protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04842240 | 6.0 | Participant Identification | 6.0 Participant Identification | [] |
NCT04842240 | 6.1 | Trial Participants | 6.1 Trial Participants The sample of patients will include all prospective patients who undergo immediate implant based breast reconstruction in the Leeds Breast Unit between August 2020 and September 2021. | [] |
NCT04842240 | 6.2 | Inclusion criteria | 6.2 Inclusion criteria - Female age ≥ 18 years - Skin or nipple sparing mastectomy with immediate implant based reconstruction for cancer or for risk reduction (e.g. BRCA mutation) - Unilateral or bilateral mastectomy - Implant or expander based immediate reconstruction - Able to read and understand questionnaire in En... | [] |
NCT04842240 | 6.3 | Exclusion criteria | 6.3 Exclusion criteria - Male or transgender - Skin or nipple sparing mastectomy alone with no reconstruction - Delayed reconstruction - Autologous reconstruction - Cognitive impairment or inability to provide informed consent | [] |
NCT04842240 | 6.4 | Participants in the local service evaluation | 6.4 Participants in the local service evaluation Patients who have already completed the questionnaires through their participation in a local service evaluation, will also be approached to ask to participate. They will be provided with a separate patient information sheet which explains the difference between the serv... | [] |
NCT04842240 | 7.0 | Trial Procedures | 7.0 Trial Procedures | [] |
NCT04842240 | 7.1 | Recruitment | 7.1 Recruitment All eligible patients will be identified at the Leeds Breast diagnostic MDT meetings and through clinics. Those planned for a mastectomy and implant based reconstruction are offered the option of completing the BREAST-Q as part of routine care. The direct clinical team will discuss this with the patient... | [] |
NCT04842240 | 7.2 | Informed Consent | 7.2 Informed Consent The participant must personally sign and date the latest approved version of the Informed Consent form before any study specific procedures are performed. It is the responsibility of the Chief Investigator (or designee as listed on the Site Responsibilities Form) to obtain written informed consent ... | [] |
NCT04842240 | 7.2.1 | Patients who withdraw consent | 7.2.1 Patients who withdraw consent Patients are free to withdraw from the study at any time. | [] |
NCT04842240 | 7.3 | Baseline Assessments | 7.3 Baseline Assessments Once written informed consent is obtained, participants will be asked to complete the baseline questionnaire. Clinical data will be obtained from medical notes by the clinician and/or research team and will include (but not limited to) gender, age, diagnostic details, comorbidities, smoking sta... | [
"Timepoint 0",
"After consent but prior to surgery"
] |
NCT04842240 | 7.4 | Subsequent Timepoints | 7.4 Subsequent Timepoints
Timepoint 1
On completion of surgery and discharge from hospital All study participants will be asked to complete the BREAST-Q questionnaire 2 weeks (+1 week) after having surgery. Patients will be due to be seen at a routine outpatient appointment and will be offered the opportunity to comp... | [
"Timepoint 1",
"On completion of surgery and discharge from hospital",
"Timepoint 2",
"Timepoint 3"
] |
NCT04842240 | 7.5 | Patient Outcome Measures (see appendix) | 7.5 Patient Outcome Measures (see appendix) Participants in the study will complete the same measures on paper to ensure comparison between the timepoints. The questionnaire will be completed at baseline, 2 weeks and 3 and 12 months post-surgery. | [] |
NCT04842240 | 7.6 | Discontinuation/Withdrawal of Participants from Study | 7.6 Discontinuation/Withdrawal of Participants from Study Each participant has the right to withdraw from the study at any time. In addition, the Investigator may discontinue a participant from the trial at any time if the Investigator considers it necessary for any reason including: - Withdrawal of Consent - If surger... | [] |
NCT04842240 | 8 | Statistics | 8 Statistics As we are exploring patient perceived outcomes and not evaluating a new intervention, a power calculation is not required to calculate sample size. Based on the rate of immediate implant based reconstructions performed in the Leeds Breast and Reconstructive unit, we estimate that approximately 60 patients ... | [] |
