chufangao/CTO huggingface dataset:
Clinical trial NCT03923361: Neural and Antidepressant Effects of Propofol (Phase 2)
Official title: Neural and Antidepressant Effects of Propofol (Phase 2)
Sponsor: University of Utah (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Change in study design based on phase 1 data collection; patient burden was not feasible
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-16
Primary completion date: 2024-03-31
Completion date: 2024-07-31
Clinical trial NCT02849743: Intranasal Oxytocin in Hypothalamic Obesity
Official title: Intranasal Oxytocin to Promote Weight Loss in Children, Adolescents, and Adults With Brain Tumors and Hypothalamic Obesity Syndrome
Sponsor: Children's Hospital of Philadelphia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-10-31
Primary completion date: 2021-04-30
Completion date: 2022-05-31
Limitations and caveats: A new package insert for intranasal oxytocin was released indicating a possible risk for QTc prolongation when administered with other medications known to prolong the QTc. In response with advise from our study cardiologist, we revised exclusion criteria, and added post-dose ECG studies to monitor acute effects. These activities impacted recruitment, as did the COVID-19 pandemic, thus target sample size is less than originally planned (see statistical plan for details).
Clinical trial NCT02263898: Intermittent LGX818 and MEK162 in Treating Patients With Metastatic Melanoma Who Have BRAFV600 Mutations
Official title: Biomarkers of Durable Response With Intermittent Therapy With LGX818 and MEK162 Combined Therapy in Patients With BRAF Mutant Metastatic Melanoma
Sponsor: Jonsson Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: closed without enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-01-31
Primary completion date: 2019-12-31
Completion date: 2020-12-31
Clinical trial NCT01940471: Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen
Official title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Positive, Chronic Hepatitis B
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 875.0 (ACTUAL)
Number of arms: 3.0
Start date: 2013-09-11
Primary completion date: 2015-11-16
Completion date: 2022-10-13
Baseline population: Safety Analysis Set: Participants who received at least 1 dose of study drugs.
Plan to share individual participant data: YES
IPD sharing description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
IPD time frame: 18 months after study completion
IPD access criteria: A secured external environment with username, password, and RSA code.
Clinical trial NCT03276962: Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
Official title: Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or With-out Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 1500.0 (ACTUAL)
Number of arms: 5.0
Start date: 2017-09-28
Primary completion date: 2019-11-04
Completion date: 2022-11-14
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT05299359: A Single Heterologous Booster Vaccination Study of TAK-019 in Healthy Japanese Adults (COVID-19)
Official title: A Phase 3, Single Arm, Open-Label Trial to Evaluate the Immunogenicity and Safety of a Single Heterologous Booster Vaccination of TAK-019 in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 150.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-15
Primary completion date: 2022-06-11
Completion date: 2023-10-18
Baseline population: The safety analysis set included all participants who received at least 1 dose of the treatment.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT01794572: Phase 1-2 Study of Total Bone Marrow Irradiation With Helicoidal Tomotherapy in 1st Myeloma Relapse
Official title: Phase 1-2 Study of the Combination of Escalated Total Bone Marrow Irradiation (TBMI) by Helicoidal Tomotherapy and a Fixed High-dose Melphalan (140 mg/m²) Followed by Peripheral Stem Cell Rescue (PSC) in First Relapsed Multiple Myeloma.
Acronym: TOMMY
Sponsor: Institut Cancerologie de l'Ouest (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Low patient recruitement rate and modification of the therapeutic standard
Enrollment: 13.0 (ACTUAL)
Number of arms: 1.0
Start date: 2013-04-24
Primary completion date: 2020-01-07
Completion date: 2020-01-07
Plan to share individual participant data: NO
Clinical trial NCT05073679: Oral Naltrexone In Pediatric Eating Disorders
Official title: A Double-Blind Placebo-Controlled Evaluation of Effectiveness of Oral Naltrexone in Management of Adolescent Eating Disorders
Acronym: ONPED
Sponsor: Milton S. Hershey Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Low enrollment numbers, pharmacy not able to acquire sufficient study article component (methylcellulose) due to manufacturer backorder
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-22
Primary completion date: 2024-05-21
Completion date: 2024-05-21
Plan to share individual participant data: NO
IPD sharing description: No participant data is planned to be shared at the moment to protect patient privacy, as participants are all enrolled in a partial hospitalization program for mental health conditions.
