 | United States | ||
| Northwestern University Feinberg School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36792844 | Derived | Martin S, Bender RH, Krasner A, Marmon T, Monahan M, Nelson L. Development and evaluation of the Acromegaly Symptom Diary. J Patient Rep Outcomes. 2023 Feb 15;7(1):15. doi: 10.1186/s41687-023-00541-7. |
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A total of 45 subjects were planned to be enrolled in the study. 47 subjects participated in the study.
A total of 45 subjects were planned to be enrolled in the study. 47 subjects participated in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Partial responders on a stable treatment of octreotide long-acting release (LAR) or lanreotide depot (at least 1 Screening IGF-1 value was > upper limit of normal (ULN), and the V2 value was ≤2.5× ULN) |
| FG001 | Group 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Screening Period: up to 6 Weeks |
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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 | Jun 7, 2019 | Aug 22, 2024 |
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| Proportion of Subjects With Their Last IGF-1 Measurements ≤1.5×ULN |
Proportion of participants with IGF-1 ≤1.5× ULN at W13/EoT. |
| 13 Weeks |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48106 | United States |
| OHSU Northwest Pituitary Center | Portland | Oregon | 97239 | United States |
| Allegheny Endocrinology Associates | Pittsburgh | Pennsylvania | 15212 | United States |
| CETI - Centro de Estudos em Terapias Inovadoras | Curitiba | Brazil |
| Hospital Universitário Clementino Fraga Filho (HUCFF/UFRJ) Centro de Pesquisa em Neuroendocrinologia | Rio de Janeiro | Brazil |
| CPQuali Pesquisa Clinica | São Paulo | Brazil |
| LMU Clinic of University of Munich | Munich | Germany |
| General Hospital of Athens "Evangelismos" | Athens | Greece |
| General Hospital of Athens "Gennimatas" | Athens | Greece |
| General Hospital of Athens "Laiko" | Athens | Greece |
| General Hospital of Athens "Ippokratio" | Thessaloniki | Greece |
| Military Health Center, Division of Endocrinology | Budapest | Hungary |
| Semmelweis University Faculty of Medicine | Budapest | Hungary |
| University of Pécs Medical School | Pécs | Hungary |
| Azienda Ospedaliera Universitaria Federico II | Naples | Italy |
| Waitemata District Health Board, North Shore Hospital | Takapuna | New Zealand |
| Endocrine, Diabetes and Research Centre, Wellington Hospital | Wellington | New Zealand |
| Clinic of Endocrinology Independent Public Health Care Centre University Hospital in Kracow | Krakow | Poland |
| National Institute of Endocrinology "C. I. Parhon" | Bucharest | Romania |
| Clinical Centre Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases | Belgrade | Serbia |
| University Hospital Bratislava | Bratislava | Slovakia |
| University Hospitals Coventry and Warwickshire NHS Trust | Coventry | United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | LS9 7TF | United Kingdom |
Partial responders on a stable combination treatment of SRL (ie, octreotide LAR or lanreotide depot) and a dopamine agonist (bromocriptine or cabergoline) (at least 1 Screening IGF-1 value was >ULN, and the V2 value was ≤2.5 × ULN).
| FG002 | Group 3 | Complete responders on a stable combination treatment of SRL (ie, octreotide LAR or lanreotide depot) and a dopamine agonist (bromocriptine or cabergoline) (mean of Screening IGF-1 values were ≤ULN). |
| FG003 | Group 4 | Complete responders on a stable dose of pasireotide LAR (mean of Screening IGF-1 values were ≤ULN). |
| FG004 | Group 5 | Complete responders on a stable combination treatment of SRL (ie, octreotide LAR or lanreotide depot) and pegvisomant (mean of Screening IGF-1 values were ≤ULN). |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period: up to 13 Weeks |
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| Follow-up Period: up to 4 Weeks |
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Of the 47 participants who received CRN00808-03, 42 participants completed the trial, 4 participants withdrew from treatment period, and 1 participant withdrew consent during follow up. No participants withdrew due to adverse events.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Efficacy Analysis Set - Primary Analysis Population for all efficacy analyses. Only includes participants from Group 1. Eligibility to enter this group was specified as: Partial responders on a stable treatment of octreotide long-acting release (LAR) or lanreotide depot (at least 1 Screening IGF-1 value was greater than upper limit of normal (ULN), and the V2 value was ≤2.5× ULN) |
| BG001 | Group 2 | Eligibility to enter this group was specified as: Partial responders on a stable combination treatment of SRL (ie, octreotide LAR or lanreotide depot) and a dopamine agonist (bromocriptine or cabergoline) (at least 1 Screening IGF-1 value was >ULN, and the V2 value was ≤2.5 × ULN) |
| BG002 | Group 3 | Eligibility to enter this group was specified as: Complete responders on a stable combination treatment of SRL (ie, octreotide LAR or lanreotide depot) and a dopamine agonist (bromocriptine or cabergoline) (mean of Screening IGF-1 values were ≤ULN) |
| BG003 | Group 4 | Eligibility to enter this group was specified as: Complete responders on a stable dose of pasireotide LAR (mean of Screening IGF-1 values were ≤ULN) |
| BG004 | Group 5 | Eligibility to enter this group was specified as: Complete responders on a stable combination treatment of SRL (ie, octreotide LAR or lanreotide depot) and pegvisomant (mean of Screening IGF-1 values were ≤ULN). |
| BG005 | 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, Categorical | Count of Participants | Participants |
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| Age, Customized | (range) | Median | Full Range | 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/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | Source missing for one participant, data removed and noted as protocol deviation. | Median | Inter-Quartile Range | centimeter |