NCT04842240 | 8.1 | Sample size and recruitment rate | 8.1 Sample size and recruitment rate This is a single centre study with a planned minimum sample size of 60 participants. We have allowed a 2 year period for recruitment. | [] |
NCT04842240 | 8.2 | General Considerations | 8.2 General Considerations Statistical analysis of the recruitment and attrition rates, data collection, measures and outcome data is the responsibility of the Chief Investigator (assisted by the study team). The questionnaire score for each participant will be converted into a Rasch scale (scores 0- 100) as per BREAST... | [] |
NCT04842240 | 8.3 | Recruitment, Follow up and Attrition | 8.3 Recruitment, Follow up and Attrition The feasibility of the recruitment process will be evaluated by using the screening logs, eligibility and consent processes. If reasons for ineligibility and non-participation have been provided, these will be summarised. Follow up retention, including the number of participants... | [] |
NCT04842240 | 8.4 | Clinical Measure and Processes | 8.4 Clinical Measure and Processes Telephone calls and contact with hospital staff to report problems such as pain or infection symptoms will be summarised. | [] |
NCT04842240 | 8.5 | Patient Outcome Measures | 8.5 Patient Outcome Measures Patient outcome measures will be summarised for each time point. Any differences between the two groups will be analysed where possible. All analyses will be used to help plan a future advice and information for patients undergoing implant based reconstruction. | [] |
NCT04842240 | 9 | Data Management | 9 Data Management Data collection will occur in accordance with GCP, Caldicott principles and the General Data Protection Regulation (GDPR) 2018, and will work in line with NHS confidentiality guidelines and codes of conduct. All questionnaires will be fully anonymised and contain no patient identifiable details. Anony... | [] |
NCT04842240 | 9.1 | Source Data | 9.1 Source Data Source documents are where data is first recorded, and from which participants' data are obtained. These will include, but are not limited to, hospital records (from which medical history and previous and concurrent medication may be summarised into the CRF), clinical and office charts, laboratory and p... | [] |
NCT04842240 | 9.2 | Access to Data | 9.2 Access to Data Direct access will be granted to authorised representatives from the Sponsor, host institution and the regulatory authorities to permit trial-related monitoring, audits and inspections. | [] |
NCT04842240 | 9.3 | Data Recording and Record Keeping | 9.3 Data Recording and Record Keeping
General All information collected during the course of the trial will be kept strictly confidential. Information will be held securely on paper and electronically at the Leeds Teaching Hospitals NHS Trust. The Leeds Breast Unit will comply with all aspects of the Data Protection A... | [
"General",
"Data Collection",
"Data Completeness"
] |
NCT04842240 | 10 | Safety | 10. Safety There are no pre-defined safety end-points for this study. However, any adverse events which occur as a result of normal care will be reported to the study team. The majority of the research will involve completion of a simple and well validated questionnaire, so there will be no physical pain, discomfort or... | [] |
NCT04842240 | 11 | Ethical and Regulatory Considerations | 11. Ethical and Regulatory Considerations | [] |
NCT04842240 | 11.1 | Approvals | 11.1 Approvals This study is a single centre research study taking place at Leeds only. The protocol, informed consent forms and participant information sheets will be submitted to an appropriate Research Ethics Committee (REC), Health Research Authority (HRA) and host institution(s) for written approval. The Investiga... | [] |
NCT04842240 | 11.2 | Reporting | 11.2 Reporting The CI shall submit once a year throughout the clinical trial, or on request, an Annual Progress Report to the REC, host organisation and Sponsor. In addition, an End of Trial notification and final report will be submitted to the REC, host organisation and Sponsor. | [] |