Clinical trial NCT03201458: Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer
Official title: A Randomized Phase 2 Study of Atezolizumab in Combination With Cobimetinib Versus Atezolizumab Monotherapy in Participants With Unresectable Cholangiocarcinoma
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 86.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-02-08
Primary completion date: 2020-08-07
Completion date: 2024-02-19
Clinical trial NCT01316146: Administration of T Lymphocytes for Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma (CART CD30)
Official title: Phase I Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor for Relapsed CD30+ Hodgkin's Lymphoma and CD30+ Non-Hodgkin's Lymphoma (CART CD30)
Sponsor: UNC Lineberger Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study never truly opened to accrual at UNC. Study and data were transfered to UNC as the IND for the study was transfered to UNC. IRB closed the study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2011-10-03
Primary completion date: 2016-01-28
Completion date: 2022-05-04
Plan to share individual participant data: NO
Clinical trial NCT03204617: Safety and Immunogenicity Study of DNA.HTI, MVA.HTI and ChAdOx1.HTI in HIV-1-positive Patients (AELIX-002)
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability and Immunogenicity Study of Candidate HIV-1 Vaccines DNA.HTI, MVA.HTI and ChAdOx1.HTI in Early Treated HIV-1 Positive Individuals
Sponsor: Aelix Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-07
Primary completion date: 2020-07-01
Completion date: 2021-03-10
Plan to share individual participant data: NO
Clinical trial NCT04817332: STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19
Official title: A Randomised Double-blind Placebo-controlled Trial of Brensocatib (INS1007) in Patients With Severe COVID-19
Acronym: STOP-COVID19
Sponsor: University of Dundee (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 406.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-05
Primary completion date: 2021-02-28
Completion date: 2021-02-28
Baseline population: Intention to treat population
Plan to share individual participant data: NO
Clinical trial NCT03369912: A Study to Evaluate CSJ148 in Pregnant Women With Primary HCMV Infection
Official title: A Multicenter, Randomized, Patient, Investigator and Sponsor Blinded, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of CSJ148 in Pregnant Women With Primary HCMV Infection
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Company decision to withdraw before study started
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-23
Primary completion date: 2022-11-15
Completion date: 2022-11-15
Plan to share individual participant data: NO
Clinical trial NCT04640571: Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition
Official title: Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition
Sponsor: University of Maryland, Baltimore (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 18.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-04-01
Primary completion date: 2021-11-01
Completion date: 2021-11-01
Baseline population: Dropped participants did not contribute to the analysis.
Clinical trial NCT02652260: Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028)
Official title: Phase IIb, Double-Blinded, Multicenter, Randomized Study to Assess the Effect on Central Nervous System (CNS) Toxicity of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Subjects.
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 86.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-03-04
Primary completion date: 2018-08-14
Completion date: 2024-02-07
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04745104: A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707 in Healthy Young Adult and Elderly Subjects
Sponsor: Atridia Pty Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-02-23
Primary completion date: 2022-03-21
Completion date: 2022-03-21
Plan to share individual participant data: NO
Clinical trial NCT02919072: Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section
Official title: Comparison of Epidural Chloroprocaine 3% and Ropivacaine 0.75% for Unplanned Caesarean Section in Labouring Women Who Have an Epidural Catheter in Situ
Sponsor: Sintetica SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The doctors involved in the study did not enroll any patients
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-10-31
Primary completion date: 2021-06-30
Completion date: 2021-06-30
Clinical trial NCT05178823: Short- and Long Term Antibacterial Effects of a Single Rinse With Different Mouthwashes: a Randomized Clinical Trial
Official title: Short- and Long Term Antibacterial Effects of a Single Rinse With Different Mouthwashes: a Randomized Clinical Trial
Sponsor: Semmelweis University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 171.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-06-01
Primary completion date: 2019-09-01
Completion date: 2020-09-01
Plan to share individual participant data: NO
Clinical trial NCT04124991: Safety and Efficacy Study of Radioembolization in Combination With Durvalumab in Locally Advanced and Unresectable HCC
Official title: A Single-arm, Open-label, Safety and Efficacy Study of Radioembolization With Yttrium-90 Microspheres in Combination With Durvalumab (MEDI4736) in Locally Advanced and Unresectable Hepatocellular Carcinoma (HCC) (SOLID)
Acronym: SOLID
Sponsor: Seoul National University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-12
Primary completion date: 2022-07-06
Completion date: 2022-07-28
Plan to share individual participant data: NO
Clinical trial NCT04255589: A Clinical Trial to Evaluate the Efficacy and Safety of CKD-495
Official title: A Phase 3, Multi-center, Randomized, Double-blind, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-495 in Patients With Acute and Chronic Gastritis
