NCT05051579 — consolidated Schedule of Activities

misc_studies · 1 tables · 71 activities (0% compression) · 20 columns · study-schedule-consolidated v1.0 · Layer 3
Activities:
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Common
▼ Main Schedule (20 columns)
ActivityInTable 1
Study Period
[epoch] L1		Study Period I Screening/Lead-inStudy Period I Screening/Lead-inStudy Period II Treatment Period1Study Period II Treatment Period1Study Period II Treatment Period1Study Period II Treatment Period1Study Period II Treatment Period1Study Period II Treatment Period1Study Period II Treatment Period1Study Period II Treatment Period1Study Period II Treatment Period1Study Period II Treatment Period1Study Period II Treatment Period1Study Period II Treatment Period1Study Period II Treatment Period1Study Period II Treatment Period1Study Period II Treatment Period1Study Period II Treatment Period1Study Period III Safety Follow-Up
Screening/Lead-in sub-period
[period] L2		ScreeningLead-InStudy Period II Treatment PeriodStudy Period II Treatment PeriodStudy Period II Treatment PeriodStudy Period II Treatment PeriodStudy Period II Treatment PeriodStudy Period II Treatment PeriodStudy Period II Treatment PeriodStudy Period II Treatment PeriodStudy Period II Treatment PeriodStudy Period II Treatment PeriodStudy Period II Treatment PeriodStudy Period II Treatment PeriodStudy Period II Treatment PeriodStudy Period II Treatment PeriodStudy Period II Treatment PeriodStudy Period II Treatment Period
Visit Number
[visit] L3		123456789101112131415161718ET801
Week Relative to Randomization
[week] L4		-2-101246810121316202426283236-2 Wks Post End of TXP
Allowable Interval Tolerance (days)
[window]		-±3±3±3±3±3±3±3±3±3±3±3±3±3±3±3-±3
Fasting Visit
[visit_attribute]		XXXXXXXXXXXXXXXXXXX
AdministrativeT1
Informed consentT1X
Inclusion and exclusion criteria reviewT1XX
DemographicsT1X
Preexisting conditions and medical historyT1XX
Concomitant medicationsT1XXXXXXXXXXXXXXXXXXXX
Substance use (alcohol, caffeine, tobacco use)T1X
Adverse events (AEs)T1XXXXXXXXXXXXXXXXXXXX
Physical EvaluationT1
HeightT1X
WeightT1XXXXXXXXXXXXXXXXXXX
Waist circumferenceT1XXXXXXXXXXXX
Vital signs (2 sitting BP and PR measurements)2T1XXXXXXXXXXXXXXXXXXXX
Physical examinationT1X
Symptom-directed physical examination3T1XXXXXXXXXXXXXXXXXX
12-Lead ECG4T1XXXXXXXXX
ABPM trainingT1XX
Initiate ABPM deviceT1XX
Return ABPM device5T1XX
Record ABPM measurements6T1XX
Participant EducationT1
Explain diet and physical activity plan7T1XXXXX
Discuss diet and physical activity progress8T1XXXXX
Participant Administration LogT1
Dispense study drug administration log, instruct in use9T1XXXXXXXXXXXXX
Study drug administration log return and reviewT1XXXXXXXXXXXXXXX
Patient-Reported OutcomesT1
SF-36v2 acute formT1XXXXX
IWQOL-Lite CTT1XXXXX
PGIS for Physical ActivityT1XXXXX
Participant SurveyT1XX10
Clinician-Administered Assessments (Paper)T1
Patient Health Questionnaire-9 (PHQ-9)T1XXXXXXX
C-SSRS screening/baselineT1X
C-SSRS since last visitT1XXXXXXXXXXXXXXXXXX
Laboratory Tests and Sample CollectionsT1
HematologyT1XXXXXX
Hemoglobin A1c (HbA1c)T1XXXXXX
Clinical chemistryT1XXXXXXXX
Lipid panelT1XXXXXXX
UrinalysisT1XXXXX
Serum pregnancyT1X
Follicle-stimulating hormone (FSH)11T1X
Luteinizing hormone (LH)11T1X
Estradiol11T1X
GlucagonT1XX
C-peptideT1XX
CalcitoninT1XXXXXX
Pancreatic amylaseT1XXXXXX
LipaseT1XXXXXX
HIV screening testsT1X
Hepatitis C Virus (HCV) screening testsT1X
Hepatitis B Virus (HBV) screening testsT1X
Pro-C3T1XXX
High sensitivity CRPT1XX
Apo B and Apo C3T1XX
LeptinT1XX
Cytokeratin 18T1XX
eGFR (CKD-EPI)T1XXXX
Urinary albumin/creatinine ratio (UACR)T1XXXX
Pharmacokinetic (PK) sampleT1
Predose12T1XXXXX
Postdose12T1XXXXX
Stored SamplesT1
Exploratory biomarker samplesT1XXXXX
Randomization and DosingT1
IWRST1XXXXXXXXXXXXXXXXXXXX
RandomizationT1X
Dispense study intervention capsules13T1XXXXXXXXXXXXX
Participant returns unused study drugT1XXXXXXXXXXXXX
Assess drug complianceT1XXXXXXXXXXXXXX
▼ Matches across tables no matches to review
Rows that consolidation merged on name similarity, or kept separate from a near match. Whether two rows are the same activity is the reviewer's call: choosing drafts an entry for NCT05051579_consolidation_corrections.json below; nothing is saved from here. Rows merged on an identical name are not listed. Words that only one of the two names prints are marked; the score ignores case, hyphens, slashes, text in parentheses and plural endings.
