Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-31 @ 4:18 AM
Study NCT ID:
NCT05361668
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-31
First Post:
2022-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020230', 'term': 'Serotonin Syndrome'}, {'id': 'D002276', 'term': 'Carcinoid Tumor'}, {'id': 'C562842', 'term': 'Carcinoid Tumors, Intestinal'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}], 'ancestors': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011897', 'term': 'Random Allocation'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@crinetics.com', 'phone': '(858) 450-6464', 'title': 'Study Director', 'organization': 'Crinetics Pharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected over the 8 weeks of the RTP phase, and an EOS Visit was to occur to collect the safety data and other assessments, 28 days after last dose of study drug and was required for subjects who completed the study or early terminated. TEAE data were summarized from first dose date until last dose date (end of RTP or early term) plus 28 days (Safety follow up).', 'description': 'AE results were reported based on the dose assigned at randomization (40 mg and 80 mg paltusotine), regardless of the actual dose received at the time of AE reporting. Dose changes at Weeks 2 or 4 were allowed for symptom control (increase) or poor tolerability (decrease).', 'eventGroups': [{'id': 'EG000', 'title': '40 mg Paltusotine', 'description': 'Randomized: 40 mg paltusotine: Two 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 80 mg)', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 16, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': '80 mg Paltusotine', 'description': 'Randomized: 80 mg paltusotine: Four 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg)', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 15, 'seriousNumAtRisk': 18, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Large intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety - Incidence of Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '40 mg Paltusotine', 'description': 'Randomized: 40 mg paltusotine: Two 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 80 mg)'}, {'id': 'OG001', 'title': '80 mg Paltusotine', 'description': 'Randomized: 80 mg paltusotine: Four 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg)'}], 'classes': [{'title': 'Treatment-Emergent Adverse Events (TEAE)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'TEAE Related to CS Symptoms', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Highest Severity of TEAE: Severe TEAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Highest Severity of TEAE: Moderate TEAE', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Highest Severity of TEAE: Mild TEAE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Serious TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Related TEAE', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Related Serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TEAE Leading to Study Discontinuation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'TEAE Leading to Actions Taken with Study Treatment: Dose Increased', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'TEAE Leading to Actions Taken with Study Treatment: Dose Decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Actions Taken with Study Treatment: Drug Withdrawn', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Actions Taken with Study Treatment: Drug Interrupted', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Actions Taken with Study Treatment: Dose Not Changed', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Actions Taken with Study Treatment: Not Applicable', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of investigational medicine to End of Randomized Treatment Phase (8 weeks)', 'description': 'Incidence of TEAEs, including serious TEAEs and TEAEs leading to discontinuation; change from baseline to the EOR in safety parameters: clinical laboratory tests, physical exam findings, vital signs, 12-lead ECG, and 24-hour continuous cardiac monitoring (only for subjects on 120 mg dose). In addition to all-cause mortality, deaths were categorized by primary cause (e.g., cardiovascular) based on medical adjudication. Events were coded using MedDRA and summarized by treatment group, system organ class, and preferred term.\n\nTEAEs were reported per randomized arm. There were 2 randomized arms (40 mg and 80 mg paltusotine, with up-or down-dose titration permitted for symptom control). Results are analyzed based on the initially assigned randomization arm, regardless of the actual dose received.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all randomized participants receiving ≥1 dose. TEAEs (reported per randomized arm) are defined as AEs from first to last dose date (end of RTP, or early term), plus 28 days (Safety follow up). Dose changes at Weeks 2 or 4 were allowed for symptom control (increase) or poor tolerability (decrease). Results are provided by randomized arms (40 mg and 80 mg paltusotine).'