Sponsor: Chong Kun Dang Pharmaceutical (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 242.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-06
Primary completion date: 2021-05-20
Completion date: 2021-05-20
Plan to share individual participant data: NO
Clinical trial NCT04126044: A SINGLE-DOSE, 2-ARM, PHARMACOKINETIC STUDY OF PF-06439535 (CN) AND EUROPEAN UNION SOURCED BEVACIZUMAB IN CHINESE HEALTHY MALE VOLUNTEERS
Official title: A DOUBLE BLIND, RANDOMIZED, PARALLEL-GROUP, SINGLE-DOSE, 2-ARM, COMPARATIVE PHARMACOKINETIC STUDY OF PF-06439535 (CN) AND BEVACIZUMAB SOURCED FROM EUROPEAN UNION ADMINISTERED TO CHINESE HEALTHY MALE VOLUNTEERS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: The study was withdrawn prior to enrollment after a comprehensive review of the biosimilars market and the company's global manufacturing network.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-22
Primary completion date: 2021-07-10
Completion date: 2021-07-10
Plan to share individual participant data: NO
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT05057221: Safety, Tolerability and Efficacy of Uproleselan (GMI-1271) in Patients With COVID-19 Pneumonia
Official title: A Pilot Study to Assess the Safety, Tolerability and Efficacy of Selectin Inhibitor Uproleselan (GMI-1271) in Patients With COVID-19 Pneumonia
Sponsor: University of Michigan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: No more eligible patients were available.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-11-12
Primary completion date: 2022-03-09
Completion date: 2022-03-09
Baseline population: Adults with confirmed severe COVID-19 pneumonia (WHO definition) requiring supplemental oxygen
Plan to share individual participant data: NO
Clinical trial NCT03927144: Study of Sustained Benefit of AMG334 in Adult Episodic Migraine Patients
Official title: A 12-month Prospective, Randomized, Interventional, Global, Multi-center, Active-controlled Study Comparing Sustained Benefit of Two Treatment Paradigms (AMG334 qm vs. Oral Prophylactics) in Adult Episodic Migraine Patients
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 621.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-15
Primary completion date: 2021-10-01
Completion date: 2022-09-30
Baseline population: Full Analysis Set (FAS): Included all participants to whom study treatment had been assigned.
Plan to share individual participant data: NO
IPD sharing description: Data sharing for this study is the responsibility of Novartis. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT04979442: Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma
Official title: A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients With Dedifferentiated Liposarcoma
Acronym: MANTRA
Sponsor: Rain Oncology Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 175.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-14
Primary completion date: 2023-10-01
Completion date: 2023-10-01
Clinical trial NCT04121221: A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
Official title: A Phase III Study in Subjects With Relapsing Forms of Multiple Sclerosis (RMS) to Asses Efficacy, Safety and Tolerability of GA Depot, a Long Acting IM Injection of Glatiramer Acetate, Once Monthly Compared to Placebo
Sponsor: Mapi Pharma Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1016.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-19
Primary completion date: 2023-06-13
Completion date: 2023-06-13
Clinical trial NCT03660943: A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain
Official title: A Randomized, Double-blind, Placebo-controlled, 2-Injection, 52-Week Study to Evaluate the Efficacy and Safety of Intra-articular Injections of CNTX-4975-05 in Subjects With Chronic, Moderate-to-severe Osteoarthritis Knee Pain
Sponsor: Centrexion Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 332.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-09
Primary completion date: 2020-06-11
Completion date: 2020-06-11
Baseline population: The safety population is defined as any subject that received any amount of investigational product
Clinical trial NCT04834362: Insulin for Hyperglycemia in Stroke Trial
Official title: Efficacy and Safety of Human Insulin Versus Analog Insulin in Hospitalized Acute Stroke Patients With Hyperglycemia: a Randomized, Open-label, Single Center Trial
Sponsor: National Institute of Neurosciences and Hospital, Dhaka (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 452.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-05
Primary completion date: 2021-06-20
Completion date: 2021-06-25
Plan to share individual participant data: NO
Clinical trial NCT02551159: Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
Official title: A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 Alone or in Combination With Tremelimumab Versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients
Acronym: KESTREL
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 823.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-10-15
Primary completion date: 2020-07-06
Completion date: 2021-05-21
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT04311411: A Study of Tirzepatide in Overweight and Very Overweight Participants
Official title: Effect of Tirzepatide on Energy Intake and Appetite-and Reward-Related Brain Areas in Overweight/Obese Subjects: A Placebo-Controlled 6-Week Study With Functional MRI
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 114.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-08-24
Primary completion date: 2022-12-16
Completion date: 2022-12-16
Baseline population: All participants who were randomized and received at least 1 dose of study drug.
Plan to share individual participant data: NO