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| Weight | Source missing for one participant, data removed and noted as protocol deviation. | Median | Inter-Quartile Range | kilogram(s) |
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| BMI | Source missing for one participant, data removed and noted as protocol deviation. | Median | Inter-Quartile Range | kilogram(s)/square meter |
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| Ring Size | Finger size is an objective measure of soft tissue over-growth and is assessed using the US Ring Size Scale. Measurements are assessed on an increasing scale of US ring sizes scored from 1-17 (smallest to largest), with an increase in ring size between consecutive visits representing increased peripheral swelling. Ring sizers (Tool jewelry sizing tools) were provided to the sites, and sites were instructed to use the same hand and finger at each visit. | Source missing for one participant, data removed and noted as protocol deviation. | Median | Inter-Quartile Range | Scores on a Scale |
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| IGF-1 (x ULN) at Baseline | Median | Inter-Quartile Range | ng/mL x ULN |
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| Serum Growth Hormone Levels | Median | Inter-Quartile Range | nanogram(s)/milliliter |
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| IGFBP-3 | Median | Inter-Quartile Range | ng/mL |
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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 | Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level | Change from baseline in IGF-1 level at Week 13/End of Treatment (W13/EoT) in Group 1 subjects Efficacy Analysis Set (EAS). | Efficacy Analysis Set includes all subjects in Group 1 who received at least one dose of study drug. | Posted | Median | Inter-Quartile Range | ng/mL x ULN | 13 Weeks |
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| Secondary | Proportion of Subjects With Their Last IGF-1 Measurement ≤ Upper Limit of Normal (ULN) | The secondary endpoint was the proportion of participants who maintained IGF-1 response, defined as the last assessment before the EoT with IGF-1 ≤1.0× ULN meet responder criteria, in Group 3, 4, and 5 subjects only at W13/EoT | This endpoint was limited to only subjects in Groups 3, 4 and 5 who started the study with IGF-1 ≤ULN. | Posted | Count of Participants | Participants | 13 Weeks |
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| Secondary | Proportion of Subjects With Their Last IGF-1 Measurements ≤1.5×ULN | Proportion of participants with IGF-1 ≤1.5× ULN at W13/EoT. | This endpoint was estimated for all the subjects in the Full Analysis Set (FAS) | Posted | Count of Participants | Participants | 13 Weeks |
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| Primary | Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level | Change from baseline in IGF-1 level at Week 13/End of Treatment (W13/EoT) in Group 1 subjects Efficacy Analysis Set (EAS). | Efficacy Analysis Set includes all subjects in Group 1 who received at least one dose of study drug. | Posted | Median | Inter-Quartile Range | ng/mL x ULN | 13 Weeks |
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Participants were monitored until the end of the 4-week follow-up period (up to 17 weeks total).
Some participants received uptitrated dose during the treatment period and are therefore counted in multiple dosing groups.
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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 | Dose 5 mg | Adverse event occurred when subject was receiving 5 mg dose paltusotine | 0 | 2 | 0 | 2 | 0 | 2 |
| EG001 | Dose 10 mg | Adverse event occurred when subject was receiving 10 mg dose paltusotine | 0 | 47 | 0 | 47 | 23 | 47 |
| EG002 | Dose 20 mg | Adverse event occurred when subject was receiving 20 mg dose paltusotine | 0 | 43 | 1 | 43 | 24 | 43 |
| EG003 | Dose 30 mg | Adverse event occurred when subject was receiving 30 mg dose paltusotine | 0 | 37 | 0 | 37 | 15 | 37 |
| EG004 | Dose 40 mg | Adverse event occurred when subject was receiving 40 mg dose paltusotine | 0 | 32 | 0 | 32 | 19 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Palpitations | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Paresthesia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Peripheral swelling | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Sleep apnea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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The only disclosure restriction on the PI is that PIs cannot publish until the multi-center publication is first published. If no multi-center publication is published within 18 months of the completion date, the PI may publish their results, provided that the Sponsor is given the opportunity to review the proposed publication in advance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Crinetics Clinical Trials | Crinetics Pharmaceuticals, Inc | +1 858-450-6464 | clinicaltrials@crinetics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 1, 2020 | Aug 22, 2024 | 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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| COVID-19 Lockdown |
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Eligibility to enter this group was specified as: Complete responders on a stable combination treatment of SRL (ie, octreotide LAR or lanreotide depot) and a dopamine agonist(bromocriptine or cabergoline) (mean of Screening IGF-1 values were ≤ ULN) |
| OG004 | Group 5 | Eligibility to enter this group was specified as: Complete responders on a stable dose of pasireotide LAR (mean of Screening IGF-1 values were ≤ULN) |
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| Title | Denominators | Categories | ||||
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| Baseline |
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| Week 13 (Visit 14)/ End of Treatment |
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