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK) of Paltusotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '40 mg Paltusotine', 'description': '40 mg paltusotine: Two 20 mg tablets QD'}, {'id': 'OG001', 'title': '80 mg Paltusotine', 'description': '80 mg paltusotine: Four 20 mg tablets QD'}, {'id': 'OG002', 'title': '120 mg Paltusotine', 'description': '120 mg paltusotine: Six 20 mg tablets QD'}], 'classes': [{'title': 'WEEK 1 (POST-DOSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '188', 'spread': '80.8', 'groupId': 'OG000'}, {'value': '360', 'spread': '103.3', 'groupId': 'OG001'}]}]}, {'title': 'WEEK 2 (PRE-DOSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '61.4', 'spread': '153.5', 'groupId': 'OG000'}, {'value': '193', 'spread': '83.5', 'groupId': 'OG001'}]}]}, {'title': 'WEEK 2 (POST-DOSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '217', 'spread': '90.5', 'groupId': 'OG000'}, {'value': '473', 'spread': '78.7', 'groupId': 'OG001'}, {'value': '1240', 'spread': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'WEEK 4 (PRE-DOSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '68.2', 'spread': '179.1', 'groupId': 'OG000'}, {'value': '158', 'spread': '74.7', 'groupId': 'OG001'}, {'value': '218', 'spread': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'WEEK 4 (POST-DOSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '209', 'spread': '202.1', 'groupId': 'OG000'}, {'value': '462', 'spread': '82.7', 'groupId': 'OG001'}, {'value': '545', 'spread': '184.5', 'groupId': 'OG002'}]}]}, {'title': 'WEEK 6 (PRE-DOSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '57.8', 'spread': '188.8', 'groupId': 'OG000'}, {'value': '155', 'spread': '63.1', 'groupId': 'OG001'}, {'value': '146', 'spread': '58.4', 'groupId': 'OG002'}]}]}, {'title': 'WEEK 6 (POST-DOSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '261', 'spread': '108.6', 'groupId': 'OG000'}, {'value': '532', 'spread': '89.4', 'groupId': 'OG001'}, {'value': '474', 'spread': '79.0', 'groupId': 'OG002'}]}]}, {'title': 'WEEK 8 - EOR (PRE-DOSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '63.3', 'spread': '122.1', 'groupId': 'OG000'}, {'value': '165', 'spread': '44.5', 'groupId': 'OG001'}, {'value': '201', 'spread': '69.1', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured at each visit (pre and post dose) up to Week 8 (i.e., End of Randomized Treatment Phase [EOR])', 'description': 'Steady state trough levels by dose and visit for Randomized Treatment Phase (RTP).\n\nThe "Overall Number of Participants Analyzed" displayed at the top of the PK summary table represents the total number of participants who received each dose at any point during the trial, factoring in dose titrations. PK results are summarized by actual dose taken right before the time of sample collection, rather than by randomized dose. Participants may be included in different dose groups for different visits due to dose titration.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis Set included all randomized participants with ≥1 paltusotine dose and ≥1 plasma measurement. Post-dose samples were taken 1-3 hrs after dosing, and steady-state troughs were assessed pre and post dose, through Week 8. Primary PK summaries were based on the RTP. Dose adjustments at Weeks 2 or 4 were allowed for symptom control (dose increase) or tolerability (dose decrease).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '40 mg Paltusotine', 'description': 'Randomized: 40 mg paltusotine: Two 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 80 mg)'}, {'id': 'FG001', 'title': '80 mg Paltusotine', 'description': 'Randomized: 80 mg paltusotine: Four 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'comment': 'Dose adjustments could be made once at Week 2 or Week 4 if carcinoid syndrome symptoms met the criteria for short-acting octreotide rescue (dose increase), or if there was unacceptable tolerability of the randomized dose (dose decrease).', 'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Adverse Event', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed\\_RTP', 'groupId': 'FG000', 'numSubjects': '17'}, {'comment': 'Completed\\_RTP', 'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'In general, results are reported based on the dose assigned at randomization, regardless of the actual dose received.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '40 mg Paltusotine', 'description': 'Randomized: 40 mg paltusotine: Two 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 80 mg)'}, {'id': 'BG001', 'title': '80 mg Paltusotine', 'description': 'Randomized: 80 mg paltusotine: Four 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.6', 'groupId': 'BG000', 'lowerLimit': '35', 'upperLimit': '83'}, {'value': '62.9', 'groupId': 'BG001', 'lowerLimit': '41', 'upperLimit': '78'}, {'value': '60.8', 'groupId': 'BG002', 'lowerLimit': '35', 'upperLimit': '83'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Europe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'South America', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.057', 'spread': '4.3181', 'groupId': 'BG000'}, {'value': '28.609', 'spread': '10.8261', 'groupId': 'BG001'}, {'value': '28.833', 'spread': '17.58', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Symptomatic Entry Criteria Met - n (%)', 'classes': [{'categories': [{'title': 'Bowel Movement