NCT04842240 | 11.3 | Patient Confidentiality | 11.3 Patient Confidentiality The study staff will ensure that the participants' anonymity is maintained. The participants will be identified only by initials and a participants ID number on the CRF and any electronic database. All documents will be stored securely and only accessible by authorised personnel. The trial ... | [] |
NCT04842240 | 12 | Public and Patient Involvement | 12. Public and Patient Involvement Discussions were had with local patients who have undergone breast reconstruction regarding their experiences of the procedure and how they made their choice of type of reconstruction. One patient has reviewed all the study paperwork including the protocol, information sheet and conse... | [] |
NCT04842240 | 13 | Archiving | 13. Archiving In line with the principles of GCP/UK Clinical trial Regulations guidelines, at the end of the trial, data will be securely archived at the centre for a minimum of 15 years. Arrangements for confidential destruction will then be made. If a patient withdraws consent for their data to be used, it will be co... | [] |
NCT04842240 | 14 | Insurance | 14. Insurance NHS indemnity through the Clinical Negligence Scheme for Trusts (CNST). | [] |
NCT04842240 | 15 | Publication Policy | 15. Publication Policy Credit for the main results will be given to all those who have collaborated in the trial, as its success depends on collaboration and participation. Requirements for authorship for manuscripts submitted to medical journals will guide authorship decisions. These state that authorship credit shoul... | [] |
NCT04842240 | 16 | References | 16. References - 1. Jeevan, R., et al., Findings of a national comparative audit of mastectomy and breast reconstruction surgery in England. J Plast Reconstr Aesthet Surg, 2014. 67(10): p. 1333-44. - 2. Jeevan, R., et al., National trends and regional variation in immediate breast reconstruction rates. Br J Surg, 2016.... | [] |
NCT04867785 | 1 | Protocol Summary | 1. Protocol Summary | [] |
NCT04867785 | 1.1 | Synopsis | 1.1. Synopsis Protocol Title: A Phase 2 Study of Once-Weekly LY3437943 Compared with Placebo and Dulaglutide in Participants with Type 2 Diabetes Short Title: Effect of LY3437943 Versus Placebo and Dulaglutide in Participants with Type 2 Diabetes
Rationale: Epidemiological studies have shown that type 2 diabetes (T2D)... | [
"Rationale:",
"Overall Design",
"Number of Participants:",
"Intervention Groups and Duration:"
] |
NCT04867785 | 1.2 | Schema | 1.2. Schema  Abbreviations: Dula = dulaglutide; LY = LY3437943; PBO = Placebo. | [] |
NCT04867785 | 1.3 | Schedule of Activities (SoA) | 1.3. Schedule of Activities (SoA) The Schedule of Activities described below should be followed for all participants enrolled in Study GZBD. However, for those participants whose participation in this study is affected by exceptional circumstances (such as pandemics or natural disasters), please refer to Section [10.12... | [
"Notes:",
"Pharmacokinetic Schedule of Events"
] |
NCT04867785 | 2 | Introduction | 2. Introduction | [] |
NCT04867785 | 2.1 | Study Rationale | 2.1. Study Rationale Epidemiological studies have shown that T2D and obesity are tightly associated (Marrero 2009; Verma and Hussain 2017). The ongoing global obesity epidemic increases the incidence of T2D and other comorbidities, including hyperlipidemia and hypertension resulting in an increased incidence of chronic... | [] |
NCT04867785 | 2.2 | Background | 2.2. Background Type 2 diabetes is characterized by impaired glycemic control due to resistance in the peripheral tissues to insulin actions and inadequate insulin secretion caused by -cell failure (Zheng et al. 2018). Type 2 diabetes is commonly associated with comorbidities such as obesity, hypertension, and dyslipid... | [
"Structure of LY3437943",
"Nonclinical data with efficacy and toxicology",
"Summary of clinical studies"
] |
NCT04867785 | 2.3 | Benefit/Risk Assessment | 2.3. Benefit/Risk Assessment This section summarizes the key observations from the completed or ongoing Phase 1 trials with LY3437943. More detailed information about the known and expected benefits and risks and reasonably expected adverse events of LY3437943 may be found in the Investigator's Brochure (IB). Informati... | [] |
