Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Disease (MIRACLE)

A Phase 2b, Randomised, Double-Blind, Active Controlled, Multi Centre Study to Evaluate the Efficacy, Safety and Tolerability of Oral AZD9977 and Dapagliflozin Treatment in Patients With Heart Failure and Chronic Kidney Disease

The purpose of the study is to evaluate the efficacy and safety of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone and to assess the dose-response relationship, dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on urinary albumin to creatinine ratio (UACR). The study will be conducted in participants with heart failure (HF) with left ventricular ejection fraction (LVEF [below 60%]) and chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR [between ≥ 20 and ≤ 60 mL/min/1.73 m^2, with at least 20% of participants with eGFR ≥ 20 to <30 mL/min/1.73^2 and a maximum of 35% of participants with eGFR ≥ 45 mL/min/1.73 m^2]).

Study Overview

• Status: Completed
• Conditions: Heart Failure; Chronic Kidney Disease
• Intervention / Treatment: Drug: Dapagliflozin; Drug: AZD9977

Detailed Description

After screening, eligible participants will undergo a run-in period where all participants receive dapagliflozin for up to 7 weeks depending on pre-study use of SGLT2i or not. At the end of the run-in period, eligible participants will be randomly assigned with a 1:1:1:1 ratio to receive once daily administration of one of the following 4 study treatments group for 12 weeks. To ensure blinding, the study treatment will be administered in the form of 3 oral capsules of AZD9977 or placebo and 1 oral tablet or dapagliflozin.

1. AZD9977 Dose A + dapagliflozin 10 mg
2. AZD9977 Dose B + dapagliflozin 10 mg
3. AZD9977 Dose C + dapagliflozin 10 mg
4. Dapagliflozin 10 mg

Participants will be randomized to one of the above treatment group, according to type 2 diabetes mellitus [T2DM (yes/no)] and eGFR (≥ 20 to <30 mL/min/1.73^2; or ≥ 30 to < 45 mL/min/1.73^2; or ≥45 mL/min/1.73^2).