Criteria Only', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Flushing Criteria Only', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Bowel Movement and Flushing Criteria', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Mean Daily Bowel Movements (/day)', 'classes': [{'categories': [{'measurements': [{'value': '3.881', 'spread': '2.0398', 'groupId': 'BG000'}, {'value': '3.343', 'spread': '1.3705', 'groupId': 'BG001'}, {'value': '3.612', 'spread': '1.7343', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'BMs per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Mean Daily Flushing Criteria Episode (/day)', 'classes': [{'categories': [{'measurements': [{'value': '2.325', 'spread': '1.3219', 'groupId': 'BG000'}, {'value': '2.413', 'spread': '2.3313', 'groupId': 'BG001'}, {'value': '2.369', 'spread': '1.8683', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'FE per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration Since Carcinoid Syndrome Diagnosis (Months)', 'classes': [{'categories': [{'measurements': [{'value': '102.566', 'spread': '82.0788', 'groupId': 'BG000'}, {'value': '54.459', 'spread': '37.1727', 'groupId': 'BG001'}, {'value': '78.513', 'spread': '67.3684', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Screening Group, n (%)', 'classes': [{'categories': [{'title': 'Not Currently on SRLs or Naïve to SRLs', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Currently Treated with Lanreotide, Octreotide LAR, or Short-acting Octreotide', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tumor Confirmation Method, n (%)', 'classes': [{'categories': [{'title': 'MRI', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'CT Scan', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-01-21', 'size': 2469236, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-05T03:08', 'hasProtocol': True}, {'date': '2024-01-19', 'size': 865328, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-08T00:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-03', 'studyFirstSubmitDate': '2022-04-27', 'resultsFirstSubmitDate': '2025-07-10', 'studyFirstSubmitQcDate': '2022-05-02', 'lastUpdatePostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-03', 'studyFirstPostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety - Incidence of Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'First dose of investigational medicine to End of Randomized Treatment Phase (8 weeks)', 'description': 'Incidence of TEAEs, including serious TEAEs and TEAEs leading to discontinuation; change from baseline to the EOR in safety parameters: clinical laboratory tests, physical exam findings, vital signs, 12-lead ECG, and 24-hour continuous cardiac monitoring (only for subjects on 120 mg dose). In addition to all-cause mortality, deaths were categorized by primary cause (e.g., cardiovascular) based on medical adjudication. Events were coded using MedDRA and summarized by treatment group, system organ class, and preferred term.\n\nTEAEs were reported per randomized arm. There were 2 randomized arms (40 mg and 80 mg paltusotine, with up-or down-dose titration permitted for symptom control). Results are analyzed based on the initially assigned randomization arm, regardless of the actual dose received.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK) of Paltusotine', 'timeFrame': 'Measured at each visit (pre and post dose) up to Week 8 (i.e., End of Randomized Treatment Phase [EOR])', 'description': 'Steady state trough levels by dose and visit for Randomized Treatment Phase (RTP).\n\nThe "Overall Number of Participants Analyzed" displayed at the top of the PK summary table represents the total number of participants who received each dose at any point during the trial, factoring in dose titrations. PK results are summarized by actual dose taken right before the time of sample collection, rather than by randomized dose. Participants may be included in different dose groups for different visits due to dose titration.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuroendocrine tumor', 'Paltusotine', 'CRN00808', 'Carcinoid syndrome', 'Lanreotide', 'Octreotide', 'Somatostatin agonist'], 'conditions': ['Carcinoid Syndrome', 'Carcinoid', 'Carcinoid Tumor', 'Carcinoid Tumor of Ileum', 'Carcinoid Tumor of Cecum', 'Carcinoid Syndrome Diarrhea', 'Carcinoid Intestine Tumor', 'Carcinoid Tumor of Liver', 'Carcinoid Tumor of Pancreas']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) Phase.', 'detailedDescription': 'This is a Phase 2, randomized, open-label, parallel-group, multicenter study designed to evaluate the safety, pharmacokinetics, and efficacy of paltusotine treatment in subjects with carcinoid syndrome. The study was conducted in 2 parts: a Randomized Treatment Phase (RTP) which is completed, and an Open-label Extension (OLE) Phase which is still ongoing. The RTP consisted of paltusotine treatment for 8 weeks. Subjects who completed the RTP were eligible to enter the OLE Phase at the recommendation of the Investigator. In the ongoing OLE Phase, paltusotine is being administered for a further 102 weeks. The total duration of paltusotine treatment for the combined RTP and OLE Phase is up to 110 weeks (28 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Male or female subjects ≥18 years of age. 2. Documented carcinoid syndrome requiring medical therapy.