NCT04867785 | 2.3.1 | Risk Assessment | 2.3.1. Risk Assessment Most common AEs seen in clinical trials of LY3437943 have been those related to the GI organ system. The GI AEs, as well as those related to pancreatic safety, hypoglycemia, vital signs, allergic and hypersensitivity reactions, and thyroid C-cell effects are safety topics of special interest in i... | [] |
NCT04867785 | 2.3.2 | Benefit Assessment | 2.3.2. Benefit Assessment LY3437943 is a tri-agonist of the GIP, GLP-1, and glucagon receptors that is currently in early clinical development. Full assessment of its potential benefits has not been completed. The purpose of this Phase 2 trial is to provide initial efficacy assessment in participants with T2D, in addit... | [] |
NCT04867785 | 2.3.3 | Overall Benefit: Risk Conclusion | 2.3.3. Overall Benefit: Risk Conclusion The data from Phase 1 studies indicate that the safety profile of LY3437943 is consistent with the safety profile of other GLP-1 and GIP/GLP-1 RAs. No additional risks are anticipated. Considering the measures to minimize risk to participants included in the study protocol, poten... | [] |
NCT04867785 | 3 | Objectives and Endpoints | 3. Objectives and Endpoints | Objectives | Estimands/Endpoints | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT04867785 | 4 | Study Design | 4. Study Design | [] |
NCT04867785 | 4.1 | Overall Design | 4.1. Overall Design Study GZBD is a Phase 2, multicenter, randomized, double-blinded, parallel, placebo- and active comparator-controlled 36-week study, with the primary outcome at 24 weeks, to investigate the safety and efficacy of LY3437943 in participants with T2D who failed to achieve adequate glycemic control on d... | [] |
NCT04867785 | 4.1.1 | Overview of Study Periods | 4.1.1. Overview of Study Periods
Screening Period
Visit 1 The purpose of screening procedures at Visit 1 is to establish initial eligibility and to obtain blood samples for laboratory assessments needed to confirm eligibility. The participant must sign the informed consent form (ICF) before the study procedures are p... | [
"Screening Period",
"Visit 1",
"Visit 2",
"Visit 3 Randomization",
"Treatment Period",
"Dose-Escalation Period (Visits 4-8)",
"Maintenance Period (Visits 9-13)",
"Early Discontinuation Visit",
"Safety Follow-up Period",
"Visit 801"
] |
NCT04867785 | 4.2 | Scientific Rationale for Study Design | 4.2. Scientific Rationale for Study Design Study GZBD is a Phase 2 study designed to examine the glucose and body weight-lowering efficacy and safety of LY3437943 QW (dose ranging from 0.5 to 12 mg) compared with placebo and dulaglutide 1.5 mg during the 36-week treatment period in participants with T2D who have inadeq... | [] |
NCT04867785 | 4.3 | Justification for Dose | 4.3. Justification for Dose LY3437943 maintenance doses of 0.5, 4, 8, and 12 mg, administered subcutaneously QW, were selected based on - Safety and tolerability of LY3437943 in healthy subjects and T2D patients in the Phase 1 studies GZBA (0.1 to 6 mg) and GZBB (0.5 to 12 mg), respectively. - PK/PD modeling based on p... | [] |
NCT04867785 | 4.4 | End of Study Definition | 4.4. End of Study Definition A participant is considered to have completed the study if he or she has completed all required phases of the study including the last visit or the last scheduled procedure shown in the SoA (Section [1.3\)](#page-11-0). The end of the study is defined as the date of the last visit of the la... | [] |
NCT04867785 | 5 | Study Population | 5. Study Population Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as protocol waivers or exemptions, is not permitted. | [] |
NCT04867785 | 5.1 | Inclusion Criteria | 5.1. Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria are met:
Age 1. Participant must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
Type of Participant and Disease Characteristics - 2. Have been diagnosed with T2D based ... | [
"Age",
"Type of Participant and Disease Characteristics",
"Sex",
"Informed Consent"
] |
NCT04867785 | 5.2 | Exclusion Criteria | 5.2. Exclusion Criteria Participants are excluded from the study if any of the following criteria applies:
Medical Conditions - 10. Have type 1 diabetes mellitus (T1DM) - 11. Have history of ketoacidosis or hyperosmolar state/coma - 12. Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or sev... | [
"Medical Conditions",
"Prior/Concomitant Therapy",
"For example",