The total duration of participation will be approximately 22 to 24weeks.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Roeselare, Belgium, 8800
    • Research Site
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Research Site
  • Plovdiv, Bulgaria, 4003
    • Research Site
  • Plovdiv, Bulgaria, 4002
    • Research Site
  • Plovdiv, Bulgaria, 1606
    • Research Site
  • Sofia, Bulgaria, 1431
    • Research Site
  • Sofia, Bulgaria, 1784
    • Research Site
  • Sofia, Bulgaria, 1233
    • Research Site
  • Sofia, Bulgaria, 1309
    • Research Site
  • Sofia, Bulgaria, 1510
    • Research Site
  • Veliko Turnovo, Bulgaria, 5000
    • Research Site
• Canada
  • Quebec, Canada, G1R 2J6
    • Research Site
  • Ontario
    • Peterborough, Ontario, Canada, K9J 0B2
      • Research Site
    • Toronto, Ontario, Canada, M4N 3M5
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
      • Research Site
• Czechia
  • Pardubice, Czechia, 532 03
    • Research Site
  • Praha 2, Czechia, 120 00
    • Research Site
  • Praha 5, Czechia, 158 00
    • Research Site
  • Uherske Hradiste, Czechia, 68601
    • Research Site
• Denmark
  • Aarhus, Denmark, 8200
    • Research Site
  • Herlev, Denmark, 2730
    • Research Site
  • Svendborg, Denmark, 5700
    • Research Site
• Germany
  • Dresden, Germany, 1307
    • Research Site
  • Frankfurt, Germany, 60313
    • Research Site
  • Jena, Germany, 07747
    • Research Site
  • Leipzig, Germany, 04103
    • Research Site
• Hungary
  • Balatonfüred, Hungary, 8230
    • Research Site
  • Budapest, Hungary, 1122
    • Research Site
  • Budapest, Hungary, 1036
    • Research Site
  • Debrecen, Hungary, 4032
    • Research Site
  • Miskolc, Hungary, 3530
    • Research Site
  • Oroshaza, Hungary, H-5900
    • Research Site
• India
  • Ahmedabad, India, 382421
    • Research Site
  • Chennai, India, 600081
    • Research Site
  • Kolkata, India, 700020
    • Research Site
  • Pune, India, 411011
    • Research Site
• Italy
  • Roma, Italy, 00168
    • Research Site
• Japan
  • Chuo-ku, Japan, 103-0027
    • Research Site
  • Hamada-shi, Japan, 697-8511
    • Research Site
  • Hamamatsu-shi, Japan, 430-0929
    • Research Site
  • Hanyu-shi, Japan, 348-8505
    • Research Site
  • Itabashi-ku, Japan, 173-8610
    • Research Site
  • Kasugai-shi, Japan, 487-0016
    • Research Site
  • Kawaguchi, Japan, 333-0842
    • Research Site
  • Kishiwada-shi, Japan, 596-8522
    • Research Site
  • Kobe, Japan, 654-0155
    • Research Site
  • Kobe-shi, Japan, 650-0047
    • Research Site
  • Matsudo-Shi, Japan, 271-0077
    • Research Site
  • Matsumoto-shi, Japan, 390-8621
    • Research Site
  • Ono, Japan, 675-1392
    • Research Site
  • Osaka-shi, Japan, 530-0001
    • Research Site
  • Sapporo-shi, Japan, 006-0811
    • Research Site
  • Sayama, Japan, 350-1305
    • Research Site
  • Takasago-shi, Japan, 676-0812
    • Research Site
  • Takasaki-shi, Japan, 370-0829
    • Research Site
  • Ueda-shi, Japan, 386-8610
    • Research Site
  • Yokohama-shi, Japan, 236-0004
    • Research Site
  • Yokohama-shi, Japan, 231-8682
    • Research Site
  • Yokohama-shi, Japan, 234-8503
    • Research Site
• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Research Site
  • Gangwon-do, Korea, Republic of, 26426
    • Research Site
  • Seongnam-si, Korea, Republic of, 463-707
    • Research Site
  • Seoul, Korea, Republic of, 03080
    • Research Site
  • Seoul, Korea, Republic of, 06351
    • Research Site
  • Seoul, Korea, Republic of, 06591
    • Research Site
• Lithuania
  • Kaunas, Lithuania, 50177
    • Research Site
  • Klaipeda, Lithuania, 92231
    • Research Site
  • Siauliai, Lithuania, LT-76231
    • Research Site
  • Vilnius, Lithuania, 08661
    • Research Site
• Poland
  • Gdansk, Poland, 80-952
    • Research Site
  • Gdańsk, Poland, 80-382
    • Research Site
  • Katowice, Poland, 40-040
    • Research Site
  • Lublin, Poland, 20-709
    • Research Site
  • Ostrowiec Świętokrzyski, Poland, 27-400
    • Research Site
  • Oława, Poland, 55-200
    • Research Site
  • Oświęcim, Poland, 32-600
    • Research Site
  • Pabianice, Poland, 95-200
    • Research Site
  • Poznań, Poland, 60-702
    • Research Site
  • Skorzewo, Poland, 60-185
    • Research Site
  • Sopot, Poland, 81-717
    • Research Site
  • Szczecin, Poland, 71-434
    • Research Site
  • Toruń, Poland, 87-100
    • Research Site
  • Warszawa, Poland, 01-192
    • Research Site