Draft — new file consolidated/NCT05051579_consolidation_corrections.json; replace each <why>, then re-run consolidation.
▼ Consolidation Metadata Process information
consolidated_at2026-10-03T19:23:24.135053+00:00
source_activity_count71
unified_activity_count71
compression_percent0
match_statsnew: 71
▼ Source Tables 1 tables
tabletypetracktitle / purposeactscolsprops
T1 main_soa Schedule of Activities (SoA)
Main study schedule: screening/lead-in, treatment period, early termination and safety follow-up		 71 20 6
▼ Unified Activities 71 activities
xact_idactivity_name (variations)parentmatch#tablesrow kind
xact-001 Administrative one table 1 T1 section
xact-002 Informed consent Administrative one table 1 T1
xact-003 Inclusion and exclusion criteria review Administrative one table 1 T1
xact-004 Demographics Administrative one table 1 T1
xact-005 Preexisting conditions and medical history Administrative one table 1 T1
xact-006 Concomitant medications Administrative one table 1 T1
xact-007 Substance use (alcohol, caffeine, tobacco use) Administrative one table 1 T1
xact-008 Adverse events (AEs) Administrative one table 1 T1
xact-009 Physical Evaluation one table 1 T1 section
xact-010 Height Physical Evaluation one table 1 T1
xact-011 Weight Physical Evaluation one table 1 T1
xact-012 Waist circumference Physical Evaluation one table 1 T1
xact-013 Vital signs (2 sitting BP and PR measurements) Physical Evaluation one table 1 T1
xact-014 Physical examination Physical Evaluation one table 1 T1
xact-015 Symptom-directed physical examination Physical Evaluation one table 1 T1
xact-016 12-Lead ECG Physical Evaluation one table 1 T1
xact-017 ABPM training Physical Evaluation one table 1 T1
xact-018 Initiate ABPM device Physical Evaluation one table 1 T1
xact-019 Return ABPM device Physical Evaluation one table 1 T1
xact-020 Record ABPM measurements Physical Evaluation one table 1 T1
xact-021 Participant Education one table 1 T1 section
xact-022 Explain diet and physical activity plan Participant Education one table 1 T1
xact-023 Discuss diet and physical activity progress Participant Education one table 1 T1
xact-024 Participant Administration Log one table 1 T1 section
xact-025 Dispense study drug administration log, instruct in use Participant Administration Log one table 1 T1
xact-026 Study drug administration log return and review Participant Administration Log one table 1 T1
xact-027 Patient-Reported Outcomes one table 1 T1 section
xact-028 SF-36v2 acute form Patient-Reported Outcomes one table 1 T1
xact-029 IWQOL-Lite CT Patient-Reported Outcomes one table 1 T1
xact-030 PGIS for Physical Activity Patient-Reported Outcomes one table 1 T1
xact-031 Participant Survey Patient-Reported Outcomes one table 1 T1
xact-032 Clinician-Administered Assessments (Paper) one table 1 T1 section
xact-033 Patient Health Questionnaire-9 (PHQ-9) Clinician-Administered Assessments (Pape one table 1 T1
xact-034 C-SSRS screening/baseline Clinician-Administered Assessments (Pape one table 1 T1
xact-035 C-SSRS since last visit Clinician-Administered Assessments (Pape one table 1 T1
xact-036 Laboratory Tests and Sample Collections one table 1 T1 section
xact-037 Hematology Laboratory Tests and Sample Collections one table 1 T1
xact-038 Hemoglobin A1c (HbA1c) Laboratory Tests and Sample Collections one table 1 T1
xact-039 Clinical chemistry Laboratory Tests and Sample Collections one table 1 T1
xact-040 Lipid panel Laboratory Tests and Sample Collections one table 1 T1
xact-041 Urinalysis Laboratory Tests and Sample Collections one table 1 T1
xact-042 Serum pregnancy Laboratory Tests and Sample Collections one table 1 T1
xact-043 Follicle-stimulating hormone (FSH) Laboratory Tests and Sample Collections one table 1 T1
xact-044 Luteinizing hormone (LH) Laboratory Tests and Sample Collections one table 1 T1
xact-045 Estradiol Laboratory Tests and Sample Collections one table 1 T1
xact-046 Glucagon Laboratory Tests and Sample Collections one table 1 T1
xact-047 C-peptide Laboratory Tests and Sample Collections one table 1 T1
xact-048 Calcitonin Laboratory Tests and Sample Collections one table 1 T1
xact-049 Pancreatic amylase Laboratory Tests and Sample Collections one table 1 T1
xact-050 Lipase Laboratory Tests and Sample Collections one table 1 T1
xact-051 HIV screening tests Laboratory Tests and Sample Collections one table 1 T1
xact-052 Hepatitis C Virus (HCV) screening tests Laboratory Tests and Sample Collections one table 1 T1
xact-053 Hepatitis B Virus (HBV) screening tests Laboratory Tests and Sample Collections one table 1 T1
xact-054 Pro-C3 Laboratory Tests and Sample Collections one table 1 T1