"Prior/Concurrent Clinical Study Experience",
"Other Exclusions"
] |
NCT04867785 | 5.3 | Lifestyle Considerations | 5.3. Lifestyle Considerations Per the SoA (Section [1.3\)](#page-11-0), qualified medical staff will provide diabetes management counseling, which will include instructions on diet and exercise and education about the signs, symptoms, and treatment of hypoglycemia and hyperglycemia, should it occur. Throughout the stud... | [] |
NCT04867785 | 5.3.1 | Meals and Dietary Restrictions | 5.3.1. Meals and Dietary Restrictions Participants should continue their usual meal plan (with consistent meal size and time of day) throughout the course of the study, as agreed with the investigator or his or her designee. Per Inclusion Criterion 5 (Section [5.1\)](#page-28-1), participants should not initiate a stru... | [] |
NCT04867785 | 5.3.2 | Activity and Physical Exercise | 5.3.2. Activity and Physical Exercise Participants will be advised to maintain their regular levels of physical activity/exercise during the study; strenuous exercise within 24 hours prior to all visits should be avoided. | [] |
NCT04867785 | 5.4 | Screen Failures | 5.4. Screen Failures Screen failures are defined as participants who consent to participate in the clinical study but are not subsequently enrolled in the study. A minimal set of screen failure information is required to ensure transparent reporting of screen failure participants to meet the Consolidated Standards of R... | [] |
NCT04867785 | 6 | Study Intervention | 6. Study Intervention Study intervention is defined as any investigational intervention(s), marketed product(s), placebo, or medical device(s) intended to be administered to/used by a study participant according to the study protocol. | [] |
NCT04867785 | 6.1 | Study Intervention(s) Administered | 6.1. Study Intervention(s) Administered The following study interventions will be administered: - LY3437943 vial containing 12 mg/2 mL of solution or - Placebo to match LY3437943 vial containing 2 mL of solution and - Dulaglutide 1.5 mg/0.5 mL single-dose pen or - Placebo to match Dulaglutide in a 0.5 mL single-dose pe... | [] |
NCT04867785 | 6.1.1 | Medical Devices | 6.1.1. Medical Devices The combination products provided for use in the study are marketed prefilled single-use pens for dulaglutide and prefilled single-dose placebo pens for dulaglutide placebo. Any medicaldevice incidents, including those resulting from malfunctions of the device, must be detected, documented, and r... | [] |
NCT04867785 | 6.2 | Preparation/Handling/Storage/Accountability | 6.2. Preparation/Handling/Storage/Accountability - The investigator or designee must confirm appropriate storage conditions have been maintained during transit for all study intervention received and any discrepancies are reported and resolved before use of the study intervention. - Only participants enrolled in the st... | [] |
NCT04867785 | 6.3 | Measures to Minimize Bias: Randomization and Blinding | 6.3. Measures to Minimize Bias: Randomization and Blinding At Visit 3, participants who meet all criteria for enrollment will be randomized to 1 of the 6 study treatment groups and 2 different starting dose subgroups within the 4 and 8 mg LY3437943 treatment groups. Assignment to treatment groups and starting dose subg... | [] |
NCT04867785 | 6.4 | Study Intervention Compliance | 6.4. Study Intervention Compliance Participant compliance with study interventions will be assessed at each visit. Compliance will be assessed by direct questioning and counting of unused study interventions and/or empty cartons returned. Study intervention compliance will be determined by the following: - Study interv... | [] |
NCT04867785 | 6.5 | Concomitant Therapy | 6.5. Concomitant Therapy Participants will be permitted to use concomitant medications that they require during the study, except certain medications that may interfere with the assessment of efficacy and safety of the study treatments. The table below provides a summary of criteria for use of concomitant medications t... | [] |
NCT04867785 | 6.5.1 | Glucose-lowering Agents | 6.5.1. Glucose-lowering Agents The only concomitant antihyperglycemic medication permitted at baseline is metformin. Metformin dose must be stable for at least 3 months prior to screening. - Participants who enter the study on diet and exercise alone will not be allowed to initiate metformin therapy after study entry, ... | [] |