  • Łódź, Poland, 92-213
    • Research Site
  • Łódź, Poland, 90-127
    • Research Site
  • Łódź, Poland, 95-513
    • Research Site
• Russian Federation
  • Kazan, Russian Federation, 420101
    • Research Site
  • Kazan, Tatarstan, Russian Federation, 420012
    • Research Site
  • Kemerovo, Russian Federation, 650002
    • Research Site
  • Moscow, Russian Federation, 121552
    • Research Site
  • Moscow, Russian Federation, 125284
    • Research Site
  • Moscow, Russian Federation, 111539
    • Research Site
  • Moscow, Russian Federation, 129110
    • Research Site
  • Saint-Petersburg, Russian Federation, 195257
    • Research Site
  • St Petersburg, Russian Federation, 195067
    • Research Site
  • St. Petersburg, Russian Federation, 197022
    • Research Site
  • St. Petersburg, Russian Federation, 197089
    • Research Site
• Slovakia
  • Banska Bystrica, Slovakia, 974 01
    • Research Site
  • Brezno, Slovakia, 977 01
    • Research Site
  • Lucenec, Slovakia, 984 01
    • Research Site
  • Presov, Slovakia, 080 01
    • Research Site
  • Svidnik, Slovakia, 08901
    • Research Site
  • Trencin, Slovakia, 911 01
    • Research Site
• Spain
  • Barcelona, Spain, 08003
    • Research Site
  • Coruña, Spain, 15006
    • Research Site
  • El Palmar, Spain, 30120
    • Research Site
  • Madrid, Spain, 28041
    • Research Site
  • Málaga, Spain, 29010
    • Research Site
  • Santiago(A Coruña), Spain, 15706
    • Research Site
  • Sevilla, Spain, 41009
    • Research Site
  • Valencia, Spain, 46010
    • Research Site
  • Valencia, Spain, 46026
    • Research Site
• Sweden
  • Goeteborg, Sweden, 413 46
    • Research Site
  • Stockholm, Sweden, 14186
    • Research Site
  • Stockholm, Sweden, 18288
    • Research Site
  • Uppsala, Sweden, 75185
    • Research Site
• Taiwan
  • Kaohsiung, Taiwan, 80756
    • Research Site
  • Taichung, Taiwan, 40201
    • Research Site
  • Taipei, Taiwan, 10449
    • Research Site
  • Taipei, Taiwan, 11217
    • Research Site
  • Taipei City, Taiwan, 110
    • Research Site
• Thailand
  • Bangkok, Thailand, 10400
    • Research Site
  • Bangkok, Thailand, 10700
    • Research Site
  • Chaingmai, Thailand, 50200
    • Research Site
  • Khon Kaen, Thailand, 40002
    • Research Site
• Turkey
  • Adana, Turkey, 01060
    • Research Site
  • Kocaeli, Turkey, 41380
    • Research Site
• Ukraine
  • Ivano-Frankivsk, Ukraine, 76018
    • Research Site
  • Kharkiv, Ukraine, 61039
    • Research Site
  • Kyiv, Ukraine, 02091
    • Research Site
• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Research Site
    • Fountain Valley, California, United States, 92708
      • Research Site
    • Northridge, California, United States, 91324
      • Research Site
    • S. Gate, California, United States, 90280
      • Research Site
  • Florida
    • Hialeah, Florida, United States, 33016
      • Research Site
    • Homestead, Florida, United States, 33032
      • Research Site
    • Jacksonville, Florida, United States, 32216
      • Research Site
    • Miami, Florida, United States, 33155
      • Research Site
    • Ocala, Florida, United States, 34474
      • Research Site
    • Tampa, Florida, United States, 33603
      • Research Site
  • Georgia
    • Augusta, Georgia, United States, 30904
      • Research Site
    • Columbus, Georgia, United States, 31904
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Research Site
  • Massachusetts
    • Methuen, Massachusetts, United States, 01844
      • Research Site
  • Missouri
    • Saint Louis, Missouri, United States, 63136
      • Research Site
  • New York
    • Bronx, New York, United States, 10455
      • Research Site
  • North Carolina
    • New Bern, North Carolina, United States, 28562
      • Research Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Research Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Research Site
  • Texas
    • Houston, Texas, United States, 77087
      • Research Site
    • Houston, Texas, United States, 77099
      • Research Site
    • Kingwood, Texas, United States, 77339
      • Research Site
    • McKinney, Texas, United States, 75069
      • Research Site
    • San Antonio, Texas, United States, 78207
      • Research Site
    • Sherman, Texas, United States, 75092
      • Research Site
    • Webster, Texas, United States, 77598
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participants are included in the study if any of the following criteria apply:

• Documented diagnosis of stable symptomatic HF (New York Heart Association class II-III) at screening, and a medical history of typical symptoms and signs of HF in those who are currently receiving loop diuretic treatment
• Left ventricular ejection fraction <60% documented by the most recent echocardiogram or cardiac magnetic resonance imaging within the last 12 months prior to screening
• Stable background treatment for HF, hypertension, diabetes mellitus or renal disease according to guidelines
• N-terminal-pro-brain natriuretic peptide (NT proBNP) ≥300 pg/mL for participants with sinus rhythm at screening; and NT proBNP ≥600 pg/mL for participants with atrial fibrillation/flutter at screening
• The eGFR ≥30 and ≤60 mL/min/1.73^2 (by CKD- EPI formula) and UACR ≥30 mg/g (3 mg/mmol) and <3000 mg/g (300 mg/mmol)
• Body mass index less than 40 kg/m^2
• Serum/plasma K+ level ≥ 3.5 and < 5.0 mmol/L within 10 days prior to randomization
• Serum/ plasma Na+ level within normal reference values within 10 days prior to randomization
• Systolic blood pressure should be at protocol defined range at randomization (Visit 3), with no change to antihypertensive treatments in previous 3 weeks
• Male or female of non-childbearing potential
• All participants must follow protocol defined contraceptives procedures