\n\n1. Not currently treated with somatostatin receptor ligands agonists for at least 12 weeks prior to screening and actively symptomatic. This can include treatment-naïve subjects.\n2. Subjects currently treated with lanreotide, octreotide long acting release, or short acting octreotide (subcutaneous or oral) who are currently symptomatically controlled\n3. Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor (NET). Tumors must be Grade 1 (Ki-67 index \\< 3%, or a mitotic count of \\< 2 mitoses per 10 high-power fields, if the Ki-67 index is not available) or Grade 2 (Ki-67 index 3-20%, or a mitotic count of 2-20 mitoses per 10 high-power fields, if the Ki-67 index is not available) per the World Health Organization neuroendocrine neoplasm classification (Rindi and Inzani, 2020). Grade 3 tumors are not eligible.\n4. No significant disease progression as assessed by the Investigator within the last 6 months before initiation of study drug dosing.\n\nExclusion Criteria:\n\n1. Diarrhea attributed to any condition(s) other than carcinoid syndrome.\n2. Uncontrolled/severe diarrhea associated with significant volume contraction, dehydration, or hypotension.\n3. Requires second line treatments (eg, telotristat) for control of carcinoid syndrome symptoms.\n4. Treatment with specific NET tumor therapy \\<4 weeks before Screening (such as everolimus or sunitinib) or hepatic embolization, radiotherapy, peptide receptor radionuclide therapy (PRRT), and/or tumor debulking \\<12 weeks before Screening.\n5. History of another primary malignancy \\<3 years prior to the date of first dose, except for adequately treated basal or squamous cell carcinoma of the skin, cancer of the breast or cervix in situ, previously treated or concurrent malignancy determined to be clinically stable and not requiring treatment.\n6. Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry.'}, 'identificationModule': {'nctId': 'NCT05361668', 'briefTitle': 'Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Crinetics Pharmaceuticals Inc.'}, 'officialTitle': 'A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects With Carcinoid Syndrome', 'orgStudyIdInfo': {'id': 'CRN00808-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '40 mg Paltusotine', 'description': 'Participants received paltusotine 40mg, in tablet form, orally, daily, for 8 weeks.', 'interventionNames': ['Drug: Randomized: 40 mg Paltusotine']}, {'type': 'EXPERIMENTAL', 'label': '80 mg Paltusotine', 'description': 'Participants received paltusotine 80mg, in tablet form, orally, daily for 8 weeks.', 'interventionNames': ['Drug: Randomized: 80 mg Paltusotine']}], 'interventions': [{'name': 'Randomized: 40 mg Paltusotine', 'type': 'DRUG', 'description': 'Two 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 80 mg)', 'armGroupLabels': ['40 mg Paltusotine']}, {'name': 'Randomized: 80 mg Paltusotine', 'type': 'DRUG', 'description': 'Four 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg)', 'armGroupLabels': ['80 mg Paltusotine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40506', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'C1180 AAX', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Crinetics Study Site'}, {'zip': 'C1264AAA', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Crinetics Study Site'}, {'zip': 'C1426ANZ', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Crinetics Study Site'}, {'zip': 'C1017AAS', 'city': 'CABA', 'country': 'Argentina', 'facility': 'Crinetics Study Site'}, {'zip': 'C1425BGH', 'city': 'CABA', 'country': 'Argentina', 'facility': 'Crinetics Study Site'}, {'zip': '60430-275', 'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '20231-092', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '22281-100', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '88811508', 'city': 'Criciúma', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': -28.6775, 'lon': -49.36972}}, {'zip': '01509-010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '22061-080', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '06100', 'city': 'Mexico City', 'state': 'Cuauhtemoc', 'country': 'Mexico', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '76000', 'city': 'Querétaro City', 'state': 'Querétaro', 'country': 'Mexico', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 20.58806, 'lon': -100.38806}}, {'zip': '76070', 'city': 'Querétaro City', 'state': 'Querétaro', 'country': 'Mexico', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 20.58806, 'lon': -100.38806}}, {'zip': '15036', 'city': 'Lima', 'country': 'Peru', 'facility': 'Crinetics Study Site Peru #1', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '15036', 'city': 'Lima', 'country': 'Peru', 'facility': 'Crinetics Study Site Peru #2', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '40-514', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '02-351', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '53-413', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Crinetics Study Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Crinetics Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}