NCT04867785 | 6.5.2 | Other Concomitant Medications | 6.5.2. Other Concomitant Medications Treatment with medications that are excluded per entry criteria (Section [5.2,](#page-29-0) Exclusion Criteria) is not permitted during the trial. Doses of prescription medications for treatment of concurrent medical conditions should remain constant during the study unless an adjus... | [] |
NCT04867785 | 6.5.3 | Management of Participants with Gastrointestinal Symptoms | 6.5.3. Management of Participants with Gastrointestinal Symptoms Consistent with other incretins, in Phase 1 studies, the most reported TEAEs for participants receiving LY3437943 or dulaglutide were nausea, vomiting, and diarrhea. To mitigate GI symptoms and manage participants with intolerable GI AEs, the investigator... | [] |
NCT04867785 | 6.6 | Dose Modification | 6.6. Dose Modification Study drug administration should follow the schedule provided in Section [1.3](#page-11-0) (SoA) and Section [4.1.1](#page-24-0) (Overview of Study Periods). Dose modification is not allowed, except for - temporary dose interruption to address tolerability or other clinically important safety iss... | [] |
NCT04867785 | 6.6.1 | Temporary Interruption of Study Drug | 6.6.1. Temporary Interruption of Study Drug In certain situations, participants may need to temporarily interrupt study drug, for example due to - occurrence of intolerable GI AEs, and - other AEs deemed by the investigator severe enough to warrant dosing interruption. If the reason for temporary dosing interruption is... | [] |
NCT04867785 | 6.6.2 | Dose Reductions Indicated to Ensure Participant Safety | 6.6.2. Dose Reductions Indicated to Ensure Participant Safety In addition to the dose modifications described in Section [6.6,](#page-42-0) there may be situations when dose interruptions occur, where only dose reduction (without interrupting dosing) would be appropriate (for example, clinically significant changes in ... | [] |
NCT04867785 | 6.7 | Intervention after the End of the Study | 6.7. Intervention after the End of the Study LY3437943 will not be made available to participants after conclusion of the study. | [] |
NCT04867785 | 7 | Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal | 7. Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal | [] |
NCT04867785 | 7.1 | Discontinuation of Study Intervention | 7.1. Discontinuation of Study Intervention In rare instances, it may be necessary for a participant to permanently discontinue (definitive discontinuation) study interventions. If study interventions are definitively discontinued, the participant will remain in the study to be evaluated for all planned efficacy and saf... | [
"participant decision",
"clinical considerations",
"discontinuation due to a hepatic event or liver test abnormality"
] |
NCT04867785 | 7.2 | Participant Discontinuation/Withdrawal from the Study | 7.2. Participant Discontinuation/Withdrawal from the Study A participant may withdraw from the study: - at any time at his or her own request - at the request of his or her designee (for example, parents or legal guardian) - at the discretion of the investigator for safety, behavioral, compliance, or administrative rea... | [] |
NCT04867785 | 7.3 | Lost to Follow-Up | 7.3. Lost to Follow-Up A participant will be considered lost to follow-up if he or she repeatedly fails to return for scheduled visits and is unable to be contacted by the study site. Site personnel or designee are expected to make diligent attempts to contact participants who fail to return for a scheduled visit or we... | [] |
NCT04867785 | 8 | Study Assessments and Procedures | 8. Study Assessments and Procedures - Study procedures and their timing are summarized in the SoA. - Immediate safety concerns should be discussed with the sponsor immediately upon occurrence or awareness to determine if the participant should continue or discontinue study intervention. - Adherence to the study design ... | [] |
NCT04867785 | 8.1 | Efficacy Assessments | 8.1. Efficacy Assessments
Primary: The primary efficacy measure is change from baseline in HbA1c, as determined by the central laboratory.