xact-055 High sensitivity CRP Laboratory Tests and Sample Collections one table 1 T1
xact-056 Apo B and Apo C3 Laboratory Tests and Sample Collections one table 1 T1
xact-057 Leptin Laboratory Tests and Sample Collections one table 1 T1
xact-058 Cytokeratin 18 Laboratory Tests and Sample Collections one table 1 T1
xact-059 eGFR (CKD-EPI) Laboratory Tests and Sample Collections one table 1 T1
xact-060 Urinary albumin/creatinine ratio (UACR) Laboratory Tests and Sample Collections one table 1 T1
xact-061 Pharmacokinetic (PK) sample Laboratory Tests and Sample Collections one table 1 T1
xact-062 Predose Pharmacokinetic (PK) sample one table 1 T1
xact-063 Postdose Pharmacokinetic (PK) sample one table 1 T1
xact-064 Stored Samples one table 1 T1 section
xact-065 Exploratory biomarker samples Stored Samples one table 1 T1
xact-066 Randomization and Dosing one table 1 T1 section
xact-067 IWRS Randomization and Dosing one table 1 T1
xact-068 Randomization Randomization and Dosing one table 1 T1
xact-069 Dispense study intervention capsules Randomization and Dosing one table 1 T1
xact-070 Participant returns unused study drug Randomization and Dosing one table 1 T1
xact-071 Assess drug compliance Randomization and Dosing one table 1 T1
▼ Unified Annotations 13 annotations (0% dedup from 13)
Footnote (13)
xannot_idmarkers#textscopepoints to
xannot-001 1 T1:n1 1 For early terminations that occur before the last visit in treatment period, see the activities listed for ET in this table. Shaded columns represent the dose escalation period Weeks 0-16. 3 | 4 | 5 | 6 | 7 (+11)
xannot-002 2 T1:n2 1 Vital signs include pulse rate, blood pressure, and temperature. Vital sign measurements should be collected after participant has been sitting for at least 5 minutes and before obtaining an ECG tracing and before collection of blood samples for laboratory testing (see Section 10.7). Vital signs (2 sitting BP and PR measurements) Section 10.7
xannot-003 3 T1:n3 1 As indicated based on participant status and standard of care. May be performed by qualified personnel per local regulations. Symptom-directed physical examination
xannot-004 4 T1:n4 1 Single central ECGs will be performed at screening and early termination. Central ECGs should be collected in triplicate at all other visits. ECG should be collected prior to collection of blood samples, including PK samples. ECG measurements should be obtained per the instructions in Section 8.2.3. 12-Lead ECG Section 8.2.3
xannot-005 5 T1:n5 1 Participants should return the ABPM device at the conclusion of the 24- to 27-hour monitoring period. Return ABPM device
xannot-006 6 T1:n6 1 At the time participant visit data are uploaded by the site, the ABPM Data Validity Report will be generated and should be reviewed to ensure ≥70% of readings are valid. If <70% of readings are valid, the 24-hour monitoring session should be repeated within the visit window. Record ABPM measurements
xannot-007 7 T1:n7 1 May be performed more frequently based on usual site practices and participant needs. Explain diet and physical activity plan
xannot-008 8 T1:n8 1 May be performed based on participant needs. Discuss diet and physical activity progress
xannot-009 9 T1:n9 1 The date and time of all dose administrations will be recorded in the log by the participant the day prior to a study visit, but may be recorded more frequently depending on site usual practice. Dispense study drug administration log, instruct in use
xannot-010 10 T1:n10 1 The Participant Survey should be administered at early termination if it occurs before 26 weeks. Participant Survey 1 cells
xannot-011 11 T1:n11 1 Collect serum estradiol, FSH, and LH in women whose menopausal status needs to be determined. For participants known to be either premenopausal or postmenopausal, these tests do not need to be collected. Follicle-stimulating hormone (FSH) | Luteinizing hormone (LH) | Estradiol
xannot-012 12 T1:n12 1 PK predose sample should be collected predose (~up to 1 hour predose). PK postdose sample time windows: 3-6 hours postdose (Week 4); 6-12 hours postdose (Week 8), 1-3 hours postdose (Week 16), 3-6 hours postdose (Week 26). Participants may need to return to clinical site for additional PK-specific visits to provide postdose PK samples. Predose | Postdose
xannot-013 13 T1:n13 1 One bottle of capsules is to be dispensed at Visit 3 and at Visit 4. Two bottles of capsules are to be dispensed at Visits 5-9 (during the rest of the dose escalation period). The site pharmacy should clearly label which bottle to take first. At Visits 10-17, 4 bottles of capsules should be dispensed. Dispense study intervention capsules