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

• Primary glomerulopathy, vasculitic renal disease, prior dialysis or unstable rapidly progressing renal disease, autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or anti-neutrophil cytoplasm antibody-associated vasculitis
• Participants with currently decompensated HF requiring hospitalization for optimization of HF treatment and are not on stable HF therapy at the time of enrollment
• HF due to cardiomyopathies
• High output HF (e.g., due to hyperthyroidism or Paget's disease)
• HF due to pericardial disease, congenital heart disease or clinically significant uncorrected primary cardiac valvular disease or planned cardiac valve repair/replacement
• Participants with uncontrolled diabetes mellitus (Glycated hemoglobin >10%)
• Participants with Type 1 diabetes mellitus
• Intermittent or persistent 2nd or 3rd degree atrioventricular block, sinus node dysfunction with clinically significant bradycardia or sinus pauses, not treated with a pacemaker
• History of any life-threatening cardiac dysrhythmia or uncontrolled ventricular rate in participants with atrial fibrillation or atrial flutter
• Acute coronary syndrome and/or elective/non-elective percutaneous cardiac interventions (within 3 months) prior to randomisation or is planned to undergo any of these procedures during the study
• Any major cardiovascular (eg, open chest, coronary artery bypass grafting or valvular repair/replacement) or major non-cardiovascular surgery within 3 months prior to randomisation or is planned to undergo any cardiovascular surgery during the study
• Heart transplantation or left ventricular assist device at any time or if these are planned
• Kidney or any organ transplantation or if these are planned
• Medical conditions associated with development of hyperkalaemia (Addison's disease )
• History or ongoing allergy/hypersensitivity, to sodium-glucose co-transporter-2 inhibitor (SGLT2i e.g., dapagliflozin, empagliflozin)
• Stroke, transient ischemic attack, carotid surgery, or carotid angioplasty within previous 3 months prior to randomisation
• Hepatic disease, including hepatitis and/or hepatic impairment (Child-Pugh class A-C), and aspartate aminotransferase or alanine transaminase or total bilirubin should be in protocol defined range at time of screening and/ or within 7 days prior to randomization
• Participants with newly detected pathological laboratory values or an ongoing disease condition
• If the participants clinical signs and symptoms consistent with COVID-19, and has been previously hospitalized with COVID-19 infection and did not fully recover their previous health status
• Previous randomization in the present study
• Prior medical treatment with an mineralocorticoid receptor antagonist where the medication was taken within 90 days prior to screening
• Current or prior treatment within 6 months prior to screening with cytotoxic therapy, immunosuppressive therapy, or other immunotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AZD9977 Dose A + dapagliflozin 10 mg; Participants will receive once daily oral dose A of AZD9977 and 10 mg dapagliflozin for 12 weeks.	Drug: Dapagliflozin; Participants will receive dapagliflozin as per the arms they are randomized.; Drug: AZD9977; Participants will receive AZD9977 as per the arms they are randomized.
Experimental: AZD9977 Dose B + dapagliflozin 10 mg; Participants will receive once daily oral dose B of AZD9977 and 10 mg dapagliflozin for 12 weeks.	Drug: Dapagliflozin; Participants will receive dapagliflozin as per the arms they are randomized.; Drug: AZD9977; Participants will receive AZD9977 as per the arms they are randomized.
Experimental: AZD9977 Dose C + dapagliflozin 10 mg; Participants will receive once daily oral dose C of AZD9977 and 10 mg dapagliflozin for 12 weeks.	Drug: Dapagliflozin; Participants will receive dapagliflozin as per the arms they are randomized.; Drug: AZD9977; Participants will receive AZD9977 as per the arms they are randomized.
Experimental: Dapagliflozin 10 mg; Participants will receive once daily oral dose of dapagliflozin 10 mg alone for 12 weeks.	Drug: Dapagliflozin; Participants will receive dapagliflozin as per the arms they are randomized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12	The effect of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone on UACR assessed. Urine samples were collected for the analysis of UACR. UACR (milligrams per gram [mg/g]) was calculated as 10 x urine albumin (mg per deciliter [mg/dL])/urine creatinine (g/dL). Change from baseline in UACR at the end of 12 weeks of study treatment was calculated as the average of the UACR values at Week 12 and was analyzed by a mixed-effects model for repeated measures (MMRM). Due to early removal of arms (AZD9977 150 mg monotherapy and Placebo), the study objectives were revised and the MMRM analysis included the 4 remaining arms (AZD9977 15 mg + Dapagliflozin, AZD9977 50 mg + Dapagliflozin, AZD9977 150 mg + Dapagliflozin, and Dapagliflozin 10 mg). Since 2 arms were removed from the study resulting in fewer participants only descriptive statistics are shown for those two arms without formal comparison.	Baseline (Day 1) to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at 12 Weeks to Assess Dose-Response Relationship	The dose-response relationship of dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on UACR was assessed. Urine samples were collected for the analysis of UACR. UACR (mg/g) was calculated as 10 x urine albumin (mg/dL)/urine creatinine (g/dL). Change from baseline in UACR at the end of 12 weeks of study treatment was calculated as the average of the UACR values at Week 12 and was analyzed by a mixed-effects model for repeated measures (MMRM). Due to early removal of arms (AZD9977 150 mg monotherapy and Placebo), the study objectives were revised and the MMRM analysis included the 4 remaining arms (AZD9977 15 mg + Dapagliflozin, AZD9977 50 mg + Dapagliflozin, AZD9977 150 mg + Dapagliflozin, and Dapagliflozin 10 mg). Since 2 arms were removed from the study resulting in fewer participants, only descriptive statistics was shown for those two arms without formal comparison.	Baseline (Day 1) to Week 12
Number of Participants With Adverse Events (AEs)	The safety and tolerability of AZD9977 combined with dapagliflozin 10 mg, AZD9977 monotherapy, dapagliflozin 10 mg monotherapy and placebo was assessed.	From baseline (Day 1) until Day 113
Change From Baseline in Serum Potassium (K+)	Effect of AZD9977 combined with dapagliflozin 10 mg, AZD9977 monotherapy, dapagliflozin 10 mg monotherapy and placebo on serum K+ was assessed.	Baseline (Day 1) and Week 12
Absolute Value of Serum Potassium Over Time	Effect of AZD9977 combined with dapagliflozin 10 mg, AZD9977 monotherapy, dapagliflozin 10 mg monotherapy and placebo on serum K+ was assessed.	Baseline (Day 1) and Week 12
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)	Effect of AZD9977 combined with dapagliflozin 10 mg, AZD9977 monotherapy, dapagliflozin 10 mg monotherapy and placebo on eGFR was assessed.	Baseline (Day 1) and Week 12
Absolute Value of eGFR Over Time	Effect of all doses of AZD9977 combined with dapagliflozin 10 mg, AZD9977 monotherapy, dapagliflozin 10 mg monotherapy and placebo on eGFR was assessed	Baseline (Day 1) to Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs) and serious adverse events (SAEs)	Assessment of the general safety and tolerability of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone.	From baseline (Day 1) until Day 113 (Safety Follow-up)
Absolute value of serum potassium over time	Assessment of the effect of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone on serum potassium.	Days 1, and 3 until Day 85
Change from baseline in serum potassium over time	Assessment of the effect of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone on serum potassium.	From baseline (Day 1), Day 3 until Day 85
Absolute value of eGFR over time	Assessment of the effect of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone on eGFR.	Days 1, and 3 until Day 85
Change from baseline in eGFR over time	Assessment of the effect of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone on eGFR.	From baseline (Day 1), Day 3 until Day 85

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: John McMurray, University of Glasgow, United Kingdom

Publications and helpful links

Helpful Links

• Redacted CSR Synopsis_D6402C00001

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Actual): September 22, 2023
• Study Completion (Actual): September 22, 2023

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Heart Failure; Dapagliflozin; Chronic kidney disease; Type 2 diabetes mellitus; Diabetic kidney disease; AZD9977; Mineralocorticoid receptor modulator; Sodium-glucose co-transporter-2 inhibitor; Urinary albumin creatinine ratio
• Additional Relevant MeSH Terms: Urogenital Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Chronic Disease; Disease Attributes; Renal Insufficiency; Heart Failure; Kidney Diseases; Renal Insufficiency, Chronic; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Dapagliflozin
• Other Study ID Numbers: D6402C00001; 2020-003126-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan 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 requests 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 Sharing 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 Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No