Secondary: The following secondary efficacy measures will be collected at the times shown in the SoA. - HbA1c as determined by the central laboratory - Fasting blood glucose (FBG)... | [
"Primary:",
"Secondary:",
"Exploratory:"
] |
NCT04867785 | 8.2 | Safety Assessments | 8.2. Safety Assessments Planned time points for all safety assessments are provided in the SoA. | [] |
NCT04867785 | 8.2.1 | Physical Examinations | 8.2.1. Physical Examinations For each participant, measurements including height, weight, and waist circumference should be conducted according to SoA, and following the study-specific recommendations included in Section [10.9.](#page-99-0) A complete physical examination will include, at a minimum, assessments of skin... | [] |
NCT04867785 | 8.2.2 | Vital Signs | 8.2.2. Vital Signs For each participant, vital sign measurements should be conducted according to SoA, and following the study-specific recommendations included in Section [10.9.](#page-99-0) Any clinically significant findings from vital sign measurement that result in a diagnosis and that occur after the participant ... | [] |
NCT04867785 | 8.2.3 | Electrocardiograms | 8.2.3. Electrocardiograms For each participant, a single 12-lead ECG should be collected according to Section [1.3](#page-11-0) (for details, please see Section [10.9.](#page-99-0) In addition, tracings collected at the baseline, 24 and 36 weeks will be assessed qualitatively by a blinded cardiologist. Electrocardiogra... | [] |
NCT04867785 | 8.2.4 | Clinical Safety Laboratory Assessments | 8.2.4. Clinical Safety Laboratory Assessments See Section [10.2](#page-77-0) for the list of clinical laboratory tests to be performed and to the SoA for the timing and frequency. The investigator must review the laboratory results, document this review, and report any clinically relevant changes occurring during the s... | [] |
NCT04867785 | 8.2.5 | Safety Monitoring | 8.2.5. Safety Monitoring Lilly will periodically review evolving aggregate safety data within the study by appropriate methods. The study team will review safety reports in a blinded fashion (for applicable blinded study period) according to the schedule provided in the Trial-Level Safety Review plan. Lilly will also r... | [] |
NCT04867785 | 8.2.5.1 | Hepatic Safety Monitoring | 8.2.5.1. Hepatic Safety Monitoring
Close hepatic monitoring If any of the following abnormalities occurred, laboratory tests (Section [10.5\)](#page-94-0), including ALT, AST, ALP, TBL, direct bilirubin, gamma-glutamyltransferase, and creatine kinase, should be repeated within 48 to 72 hours to confirm the abnormality... | [
"Close hepatic monitoring",
"Comprehensive hepatic evaluation",
"Additional hepatic data collection (hepatic safety CRF) in study participants who have abnormal liver tests during the study"
] |
NCT04867785 | 8.3 | Adverse Events, Serious Adverse Events, and Product Complaints | 8.3. Adverse Events, Serious Adverse Events, and Product Complaints The definitions of the following events can be found in Section [10.3](#page-82-0) Appendix 3. - AEs - SAEs, and - Product complaints (PCs). These events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the parti... | [] |
NCT04867785 | 8.3.1 | Timing and Mechanism for Collecting Events | 8.3.1. Timing and Mechanism for Collecting Events The following table describes the timing, deadlines, and mechanism for collecting events. | Event | CollectionStart | CollectionStop | Timing for Reporting toSponsor or Designee | Mechanism forReporting | Back-UpMethod ofReporting | |---------------|--------------------... | [] |
NCT04867785 | 8.3.2 | Adverse Events of Special Interest | 8.3.2. Adverse Events of Special Interest The following are adverse events that will be adjudicated by an external adjudication committee: - pancreatitis (see Section [8.3.2.3\)](#page-58-1) - major adverse cardiovascular events (see Section [8.3.2.5\)](#page-60-0), and - deaths. The following are additional adverse ev... | [] |
NCT04867785 | 8.3.2.1 | Hypoglycemia | 8.3.2.1. Hypoglycemia Upon ICF signing, all participants will be educated about signs and symptoms of hypoglycemia, how to treat hypoglycemia, and how to collect appropriate information for each episode of hypoglycemia. Participants who develop persistent or recurrent unexplained hypoglycemia during the treatment perio... | [
"Level 1 hypoglycemia:",
"Level 2 hypoglycemia:",
"Level 3 hypoglycemia:",
"Nocturnal hypoglycemia:"
] |
NCT04867785 | 8.3.2.2 | Severe Persistent Hyperglycemia | 8.3.2.2. Severe Persistent Hyperglycemia An additional glucose-lowering intervention should be considered by the investigator for participants with any persistent severe hyperglycemia, defined as meeting any of the following criteria during the treatment period: During the first 8 weeks postrandomization (between Visit... | [] |
NCT04867785 | 8.3.2.3 | Pancreatitis | 8.3.2.3. Pancreatitis
Diagnosis of acute pancreatitis Acute pancreatitis is an AE of interest in all studies with LY3437943, including this study. The diagnosis of acute pancreatitis requires 2 of the following 3 features (Banks and Freeman 2006; Kouzumi 2006): abdominal pain, characteristic of acute pancreatitis (tha... | [
"Diagnosis of acute pancreatitis",
"Discontinuation for acute pancreatitis",
"Case adjudication and data entry",
"Asymptomatic elevation of pancreatic amylase and/or lipase"
] |
NCT04867785 | 8.3.2.4 | Thyroid Malignancies and C-Cell Hyperplasia | 8.3.2.4. Thyroid Malignancies and C-Cell Hyperplasia Individuals with personal or family history of MTC and/or MEN2 will be excluded from the study. Participants who are diagnosed with MTC and/or MEN2 during the study will have study drug stopped and should continue follow-up with an endocrinologist. Additionally, part... | [
"Calcitonin Measurements in Participants with eGFR ≥60 mL/min/1.73 m2",
"Calcitonin Measurement in Participants with eGFR 2"
] |
NCT04867785 | 8.3.2.5 | Major Adverse Cardiovascular Events | 8.3.2.5. Major Adverse Cardiovascular Events Nonfatal cardiovascular AEs will be adjudicated by a committee of physicians external to Lilly with cardiology expertise. This committee will be blinded to treatment assignment. The nonfatal cardiovascular AEs to be adjudicated include - myocardial infarction - hospitalizati... | [] |
NCT04867785 | 8.3.2.6 | Supraventricular Arrhythmias and Cardiac Conduction Disorders | 8.3.2.6. Supraventricular Arrhythmias and Cardiac Conduction Disorders Treatment-emergent cardiac conduction disorders will be further evaluated. Participants who develop any event from these groups of disorders should undergo an ECG, which should be submitted to the central reading center. Additional diagnostic tests ... | [] |
NCT04867785 | 8.3.2.7 | Deaths | 8.3.2.7. Deaths All deaths will be adjudicated by a committee of physicians external to Lilly. This committee will be blinded to treatment assignment. | [] |
NCT04867785 | 8.3.2.8 | Hypersensitivity Reactions | 8.3.2.8. Hypersensitivity Reactions Many drugs, particularly biologic agents, carry the risk of systemic hypersensitivity reactions. If such a reaction occurs, additional data describing each symptom should be provided to the sponsor in the eCRF. Sites should have appropriately trained medical staff and appropriate med... | [] |
NCT04867785 | 8.3.2.9 | Injection Site Reactions | 8.3.2.9. Injection Site Reactions Symptoms of a local injection site reaction (ISR) may include erythema, induration, pain, pruritus, and edema. If an injection site event is reported, the AE will be recorded, and additional data will be provided to the sponsor in the eCRF. At the time of occurrence of severe or seriou... | [] |
NCT04867785 | 8.3.2.10 | Hepatobiliary Disorders | 8.3.2.10. Hepatobiliary Disorders All events of TE biliary colic, cholecystitis, or other suspected events related to gallbladder disease should be evaluated and additional diagnostic tests performed, as needed. In cases of elevated liver markers, hepatic monitoring should be initiated as outlined in Section [8.2.5.1.]... | [] |
NCT04867785 | 8.3.2.11 | Severe Gastrointestinal Adverse Events | 8.3.2.11. Severe Gastrointestinal Adverse Events LY3437943 and dulaglutide may cause severe GI AEs, such as nausea, vomiting, and diarrhea. Information about severe GI AEs as well as antiemetic or antidiarrheal use will be collected in the AE and concomitant medications eCRFs, respectively. For detailed information con... | [] |
NCT04867785 | 8.3.2.12 | Acute Renal Events | 8.3.2.12. Acute Renal Events Renal safety will be assessed based on repeated renal functional assessment as well as assessment of AEs suggestive of acute renal failure or worsening of preexisting chronic renal failure. Gastrointestinal AEs have been reported with LY3437943, including nausea, diarrhea, and vomiting. Thi... | [] |
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